Effect of Group Led Creative Writing on Mood in Cancer Patients
Phase: NA
Conditions: Cancer Patients
Sponsor: Milton S. Hershey Medical Center

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HRP-591 - Protocol for Human Subject Research 
Application for Review of Human Research: IRB Protocol Summary
Protocol Title: Effect of Group Led Creative Writing on Mood in Cancer Patients
Principal Investigator:
Name: Monika Joshi, MD, MRCP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: mjoshi@pennstatehealth.psu.edu
Co-Investigators: 
Name: Muhammad Hussain, MD (Co-PI)
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-0003 Ext:285177
E-mail Address: mhussain2@pennstatehealth.psu.edu
Name: Darya Nesterova, BS (Co-PI)
Department: College of Medicine
Telephone: 571-723-5722
Email: dnesterova@pennstatehealth.psu.edu
Name: Monali Vasekar, MD
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-8678
E-mail Address: mvasekar@pennstatehealth.psu.edu
 
Name: Jacqueline Heath, BS 
Department: College of Medicine
Telephone: 201-647-7084
Email: jheath2@pennstatehealth.psu.edu
Name: Joseph Drabick, MD FACP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: jdrabick@pennstatehealth.psu.edu
Name: Cristina Truica, MD
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: ctruica@pennstatehealth.psu.edu
 
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Name: Michael Hayes, Ph.D.
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-0003 Ext: 289370
E-mail Address: mhayes3@pennstatehealth.psu.edu
 
Biostatistician
Name: Junjia Zhu Ph.D.
Department: Public Health Services
Division: Biostatics
Telephone: 717-531-1509
E-mail Address: jzhu@phs.psu.edu
Collaborators:
Name: Aditya Joshi, MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-2947
E-mail Address: auj3@psu.edu
Name: Erika F.H Saunders MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531- 8516
E-mail Address:efs11@psu.edu
Version Date:
August 30th, 2018
Clinicaltrials.gov Registration #: N/A
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College of Medicine and Hershey Medical Center:
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(Physical Office Location: Academic Support Building Room 1140)
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Email: irb-hspo@psu.edu
Instructions for using this protocol template:
1.
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Information” section. Links to Penn State’s protocol templates are available in the same location where 
they are uploaded, and their use is required.
2.
This template is provided to help investigators prepare a protocol that includes the necessary 
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MUST be deleted from the final version of the protocol prior to upload to CATS IRB.
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Table of Contents
1.0
PROTOCOL TITLE
2.0
STUDY SPONSORSHIP
3.0
PROTOCOL ABSTRACT
4.0
OBJECTIVES
5.0
BACKGRUND
6.0
RATIONALE AND HYPOTHESIS
7.0
CHARACTERISTICS OF STUDY POPULATION
7.1 TARGET POPULATION
7.2 ACCURAL
7.3 KEY INCLUSION CRITERIA
7.4 KEY EXCLUSION CRITERIA
7.5 VULNERABLE POPULATION
7.6 POPULATIONS VULNERABLE TO UNDUE INFLUENCE OR COERCION
7.7 SUBJECT RECRUITMENT
8.0
CONSENT PROCESS AND DOCUMENTATION
9.0
STUDY DESIGN
9.1 PHASE
9.2 DESIGN
9.3 DURATION
9.4 ENDPOINTS
9.5 STUDY SCHEMA
10.0
STUDY PROCEDURES
10.1 METHODS
10.2 CLINICAL COVARIATES
10.3 CREATIVE WORKSHOP
10.4 EMOTIONAL THERMOMETER SCALE
10.5 CONTROL GROUP ACTIVITES
11.0
STATISTICAL PLAN
12.0
CONFIDENTIALITY
13.0
PRIVACY
14.0
DATA AND SAFETY MONITORING
15.0
RISK/BENEFIT ASSESMENT
16.0
SUBJECT COMPENSATION
17.0
NUMBER OF SUBJECTS
18.0
RESOURCES AVAILABLE
19.0
ADVERSE EVENT REPORTING
20.0
STUDY MONITORING, AUDITING AND INSPECTING
21.0
REFERENCES
22.0
TABLES
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1.0
PROTOCOL TITLE
1.1
Effect of Group Led Creative Writing on Mood in Cancer patients.
1.2
Brief Title: Effect of Creative Writing on Mood in Cancer Patients.
2.0
STUDY SPONSORSHIP
2.1
Funding Sponsor:
Penn State Hershey Cancer Institute
Fifty Shades of Pink (Breast Cancer Endowment Fund)
2.2
Primary Sponsor:
Penn State Hershey Cancer Institute
3.0
PROTOCOL ABSTRACT
The primary purpose of this study is to determine whether creative writing in newly diagnosed cancer 
patients and those with recent progression in their disease will have a positive impact on their mental 
health. Using a randomized controlled trial approach, emotion thermometers will be employed to 
evaluate participants’ responses on a number of domains, such as anxiety, depression, despair, and 
anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. 
Open-ended survey questions will be used to capture how a creative writing intervention impacts 
participants’ experience of their illness. Melissa Greene’s Write from the Heart program focuses more 
on creative writing rather than cancer focused topics. Patients in the intervention arm will complete –
one and a half hour group sessions every two weeks over the span of 3 months. Participants in the 
active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg) about 
creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a period of 2-3 months.
4.0
OBJECTIVES
4.1
Primary Objectives:  

Mental wellness before and after intervention in the intervention and control groups. A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
reflecting participants’ mental health pre- and post-intervention. Survey questions 
focused on symptoms of depression and anxiety will be used to monitor for changes in 
mental wellness pre- and post-intervention. 
4.2
Secondary Objectives: 

Comparison of mood scores, depression and anxiety symptoms versus frequency of 
attendance in the intervention arm. 

Comparison of somatic symptom burden between intervention and control group.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms after workshop between genders. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between patients living alone versus with family.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between various cancer types.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who have previously attended a creative writing class versus 
those who have not. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who completed control group activity and then enrolled in the 
workshops and attended at least one session. 

Comparison of the frequency of emergency room visits and hospitalizations between 
intervention and control group during the study period.
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
Comparison of cancer status (stable, progressing, in remission) between intervention 
and control group.
5.0
BACKGROUND
5.1 Scientific Background and Gaps 
Cancer is a life-threatening, feared diagnosis and is a source of great distress in patients. Hence in 
addition to treating cancer, one must address the emotional well-being of patients. 
Creative activity has a significant history in providing a wide range of psychological and 
physiological benefits for cancer survivors (King et al., 2012). When individuals experience a stressful 
life event or crisis, the higher verbal functions in the cerebral cortex become less accessible (Hass-
Cohen, 2008.) Therefore, patients who face such stressful life events of cancer are often left without 
words to describe their experiences of feelings (Green & Young, 2015). Findings from Green and 
Young (2015) suggest that creative visual expression, engaging both in an individual and the 
therapeutic setting, offered an opportunity for young adult survivors to express their emotions from 
deep within their bodies. It created self-understanding and a sense of healing. 
In another study by Bolton (2007) patients indicated that they found the therapeutic writing process 
beneficial. For example, one participant narrated, “It made it less traumatic than it might have been 
otherwise.” Creative writing has been recognized to explore and express personal thoughts, feelings, 
and experiences. Lau Tsu (1973) showed that writing facilitated patients’ ability to discover what they 
thought felt and remembered. Therapeutic creative writing enhanced their awareness of and ability to 
express issues to which attention and focus are required. (Esterhing BA et al., 1999)
There is a substantial area of agreement that language, narrative storytelling, forms an essential 
element in the construction of a coherent identity, sense of self and connectedness to others, and 
therefore, it is a powerful tool in creative therapy (Smyth, 1998; Wright & Chung, 2001). Roe and 
Davidson (2005) argue that processes of re-authoring one’s life story are actually integral components 
of the recovery process itself. A study by Stanton (2002) of breast cancer patients prompted to write 
about their cancer experience showed a significant decrease in self-reported somatic symptoms and 
medical appointment visits for cancer-related morbidities three months after participation in the study. A 
follow-up study by Stanton (2013) encouraged breast cancer patients to create personal websites to 
chronicle their experience and to communicate with their social network. This study showed significant 
improvement in positive mood and depressive symptoms after 6 months, particularly in patients 
undergoing medical therapy at that time.  These studies further support that the act of narrative story 
telling can improve patient wellbeing. 
Furthermore, King et al. (2012) suggest that writing can contribute to repair of symbolic functioning 
and contribute to the development of personal identity. The researchers concluded that, of all the 
creative arts, writing is least dependent on equipment and/or special environments. Writing workshops 
are probably better provided by professional writers than by mental health professionals. When health 
professionals provide activities such as a writing workshop, there is a risk that identification with the 
illness is reinforced. On the other hand, when a professional writer provides a similar activity, it is the 
participant’s identity as a writer that is reinforced, rather than their identity as a person with an illness. 
(King et al., 2012)
Moreover, there is emerging consensus in the UK and USA that there might be advantages if 
writing therapy is received from facilitators who themselves are trained writers and can work in 
collaboration with health care professionals. (Hunt & Sampson, 1998; Mc Loughlin, 2004).
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  5.2   Previous Data 
We conducted a pilot study to determine feasibility whether cancer patients can be enrolled, 
randomized and retained for four weeks for creative writing classes (Feasibility was defined as 50% of 
our enrolled patients on intervention arm (IA) could attend at least 2 classes). We anticipated enrolling 
45 patients over the period of 2 months with randomization into 2 arms: IA and standard of care (SOC). 
“Write from the Heart” a series of creative writing workshops (CWW) were conducted on IA. Subjects in 
IA had four, 2-hour weekly CWW whereas SOC arm did not receive any session. We used validated 
Emotional Thermometer Scales (ETS), ranging 0 (best)-10 (worst), to predict changes in a number of 
parameters reflecting patient’s mental health pre and post intervention. ETS has five dimensions 
(distress, anxiety, depression, anger and need help), which are all continuous variables.  Due to time 
constraints we were not able to accrue the desired number of patients. A total of 16 patients were 
accrued in 1 month period -11 in IA and 5 in SOC. 7 out of 11 (63%) patients enrolled in IA attended at 
least 75% of classes. Comparisons were made using two-sample T-tests. Although sample size was 
small, IA did show a decreasing pattern on Total Emotion Score (TES), particularly in depression and 
anxiety scores (See table 1 and figure 1, 2). For each visit, post-class scores were lower than pre-class 
scores. We observed that it is feasible for cancer patients to attend focused workshops geared towards 
mental health wellbeing. IA showed a trend towards mood improvement, although was not shown to be 
statistically significant which may be attributed to the small sample size. Having shown the feasibility of 
such a study, we hope to increase the sample size and include more specific methods for quantifying 
mood improvement in the patient groups. In addition, after reviewing the suggestions (post completion 
of the study) from the patients who attended these sessions on the study, we concluded that 1.5hours 
of class twice a month is feasible and helpful for patients. 
Table 1: Mean and Median TES at baseline and after intervention in SOC versus IA.
Fig 1: Total Emotions Scores before and after each 
visit.
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Fig 2, A-D: Emotions Scores before and after each visit; A-D: A-Distress, B-Depression, C-Anxiety, D- Anger
6.0
RATIONALE AND HYPOTHESIS
6.1
RATIONALE:
Cancer generates an increased sense of distress than non-malignant diseases with poor 
prognoses (Mishel et al., 1984). Persistent mental distress for prolonged periods leads to anxiety and 
depression. The rate of depression in cancer patients is thought to be up to three times higher than in 
the general population (Linden et al., 2012). Depression leads to a poorer quality of life (QOL) and 
affects patient outcomes, with depression resulting in higher rates of mortality in cancer (Colleoni et al., 
2000, Pinquart et al., 2010). A meta-analysis revealed that minor or major depression increases 
mortality rates by up to 39%, and that patients displaying even few depressive symptoms may be at a 
25% increased risk of mortality (Satin et al., 2009). The impact of mood and mental wellbeing on cancer 
progression is considered important by doctors and patients, with >70% of oncologists and 85% of 
patients believing that mood affects the progression of cancer (Lemon et al., 2004). Our previous data 
as mentioned before shows that creative writing is feasible and needs to be further studied to 
understand the effect of group therapy with focused workshop in newly diagnosed or patients with 
recent recurrence. In addition, we observed that the emotional thermometer scale was not enough to 
capture the mood of the patients. For example, some patients felt significantly better after attending 
these sessions and were able to cope with their symptoms but the emotional scale did not reflect that 
benefit. 
6.2
HYPOTHESIS:
This study aims to look at the impact of participating in creative writing workshop group Write 
from the Heart, on cancer patients’ emotional well-being. Keeping previous studies in mind, a 
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professional writer will conduct the workshops, which will enhance the participant’s ability to express 
and enhance their awareness. We anticipate that participation in the workshop will result in a positive 
effect on the parameters being studied, enabling patients to cope with their illness/cancer better.  We 
hypothesize that group sessions of creative writing workshop could be better than individual sessions. 
7.0
CHARACTERISTICS OF THE STUDY POPULATION
7.1
Target Population
Adults with a new diagnosis of cancer, at any stage OR progression of  
cancer- within three months of enrollment.   
7.2
Accrual
We aim to accrue 60 eligible patients over a time span of 4months at the Milton S. Hershey 
Medical Center.
7.3
Key Inclusion Criteria

Adult >20 years of age 

Any patient with a cancer diagnosis. 

Ability to understand English language and ability to write without any functional difficulty

ECOG performance status 0-3
7.4
Key Exclusion Criteria 

Inability to give informed consent

Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis) 

Severe cognitive impairment

Pregnant females

Inability to write or understand English
7.5
Vulnerable Populations 
None
7.6
Populations vulnerable to undue influence or coercion
If a patient who works for or has some affiliation to Pennsylvania State University happens to be 
in the potential participant pool, we will verbally stress to him/her that their participation is 
voluntary and will not influence her care or any outcomes related to Penn State. 
7.7
Subject Recruitment 
We will recruit participants from our outpatient cancer clinics at HMC (Hershey Medical Center). 
We will create a pamphlet describing our study briefly and study staff contacts, then distribute in 
all cancer clinics. This will be given to every cancer patient at any stage, with recurrence, or with 
progression at HMC. We will also send emails to physicians and nurses at outpatient cancer 
clinics at HMC for study description and our contact details. If patients are interested, we (study 
staff) will conduct initial eligibility screening and obtain informed consent from patients to initiate 
study follows up. 
8.0
CONSENT PROCESS AND DOCUMENTATION
8.1
Consent Process
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8.1.1
Obtaining Informed Consent
Physician-Investigators of the study will identify patients from their clinic and 
patients will be approached to participate in the study. Study staff will then discuss the study in 
detail to make the patient aware of the workshops, intervention, and time commitment involved 
with the study. If the patient is interested, study staff will answer any remaining questions and 
obtain written informed consent at the patient’s clinic visit with their primary oncologist.
8.1.2
Coercion or Undue Influence during Consent
If a patient affiliated with Pennsylvania State University happens to be in the potential 
participant pool, we will inform them that their participation is voluntary and will not influence her 
care or any outcomes related to Penn State. 
8.1.3  Waiver of Authorization
Not applicable
8.2
Consent Documentation
8.2.1
Written Documentation of Consent
Study staff members will assist with data and consent collection. If the patients are unable or not 
competent to give consent, they will not be enrolled in the study.
8.3
Consent – Other Considerations 
8.3.1.1 Non-English Speaking Subjects
Not included.
8.3.1.2 Cognitively Impaired Adults
Not included.
8.3.1.3 Subjects who are not yet adults (i.e., infants, children, teenagers) 
Inclusion criteria: greater than 20 years of age
9.0
STUDY DESIGN
  
9.1
Phase
Phase II
9.2
Design
The focus of this study is to determine the difference in mental health parameters following the 
participation of cancer patients in a creative writing workshop. Participants will be randomized 
within strata formed by cancer type in order to assure that these potentially important 
confounding variables are balanced across groups. Patients will be enrolled on a rolling basis 
over a four to five-month period, allowing patients in intervention arm to participate in 2-3 
months workshops (workshops would be held once every 2 weeks). Patients in control arm will 
be provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be 
asked to do activities for 1.5 hours every 2 weeks. After three months, control group participants 
can join creative writing workshops at their discretion for the remaining period for writing 
workshops. Both group members will receive follow up surveys twice a month for two months at 
the completion of the participant’s two-month study period.  
9.3
Study Duration 
Estimated time to enroll all subjects = 3-5 months (Patients will start being enrolled after IRB 
approval and we will continue the enrollment up to 4-5 months from the time the 1st class starts 
 for the intervention group)
Length of a participant's participation = 2 - 6 months; Follow up after participant’s completion of 
classes = 2 months 
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9.4
Endpoints:
9.4.1
Primary endpoints: 

Mood scores before (at baseline) and after intervention (after completion of entire 
sessions - this may vary as some patients may not be able to complete six sessions). A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
pre and post-intervention.

Severity of depression and anxiety symptoms before and after intervention between two 
groups. Validated Depression and Anxiety questionnaires will be used to predict 
changes, the PHQ-9 and GAD-7 respectively. 
9.4.2
Secondary endpoints: 

Mood and symptoms before and after at least 2 sessions of intervention. 

Self-reported somatic symptoms pre and post intervention in two groups. We will use the 
Somatic Symptom Scale – 8 (SSM-8) to quantify somatic symptom burden. 

Difference in scores and symptoms between various genders.

Difference in scores and symptoms between patients living alone versus with family.

Difference in scores and symptoms in different cancer types.  

Difference in scores and symptoms versus number of classes attended. 

Differences between individual mood scores for patients in the control group who later 
switch to intervention group and attend at least one session

Mood and symptom scores up to 2 months after completion of the study. 
9.4.3    Exploratory endpoints

Difference in number of emergency room visits and hospitalizations during study period 
between control and intervention group. 

Comparison of status of cancer (stable, progressing, in remission) between intervention 
and control group.
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9.5
Study Schema
                        Figure 1:
Enrollment in clinic 
setting
Intervention n= 40
1.5 hours  twice a month 
(every other week or per 
patient's convenience) 
with Melissa Greene for 2 
months 
Rolling enrollment  during 
first 4.5 months  of the 6 
month workshop series with 
the intention that patients 
enrolled can attend 2 
consecutive months
Control n= 20
Receive Creative Writing 
workbook to do for 1.5 
hours every other week for 
2-3 consecutive months
Patients who complete 
control criteria during first 
2-3 months or more are 
given the opportunity to 
join intervention arm for 
the remainder of the study 
duration- their individual 
data will be collected and 
compared to their previous
All patients would be 
followed for 2 months post 
completion of their 
assigned initial 2-3 month 
clasess
Patient population
N=60
Inclusion criteria: 
-Any patient with a cancer 
diagnosis.
-Ability to understand English 
language and ability to write 
without any functional difficulty
-ECOG performance status 0-3
Primary end points:
1. Mood scores
2. Depression and Anxiety scores 
10.0
STUDY PROCEDURES
10.1
Methods:   After enrollment as above, co-investigators of this study or the assigned 
coordinator will be doing the consent. Patient will be randomized to intervention and control 
arms in a 2:1 ratio. The intervention arm will receive a dedicated workshop for one and a half 
hours every 2 weeks.  We aim to start a 6 month long program with weekly creative writings 
workshops, and patient enrollment in the study will continue through the 1st 4.5 months of the 6 
month period so that the last enrolled patient could complete 2 classes per month for two 
months. Each patient will be asked to attend at least two classes per month for a total of two 
months. These workshops will be held at Hershey Medical Center (HMC). At the initiation of the 
study along with consent we will collect baseline scores in both groups for each parameter as 
below. Somatic Symptom Burden (SSM-8 - Figure 2 - reference section), depression symptoms 
using PHQ-9 (Figure 3 – reference section), and anxiety symptoms using GAD-7 (Figure 4 –
reference section) will be collected monthly and following intervention completion. 
We will collect mood scores pre and post each session. We will use Emotional Thermometer 
Scale (EMS) from Dr. Alex J. Mitchell (Feb. 2010), diagram for scales is shown in figure 1. 
Please see supplementary index for a letter of permission to use from Dr. Mitchell. We will give 
the Thermometer scales and collect scores pre and post each session and also collect scores 
pre and post completion of entire course. Control group will do EMS on monthly basis along with 
other parameters. At the end of the study we will review all participants’ medical charts to count 
view the number of emergency room visits and hospitalizations each participant experienced 
during the study period. These will be further broken down in categories based on cancer 
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related vs non-cancer related visits.  We will also review their most current cancer disease 
status after completion of the workshops and categorize whether their status is considered to be 
stable, progressing, or in remission. Both groups will also receive follow up mood and symptom 
surveys twice a month for up to 2 months after completion of the participant’s two to three 
month study period. 
The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative 
writing and asked to read and do writing activities for one and a half hours once every two 
weeks. At the completion of the two-month participation or completion of 4 sessions control 
patients will be given the opportunity to enroll in the creative writing workshops for the 
remainder of the study period of 6 months. We will collect scores from control arm through the 
same Emotion Thermometers Scale on a monthly basis. Pre-intervention scores will be 
obtained at the time of consent or one week prior to the planned start of session 1 for workshop 
(either in the clinic if possible or mail the score sheet to patients with an enclosed stamped 
envelope for return of the scales). Depending on participant preference, we can send them 
emails of the REDCAP surveys containing the same information at set intervals. A sample of the 
REDCAP surveys is included in supplementary materials. We will also send participants in the 
control arm a stamped return envelope on a monthly basis if not able to get score sheets in a 
clinic or over REDCAP, depending on patient convenience and preference. We will call the 
participants once every 3-4 weeks to check in on their progress. Please see a calendar at the 
end for details. 
To assess for possible confounding results of patients participating in the concurrent exercise 
study, we will ask participants if they are also enrolled in the exercise study at enrollment and 
perform a subset analysis for patients who are in the exercise study. They will be randomized 
into either control or intervention group in the same manner as the other patients in the study. 
We will additionally include a section of the survey to ask about regular exercise (more than 30 
minutes, three times a week) and do a subset analysis of these patients as well.   
 
We will be collaborating with the Department of psychiatry at HMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who requests psychiatry follow up will be 
referred to Dr. Michael Hayes.  If participants report the presence of suicidal ideation per 
question nine on the PHQ-9 [i.e., Thoughts that you would be better off dead or of hurting 
yourself in some way], they will be referred on an urgent basis to Dr. Michael Hayes or Dr. 
Aditya Joshi. In the event Dr. Hayes and/or Dr. Joshi are unavailable for follow-up,  If any active 
suicidal thoughts are reported, participants will be referred directly to Emergency Department at 
Hershey Medical Center. 
10.2
Clinical Covariates:  Detailed clinical covariates will be obtained from questionnaires and 
medical record review including demographics (age, gender, race), cancer type and stage, 
psychiatric history, chemotherapy regimen and medication use.  
10.3
Creative Workshop: Write from Heart: This workshop for cancer patients usually lasts one 
and a half hours and is broken into several parts. Usually beginning with inspirational quotes or 
passages from writings of respected authors, to shift mood and illuminated deeper thought and 
reflection. The next phase of the class consists of sharing a beautiful or whimsical object 
handed person to person or placed in the middle of the table to stimulate both curiosity and the 
senses. When participants are able to relax fully, in tranquil and focused surroundings the 
imagination easily transforms a bright polished stone or a glass heart with inner fractures into a 
metaphorical image. The technique of journaling is also encouraged in class, as a way to 
promote inner awareness to strengthen writing skills and to guide students to reach for their own 
comfort and consolation, when not in class. Within our setting, it is normal, though not 
mandatory that writing may lean toward the cancer experience. At the end of each series, 
students would have learned how to trust their artistic instincts, connect more courageously with 
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the world of their emotions and transform their fears and revelations about cancer into words on 
the page. 
10.4     Emotional Thermometers Scale: The Emotion Thermometers tool is a simple rapid modular 
screening tool for detection and monitoring of emotional disorders in clinical practice. It was 
created by Dr. Alex J Mitchell and has a simple visual-analogue design. It is easy for most 
patients (including older people) to understand, quick to administer and simple to score. We 
have already got permission from Dr. Alex J Mitchell for royalty free usage of this scale for 2 
years starting from Aug, 2016 till Aug 2018. We will be getting permission from him to extend 
the usage for an additional 1-2 years. 
10.5    Survey of Depression and Anxiety symptoms: For anxiety, we will use Generalized Anxiety  
Disorder 7-item (GAD-7) validated scale by Robert Spitzer et al. For depression we will use 
Patient Health Questionnaire 9–item (PHQ-9) validated scale by Robert Spitzer et al.  Both of 
these scales do not require any permission for reproduction, display, distribution or usage. 
10.6
Control group activities: Participants randomized into the control group were asked to 
maintain their usual follow up while also reading a book on creative writing for one and a half 
hours every other week for three months, logging their activity for verification of task completion.  
Their mode scores will be measured as mentioned above.
11.0
Statistical Plan
11.1
Statistical Analysis Plan
Participants’ basic demographic and baseline clinical measurements will be summarized using 
descriptive statistics. Those summarizations will be based on all patients as well as on patients 
within each group. This study has several main groups of outcome variables, which reflect several 
different domains of patient’s mental health. The first group is the emotion thermometer (which has 
five sub-scales), the second is the somatic symptom scale (SSS-8), the third is the Patient Health 
Questionnaire (PHQ-9), and the fourth is the Generalized Anxiety Disorder questionnaire (GAD-7), 
which measures participants’ anxiety. All the above outcome variable groups are based on 
questionnaires using Likert-scale questions to take the measurements, and each group may 
involve multiple sub-dimensions. Both the intervention group and the control group have repeated 
measures of the outcomes as shown in Figure 1. Graphical methods (such as the line plot of 
mean/SD values vs. time) will first be used to illustrate the mean and standard deviation values of 
the mode, depression, and anxiety scores through the time for both groups. These methods will 
help us detect the patterns of how the scores change over time (within-group change) and how the 
scores differ between groups. We will further use the linear mixed-effect model for repeated 
measures to analyze the within-group and between-group differences. Every sub-dimension will be 
analyzed individually, but we will also analyze the composite score for the dimensions. For the 
patients in the control group this study involves two stages (week 1-12 and week 13-20), and at the 
end of the 12th week, they can join the intervention group. This setting will allow us to study the 
effect of the intervention on the control group alone. For this part of analyses, linear mixed-effect 
models will be set up with the stage serves as an indicator variable in the model. The comparison 
of outcome variables between certain time points will also be done using paired tests. We will 
further investigate the possible factors that might affect the change of outcome variables over time. 
The factors are gender, race, marital status, time from cancer diagnosis (first 3 months, 3-6 
months, more than 6 months) and cancer stages. This part of analyses will mainly be focused on 
the intervention group and the above factors will be examined in the linear mixed-effect models. All 
analyses will be performed using statistical software SAS version 9.4 or higher (SAS Institute, 
Cary, NC, USA) and the statistical significance level to be used is 0.05.
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11.2
Sample size considerations:
We plan to enroll a total of 60 participants in the study – with 40 participants in the intervention 
group and 20 participants in the control group (2:1 ratio). This sample size is mainly determined by 
the capacity of the workshop. With this sample size we are able to detect a standard effect size 
(the mean difference measured in common standard deviation) of 0.45 with at least 80% statistical 
power (using two-sample repeated measure ANOVA model, assuming four time-points, and the 
within-patient auto-correlation being 0.2) . 
12.0
CONFIDENTIALITY
How will confidentiality of data be maintained?  Check all that apply.
 Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study.
 Use of a code number to label all research data
 Use of a study ID code linking list that will be maintained separate from the research data files 
on the HMC server (identifiers)
 Computer-based files will only be made available to personnel involved in the study through 
the use of access privileges and passwords.
 Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and confidentiality of identifiable information.
 Whenever feasible, identifiers will be removed from study-related information.
 A Certificate of Confidentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject’s financial standing, employability, 
or liability.
 A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
confidentiality.  (This is not an option for FDA-regulated research.) 
 Precautions are in place to ensure the data is secure by using passwords and encryption, 
because the research involves web-based surveys.  
 Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
 Other (specify): All data entered and stored in RedCap database (the proxy PI has an active 
RedCap account) and will be used to transfer data in a deidentified format only.
12.1
Identifiers associated with data and/or specimens
Identifiers like dates and medical record numbers will be used.
12.2
Use of Codes, Master List
Use of a code linking list will be maintained separate from the research data files on the 
HMC server.  All data entered and stored in HIPAA compliant RedCap database (the 
proxy PI has an active RedCap account) and will be used to transfer data in a deidentified 
format only.
12.3
Storage of Data 
All electronic files will be encrypted and/or password protected-EXCEL database, stored 
on a hard drive in locked HMC offices. Paper files will be stored in locked HMC offices/labs of 
the research team. These will be deleted/ shredded/destroyed at the end of study approval 
period. Information will be kept confidential and private and managed according to HIPAA 
guidelines.
12.4
Access to Data 
Research team consisting of PI, Co-investigators, team participants, biostatisticians only 
will have access to the data
12.5
Transferring Data
Not applicable.
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13.0
PRIVACY
Protected health information that will be obtained includes patient name, medical record number, and 
date of birth.  This information will be kept in a password-protected database in Excel sheet, behind the 
Pennsylvania State University firewall as well as the RedCAp database (Co-PI has an active RedCap account).  
Identifying information will be stored in a separate portion of the database, linked to the analytical database 
through an alphanumeric code.  Published data will only report aggregate, de-identified results.
14.0
DATA AND SAFETY MONITORING
All clinical information will be kept confidential, in a password-protected database or locked, secure 
location and managed according to HIPAA guidelines.  
14.1
Periodic evaluation of data 
Data evaluated at our site only. 
14.2
Data that are reviewed 
Data reviewed at our site only.
14.3
Method of collection of safety information
Data collected safely in a HIPAA compliant, encrypted database- Excel and REDCAP database. 
Access limited to PI and proxy PI and co-investigators only.
14.4
Frequency of data collection
Biweekly
14.5
Individual’s reviewing the data
PI, co-investigators, and statistician from our institution only
14.6
Frequency of review of cumulative data
Every month
14.7
Statistical tests
As mentioned in detail in statistics section
14.8
Suspension of research
Unable to do workshops.
14.9
Multi-center Research
Not applicable
15.0
RISK/BENEFIT ASSESSMENT
15.1
Potential Study Risks
Minimal. It is an intervention to determine changes in mood scales before and after creative 
writing workshop, and we anticipate minimal risk (breach of confidentiality – measures taken as above) for 
patients regarding their underlying cancer or treatment.
15.2
Potential Study Benefits
Participants randomized to the intervention with creative writing workshops may experience an 
improvement in their mood. We suspect that patients may have better adherence to their cancer therapy, but 
we do not expect any effect on cancer overall. 
  
15.3
Alternatives to Participation
Not participating.
16.0
SUBJECT COMPENSATION
No compensation will be provided. Coffee and light snacks will be served with every workshop.
17.0
NUMBER OF SUBJECTS: 60 
17.1
Intervention Arm: 
40
17.2
Control Arm:
20
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18.0
RESOURCES AVAILABLE
18.1
Facilities and locations
Only the patients seen at Penn State Hershey Cancer Institute will be included. PI has been 
involved in numerous previous studies at this location.
18.2
PI Time devoted to conducting the research
The PI will be devoted to conducting the research. The Co-PIs will have dedicated research 
time during their training to conduct the research. The study team will meet at biweekly intervals 
to review progress and provide feedback.
18.3
Availability of medical or psychological resources:
We will be collaborating with the Department of psychiatry at PSHMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who request psychiatry follow up will be 
referred to Dr. Joshi.
18.4
Process for informing Study Team
The study team will meet at biweekly intervals to review the progress of the study and to provide 
feedback.
19.0
ADVERSE EVENT REPORTING: 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
The only possible adverse event or unanticipated problem is the loss of confidentiality, and as far as 
loss of confidentiality is concerned, in accordance with applicable policies of The Pennsylvania State 
University Institutional Review Board (IRB), the investigator will report, to the IRB, any observed or 
reported harm (adverse event) experienced by a subject or other individual, which in the opinion of the 
investigator is determined to be (1) unexpected; and (2) probably related to the research procedures. 
Harms (adverse events) will be submitted to the IRB in accordance with the IRB policies and 
procedures.
20.0
STUDY MONITORING, AUDITING AND INSPECTING
The investigator will permit study-related monitoring, audits and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g. workshop room etc.).
21.0
REFERENCES:

Bolton G. (2008).”Writing is a way of saying things I can’t say”__ therapeutic creative writing: a 
qualitative study of its value to people with cancer cared for in cancer and palliative healthcare. Journal 
of Med Ethics; Medical Humanities, 34, 40-46.

Colleoni M, Mandala M, Peruzzotti G, et al. Depression and degree of acceptance of adjuvant cytotoxic 
drugs. Lancet. 2000;356:1326–1327. 

Esterling BA., L’Abate L., Murray EJ, et al. (1999). Empirical foundations for writing in prevention and 
psychotherapy: mental and physical health outcomes. Clinical Psychol Rev, 19, 79-96.

Gierk B, Kohlmann S, Kroenke K, et al. The Somatic Symptom Scale–8 (SSS-8). JAMA Intern Med. 
2014;174(3):399

Green A.R & Young R.A. (2015) The lived experience of visual creative expression for young adult 
cancer survivors. European Journal of Cancer Care 24, 695-706.  

Hass-Cohen N. (2008) CREATE: Art therapy relational neuroscience principals (ATR-N). In N. Hass-
Cohen & R.Carr (Eds), Art therapy and clinical neuroscience, London, UK: Jessica Kingsley Publishers.
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
Hunt, C. & Sampson, F.E. (Eds) (1998). The Self on the Page: Theory and Practice of Creative Writing 
in Personal Development. London: Jessica Kingsley. 

King, R., Neilson, P. & White, E. (2013). Creative writing in recovery from severe mental illness. 
International Journal of Mental Health Nursing, 22, 444-452.

Lao Tsu. Tao Te Ching (trans. Feng GF, English J). London: Wildwood House, 1973.

Lemon J, Edelman S, Kidman AD. Perceptions of the “Mind-Cancer” Relationship Among the Public, 
Cancer Patients, and Oncologists. J Psychosoc Oncol. 2004;21:43–58

Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: 
prevalence rates by cancer type, gender, and age. J Affect Disord. 2012;141:343–351

McLoughlin, D. (2004). Any-angles light: Diversity and inclusion through teaching poetry in health and 
social care. In: F. Sampson (Ed). Creative Writing in Health and Social Care. (pp.170-188). London: 
Jessica Kingsley.

Mishel MH, Hostetter T, King B, Graham V. Predictors of psychosocial adjustment in patients newly 
diagnosed with gynecological cancer. Cancer Nurs. 1984;7:291–299

Mitchell AJ, Baker-Glenn EA, Park B, Granger L, Symonds P. Can the Distress Thermometer be 
improved by additional mood domains? Part II. What is the optimal combination of Emotion 
Thermometers? Psychooncology. 2010 Feb;19(2):134-140 

Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by 
additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 
2010 Feb;19(2):125-33. 

Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 
2010;40:1797–1810. 

Roe, D. & Davidson, L. (2005). Self and narrative in schizophrenia: Time to author a new story. Medical 
Humanities, 31, 89-94

Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in 
cancer patients: a meta-analysis. Cancer. 2009;115:5349–536. 

Stanton AL, Danoff-Burg S, Sworowski LA, et al. Randomized, controlled trial of written emotional 
expression and benefit finding in breast cancer patients. J Clin Oncol. 2002;20(20):4160-4168

Stanton AL, Thompson EH, Crespi CM, Link JS, Waisman JR. Project connect online: randomized trial 
of an internet-based program to chronicle the cancer experience and facilitate communication. J Clin 
Oncol. 2013;31(27):3411-3417

Smyth, J.M. (1998). Written emotional expressions: Effect size, outcome types and moderating 
variables. Journal of Consulting and Clinical Psychology, 66(1), 174-184

Wright, J. & Chung, M.C. (2001). Mastery or mystery? Therapeutic writing: a review of the literature. 
British Journal of Guidance and Counselling, 29 (3), 277-291.
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22.0
TABLES and FIGURES for the STUDY
Table 1: DEMOGRAPHICS
Participant
1
2
3
4
5
6
7…
Serial Number
Alphaneumeric code
Medical Record Number
Gender
Age
Living Alone vs with 
family/caretaker
Primary Cancer Type
Cancer Stage
ECOG Performance Status
Enrolled in the Exercise 
Study
Regular exercise on or off 
the exercise study- >30mins 
three times a week
Current Treatment  
(Surgery, Radiation, Chemo) 
Disease status at 
completion of study (Stable, 
Progression, Remission)
Psychiatric history (previous 
diagnoses or 
hospitalizations)
Current Psychiatric 
Medications
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Figure 1: Emotion Thermometer Score (ETS)
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Figure 2: Somatic Symptom Scale
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Figure-3
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Figure - 4
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Dear Reviewers,
We wanted to bring your attention to 1 protocol change we have completed that we describe below.
1.
The Enrollment Period has been extended from 3 months to 4-5 months after initiation of study 
Rational: Difficulty with participant accrual. 
Our enrollment period is based on the last day individuals can enroll and still complete the requested 
number of classes. Previously, for a 6-month class schedule with a request for 3 months of participation, 
we would enroll for three months. By changing the requested participation to 2 classes/month in two 
months as described by the previous amendment, we can extend the enrollment period by two additional 
weeks while still having individuals be able to complete the necessary number of classes.  
Detailed description of changes
The following changes have been made in the document “HRP-591 Protocol for Human Subjects 
Research – Study 00008646 Creative Writing Study – IRB – Amendment 1 protocol v3 tracked edits 
8.30” – you can see these same changes on the Tracked Changes version of the protocol as well:
1) Section 9.2 Design, first paragraph, sentence 3 
- changed three to “four-month period”
2) Section 9.5 Study Schema, Figure 1: 
- edited study schema to reflect enrollment for 4-5 months 
3) Section 10.1 Methods 
- Changed enrollment from 1st 3 months to 1st 4-5 months 
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HRP-591 - Protocol for Human Subject Research 
Application for Review of Human Research: IRB Protocol Summary
Protocol Title: Effect of Group Led Creative Writing on Mood in Cancer Patients
Principal Investigator:
Name: Monika Joshi, MD, MRCP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: mjoshi@pennstatehealth.psu.edu
Co-Investigators: 
Name: Muhammad Hussain, MD (Co-PI)
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-0003 Ext:285177
E-mail Address: mhussain2@pennstatehealth.psu.edu
Name: Darya Nesterova, BS (Co-PI)
Department: College of Medicine
Telephone: 571-723-5722
Email: dnesterova@pennstatehealth.psu.edu
Name: Monali Vasekar, MD
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-8678
E-mail Address: mvasekar@pennstatehealth.psu.edu
 
Name: Jacqueline Heath, BS 
Department: College of Medicine
Telephone: 201-647-7084
Email: jheath2@pennstatehealth.psu.edu
Name: Joseph Drabick, MD FACP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: jdrabick@pennstatehealth.psu.edu
Name: Cristina Truica, MD
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: ctruica@pennstatehealth.psu.edu
 
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Name: Michael Hayes, Ph.D.
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-0003 Ext: 289370
E-mail Address: mhayes3@pennstatehealth.psu.edu
 
Biostatistician
Name: Junjia Zhu Ph.D.
Department: Public Health Services
Division: Biostatics
Telephone: 717-531-1509
E-mail Address: jzhu@phs.psu.edu
Collaborators:
Name: Aditya Joshi, MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-2947
E-mail Address: auj3@psu.edu
Name: Erika F.H Saunders MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531- 8516
E-mail Address:efs11@psu.edu
Version Date:
June 20th, 2018
Clinicaltrials.gov Registration #: N/A
If you need help…
University Park and other campuses:
Office for Research Protections Human Research Protection 
Program
The 330 Building, Suite 
205UniversityPark, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Hershey Medical Center:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building Room 1140)
Phone:717-531-5687
Fax number: 717-531-3937
Email: irb-hspo@psu.edu
Instructions for using this protocol template:
5.
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) in the “Basic 
Information” section. Links to Penn State’s protocol templates are available in the same location where 
they are uploaded, and their use is required.
6.
This template is provided to help investigators prepare a protocol that includes the necessary 
information needed by the IRB determine whether a study meets all criteria for approval. 
7.
There may be sections in this template that do not apply. If a section or question does not apply to the 
research study in question, provide the response “Not Applicable.”
8.
DO NOT TYPE IN THE GRAY BOXES.  All guidance language appears in gray boxes and these boxes 
MUST be deleted from the final version of the protocol prior to upload to CATS IRB.
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Table of Contents
1.0
PROTOCOL TITLE
2.0
STUDY SPONSORSHIP
3.0
PROTOCOL ABSTRACT
4.0
OBJECTIVES
5.0
BACKGRUND
8.0
RATIONALE AND HYPOTHESIS
9.0
CHARACTERISTICS OF STUDY POPULATION
7.1 TARGET POPULATION
7.2 ACCURAL
7.3 KEY INCLUSION CRITERIA
7.4 KEY EXCLUSION CRITERIA
7.5 VULNERABLE POPULATION
7.6 POPULATIONS VULNERABLE TO UNDUE INFLUENCE OR COERCION
7.7 SUBJECT RECRUITMENT
8.0
CONSENT PROCESS AND DOCUMENTATION
9.0
STUDY DESIGN
9.1 PHASE
9.2 DESIGN
9.3 DURATION
9.4 ENDPOINTS
9.5 STUDY SCHEMA
11.0
STUDY PROCEDURES
10.1 METHODS
10.2 CLINICAL COVARIATES
10.3 CREATIVE WORKSHOP
10.4 EMOTIONAL THERMOMETER SCALE
10.5 CONTROL GROUP ACTIVITES
11.0
STATISTICAL PLAN
12.0
CONFIDENTIALITY
13.0
PRIVACY
14.0
DATA AND SAFETY MONITORING
15.0
RISK/BENEFIT ASSESMENT
16.0
SUBJECT COMPENSATION
17.0
NUMBER OF SUBJECTS
18.0
RESOURCES AVAILABLE
19.0
ADVERSE EVENT REPORTING
20.0
STUDY MONITORING, AUDITING AND INSPECTING
21.0
REFERENCES
22.0
TABLES
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1.0
PROTOCOL TITLE
1.1
Effect of Group Led Creative Writing on Mood in Cancer patients.
1.2
Brief Title: Effect of Creative Writing on Mood in Cancer Patients.
2.0
STUDY SPONSORSHIP
2.1
Funding Sponsor:
Penn State Hershey Cancer Institute
Fifty Shades of Pink (Breast Cancer Endowment Fund)
2.2
Primary Sponsor:
Penn State Hershey Cancer Institute
3.0
PROTOCOL ABSTRACT
The primary purpose of this study is to determine whether creative writing in newly diagnosed cancer 
patients and those with recent progression in their disease will have a positive impact on their mental 
health. Using a randomized controlled trial approach, emotion thermometers will be employed to 
evaluate participants’ responses on a number of domains, such as anxiety, depression, despair, and 
anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. 
Open-ended survey questions will be used to capture how a creative writing intervention impacts 
participants’ experience of their illness. Melissa Greene’s Write from the Heart program focuses more 
on creative writing rather than cancer focused topics. Patients in the intervention arm will complete –
one and a half hour group sessions every two weeks over the span of 3 months. Participants in the 
active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg) about 
creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a period of 2-3 months.
4.0
OBJECTIVES
4.1
Primary Objectives:  

Mental wellness before and after intervention in the intervention and control groups. A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
reflecting participants’ mental health pre- and post-intervention. Survey questions 
focused on symptoms of depression and anxiety will be used to monitor for changes in 
mental wellness pre- and post-intervention. 
4.2
Secondary Objectives: 

Comparison of mood scores, depression and anxiety symptoms versus frequency of 
attendance in the intervention arm. 

Comparison of somatic symptom burden between intervention and control group.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms after workshop between genders. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between patients living alone versus with family.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between various cancer types.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who have previously attended a creative writing class versus 
those who have not. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who completed control group activity and then enrolled in the 
workshops and attended at least one session. 

Comparison of the frequency of emergency room visits and hospitalizations between 
intervention and control group during the study period.
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
Comparison of cancer status (stable, progressing, in remission) between intervention 
and control group.
5.0
BACKGROUND
5.1 Scientific Background and Gaps 
Cancer is a life-threatening, feared diagnosis and is a source of great distress in patients. Hence in 
addition to treating cancer, one must address the emotional well-being of patients. 
Creative activity has a significant history in providing a wide range of psychological and 
physiological benefits for cancer survivors (King et al., 2012). When individuals experience a stressful 
life event or crisis, the higher verbal functions in the cerebral cortex become less accessible (Hass-
Cohen, 2008.) Therefore, patients who face such stressful life events of cancer are often left without 
words to describe their experiences of feelings (Green & Young, 2015). Findings from Green and 
Young (2015) suggest that creative visual expression, engaging both in an individual and the 
therapeutic setting, offered an opportunity for young adult survivors to express their emotions from 
deep within their bodies. It created self-understanding and a sense of healing. 
In another study by Bolton (2007) patients indicated that they found the therapeutic writing process 
beneficial. For example, one participant narrated, “It made it less traumatic than it might have been 
otherwise.” Creative writing has been recognized to explore and express personal thoughts, feelings, 
and experiences. Lau Tsu (1973) showed that writing facilitated patients’ ability to discover what they 
thought felt and remembered. Therapeutic creative writing enhanced their awareness of and ability to 
express issues to which attention and focus are required. (Esterhing BA et al., 1999)
There is a substantial area of agreement that language, narrative storytelling, forms an essential 
element in the construction of a coherent identity, sense of self and connectedness to others, and 
therefore, it is a powerful tool in creative therapy (Smyth, 1998; Wright & Chung, 2001). Roe and 
Davidson (2005) argue that processes of re-authoring one’s life story are actually integral components 
of the recovery process itself. A study by Stanton (2002) of breast cancer patients prompted to write 
about their cancer experience showed a significant decrease in self-reported somatic symptoms and 
medical appointment visits for cancer-related morbidities three months after participation in the study. A 
follow-up study by Stanton (2013) encouraged breast cancer patients to create personal websites to 
chronicle their experience and to communicate with their social network. This study showed significant 
improvement in positive mood and depressive symptoms after 6 months, particularly in patients 
undergoing medical therapy at that time.  These studies further support that the act of narrative story 
telling can improve patient wellbeing. 
Furthermore, King et al. (2012) suggest that writing can contribute to repair of symbolic functioning 
and contribute to the development of personal identity. The researchers concluded that, of all the 
creative arts, writing is least dependent on equipment and/or special environments. Writing workshops 
are probably better provided by professional writers than by mental health professionals. When health 
professionals provide activities such as a writing workshop, there is a risk that identification with the 
illness is reinforced. On the other hand, when a professional writer provides a similar activity, it is the 
participant’s identity as a writer that is reinforced, rather than their identity as a person with an illness. 
(King et al., 2012)
Moreover, there is emerging consensus in the UK and USA that there might be advantages if 
writing therapy is received from facilitators who themselves are trained writers and can work in 
collaboration with health care professionals. (Hunt & Sampson, 1998; Mc Loughlin, 2004).
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  5.2   Previous Data 
We conducted a pilot study to determine feasibility whether cancer patients can be enrolled, 
randomized and retained for four weeks for creative writing classes (Feasibility was defined as 50% of 
our enrolled patients on intervention arm (IA) could attend at least 2 classes). We anticipated enrolling 
45 patients over the period of 2 months with randomization into 2 arms: IA and standard of care (SOC). 
“Write from the Heart” a series of creative writing workshops (CWW) were conducted on IA. Subjects in 
IA had four, 2-hour weekly CWW whereas SOC arm did not receive any session. We used validated 
Emotional Thermometer Scales (ETS), ranging 0 (best)-10 (worst), to predict changes in a number of 
parameters reflecting patient’s mental health pre and post intervention. ETS has five dimensions 
(distress, anxiety, depression, anger and need help), which are all continuous variables.  Due to time 
constraints we were not able to accrue the desired number of patients. A total of 16 patients were 
accrued in 1 month period -11 in IA and 5 in SOC. 7 out of 11 (63%) patients enrolled in IA attended at 
least 75% of classes. Comparisons were made using two-sample T-tests. Although sample size was 
small, IA did show a decreasing pattern on Total Emotion Score (TES), particularly in depression and 
anxiety scores (See table 1 and figure 1, 2). For each visit, post-class scores were lower than pre-class 
scores. We observed that it is feasible for cancer patients to attend focused workshops geared towards 
mental health wellbeing. IA showed a trend towards mood improvement, although was not shown to be 
statistically significant which may be attributed to the small sample size. Having shown the feasibility of 
such a study, we hope to increase the sample size and include more specific methods for quantifying 
mood improvement in the patient groups. In addition, after reviewing the suggestions (post completion 
of the study) from the patients who attended these sessions on the study, we concluded that 1.5hours 
of class twice a month is feasible and helpful for patients. 
Table 1: Mean and Median TES at baseline and after intervention in SOC versus IA.
Fig 1: Total Emotions Scores before and after each 
visit.
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Fig 2, A-D: Emotions Scores before and after each visit; A-D: A-Distress, B-Depression, C-Anxiety, D- Anger
6.0
RATIONALE AND HYPOTHESIS
6.1
RATIONALE:
Cancer generates an increased sense of distress than non-malignant diseases with poor 
prognoses (Mishel et al., 1984). Persistent mental distress for prolonged periods leads to anxiety and 
depression. The rate of depression in cancer patients is thought to be up to three times higher than in 
the general population (Linden et al., 2012). Depression leads to a poorer quality of life (QOL) and 
affects patient outcomes, with depression resulting in higher rates of mortality in cancer (Colleoni et al., 
2000, Pinquart et al., 2010). A meta-analysis revealed that minor or major depression increases 
mortality rates by up to 39%, and that patients displaying even few depressive symptoms may be at a 
25% increased risk of mortality (Satin et al., 2009). The impact of mood and mental wellbeing on cancer 
progression is considered important by doctors and patients, with >70% of oncologists and 85% of 
patients believing that mood affects the progression of cancer (Lemon et al., 2004). Our previous data 
as mentioned before shows that creative writing is feasible and needs to be further studied to 
understand the effect of group therapy with focused workshop in newly diagnosed or patients with 
recent recurrence. In addition, we observed that the emotional thermometer scale was not enough to 
capture the mood of the patients. For example, some patients felt significantly better after attending 
these sessions and were able to cope with their symptoms but the emotional scale did not reflect that 
benefit. 
6.2
HYPOTHESIS:
This study aims to look at the impact of participating in creative writing workshop group Write 
from the Heart, on cancer patients’ emotional well-being. Keeping previous studies in mind, a 
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professional writer will conduct the workshops, which will enhance the participant’s ability to express 
and enhance their awareness. We anticipate that participation in the workshop will result in a positive 
effect on the parameters being studied, enabling patients to cope with their illness/cancer better.  We 
hypothesize that group sessions of creative writing workshop could be better than individual sessions. 
7.0
CHARACTERISTICS OF THE STUDY POPULATION
7.1
Target Population
Adults with a new diagnosis of cancer, at any stage OR progression of  
cancer- within three months of enrollment.   
7.2
Accrual
We aim to accrue 60 eligible patients over a time span of 4months at the Milton S. Hershey 
Medical Center.
7.3
Key Inclusion Criteria

Adult >20 years of age 

Any patient with a cancer diagnosis. 

Ability to understand English language and ability to write without any functional difficulty

ECOG performance status 0-3
7.4
Key Exclusion Criteria 

Inability to give informed consent

Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis) 

Severe cognitive impairment

Pregnant females

Inability to write or understand English
7.5
Vulnerable Populations 
None
7.6
Populations vulnerable to undue influence or coercion
If a patient who works for or has some affiliation to Pennsylvania State University happens to be 
in the potential participant pool, we will verbally stress to him/her that their participation is 
voluntary and will not influence her care or any outcomes related to Penn State. 
7.7
Subject Recruitment 
We will recruit participants from our outpatient cancer clinics at HMC (Hershey Medical Center). 
We will create a pamphlet describing our study briefly and study staff contacts, then distribute in 
all cancer clinics. This will be given to every cancer patient at any stage, with recurrence, or with 
progression at HMC. We will also send emails to physicians and nurses at outpatient cancer 
clinics at HMC for study description and our contact details. If patients are interested, we (study 
staff) will conduct initial eligibility screening and obtain informed consent from patients to initiate 
study follows up. 
9.0
CONSENT PROCESS AND DOCUMENTATION
9.1
Consent Process
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9.1.1
Obtaining Informed Consent
Physician-Investigators of the study will identify patients from their clinic and 
patients will be approached to participate in the study. Study staff will then discuss the study in 
detail to make the patient aware of the workshops, intervention, and time commitment involved 
with the study. If the patient is interested, study staff will answer any remaining questions and 
obtain written informed consent at the patient’s clinic visit with their primary oncologist.
8.1.2
Coercion or Undue Influence during Consent
If a patient affiliated with Pennsylvania State University happens to be in the potential 
participant pool, we will inform them that their participation is voluntary and will not influence her 
care or any outcomes related to Penn State. 
8.1.3  Waiver of Authorization
Not applicable
8.4
Consent Documentation
8.4.1
Written Documentation of Consent
Study staff members will assist with data and consent collection. If the patients are unable or not 
competent to give consent, they will not be enrolled in the study.
8.5
Consent – Other Considerations 
8.5.1.1 Non-English Speaking Subjects
Not included.
8.5.1.2 Cognitively Impaired Adults
Not included.
8.5.1.3 Subjects who are not yet adults (i.e., infants, children, teenagers) 
Inclusion criteria: greater than 20 years of age
9.0
STUDY DESIGN
  
9.1
Phase
Phase II
9.2
Design
The focus of this study is to determine the difference in mental health parameters following the 
participation of cancer patients in a creative writing workshop. Participants will be randomized 
within strata formed by cancer type in order to assure that these potentially important 
confounding variables are balanced across groups. Patients will be enrolled on a rolling basis 
over a four to five-month period, allowing patients in intervention arm to participate in 2-3 
months workshops (workshops would be held once every 2 weeks). Patients in control arm will 
be provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be 
asked to do activities for 1.5 hours every 2 weeks. After three months, control group participants 
can join creative writing workshops at their discretion for the remaining period for writing 
workshops. Both group members will receive follow up surveys twice a month for two months at 
the completion of the participant’s three-month study period.  
9.3
Study Duration 
Estimated time to enroll all subjects = 3-5 months (Patients will start being enrolled after IRB 
approval and we will continue the enrollment up to 4-5 months from the time the 1st class starts 
for 
the intervention group)
Length of a participant's participation = 2 - 6 months; Follow up after participant’s completion of 
classes = 2 months 
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9.4
Endpoints:
9.4.1
Primary endpoints: 

Mood scores before (at baseline) and after intervention (after completion of entire 
sessions - this may vary as some patients may not be able to complete six sessions). A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
pre and post-intervention.

Severity of depression and anxiety symptoms before and after intervention between two 
groups. Validated Depression and Anxiety questionnaires will be used to predict 
changes, the PHQ-9 and GAD-7 respectively. 
9.4.2
Secondary endpoints: 

Mood and symptoms before and after at least 2 sessions of intervention. 

Self-reported somatic symptoms pre and post intervention in two groups. We will use the 
Somatic Symptom Scale – 8 (SSM-8) to quantify somatic symptom burden. 

Difference in scores and symptoms between various genders.

Difference in scores and symptoms between patients living alone versus with family.

Difference in scores and symptoms in different cancer types.  

Difference in scores and symptoms versus number of classes attended. 

Differences between individual mood scores for patients in the control group who later 
switch to intervention group and attend at least one session

Mood and symptom scores up to 2 months after completion of the study. 
9.4.3    Exploratory endpoints

Difference in number of emergency room visits and hospitalizations during study period 
between control and intervention group. 

Comparison of status of cancer (stable, progressing, in remission) between intervention 
and control group.
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9.5
Study Schema
                        Figure 1:
Enrollment in clinic 
setting
Intervention n= 40
1.5 hours  twice a month 
(every other week or per 
patient's convenience) 
with Melissa Greene for 2 
months 
Rolling enrollment  during 
first 4.5 months  of the 6 
month workshop series with 
the intention that patients 
enrolled can attend 2 
consecutive months
Control n= 20
Receive Creative Writing 
workbook to do for 1.5 
hours every other week for 
2-3 consecutive months
Patients who complete 
control criteria during first 
2-3 months or more are 
given the opportunity to 
join intervention arm for 
the remainder of the study 
duration- their individual 
data will be collected and 
compared to their previous
All patients would be 
followed for 2 months post 
completion of their 
assigned initial 2-3 month 
clasess
Patient population
N=60
Inclusion criteria: 
-Any patient with a cancer 
diagnosis.
-Ability to understand English 
language and ability to write 
without any functional difficulty
-ECOG performance status 0-3
Primary end points:
1. Mood scores
2. Depression and Anxiety scores 
10.0
STUDY PROCEDURES
10.1
Methods:   After enrollment as above, co-investigators of this study or the assigned 
coordinator will be doing the consent. Patient will be randomized to intervention and control 
arms in a 2:1 ratio. The intervention arm will receive a dedicated workshop for one and a half 
hours every 2 weeks.  We aim to start a 6 month long program with weekly creative writings 
workshops, and patient enrollment in the study will continue through the 1st 4.5 months of the 6 
month period so that the last enrolled patient could complete 2 classes per month for two 
months. Each patient will be asked to attend at least two classes per month for a total of two 
months. These workshops will be held at Hershey Medical Center (HMC). At the initiation of the 
study along with consent we will collect baseline scores in both groups for each parameter as 
below. Somatic Symptom Burden (SSM-8 - Figure 2 - reference section), depression symptoms 
using PHQ-9 (Figure 3 – reference section), and anxiety symptoms using GAD-7 (Figure 4 –
reference section) will be collected monthly and following intervention completion. 
We will collect mood scores pre and post each session. We will use Emotional Thermometer 
Scale (EMS) from Dr. Alex J. Mitchell (Feb. 2010), diagram for scales is shown in figure 1. 
Please see supplementary index for a letter of permission to use from Dr. Mitchell. We will give 
the Thermometer scales and collect scores pre and post each session and also collect scores 
pre and post completion of entire course. Control group will do EMS on monthly basis along with 
other parameters. At the end of the study we will review all participants’ medical charts to count 
view the number of emergency room visits and hospitalizations each participant experienced 
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during the study period. These will be further broken down in categories based on cancer 
related vs non-cancer related visits.  We will also review their most current cancer disease 
status after completion of the workshops and categorize whether their status is considered to be 
stable, progressing, or in remission. Both groups will also receive follow up mood and symptom 
surveys twice a month for up to 2 months after completion of the participant’s two to three 
month study period. 
The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative 
writing and asked to read and do writing activities for one and a half hours once every two 
weeks. At the completion of the two-month participation or completion of 4 sessions control 
patients will be given the opportunity to enroll in the creative writing workshops for the 
remainder of the study period of 6 months. We will collect scores from control arm through the 
same Emotion Thermometers Scale on a monthly basis. Pre-intervention scores will be 
obtained at the time of consent or one week prior to the planned start of session 1 for workshop 
(either in the clinic if possible or mail the score sheet to patients with an enclosed stamped 
envelope for return of the scales). Depending on participant preference, we can send them 
emails of the REDCAP surveys containing the same information at set intervals. A sample of the 
REDCAP surveys is included in supplementary materials. We will also send participants in the 
control arm a stamped return envelope on a monthly basis if not able to get score sheets in a 
clinic or over REDCAP, depending on patient convenience and preference. We will call the 
participants once every 3-4 weeks to check in on their progress. Please see a calendar at the 
end for details. 
To assess for possible confounding results of patients participating in the concurrent exercise 
study, we will ask participants if they are also enrolled in the exercise study at enrollment and 
perform a subset analysis for patients who are in the exercise study. They will be randomized 
into either control or intervention group in the same manner as the other patients in the study. 
We will additionally include a section of the survey to ask about regular exercise (more than 30 
minutes, three times a week) and do a subset analysis of these patients as well.   
 
We will be collaborating with the Department of psychiatry at HMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who requests psychiatry follow up will be 
referred to Dr. Michael Hayes.  If participants report the presence of suicidal ideation per 
question nine on the PHQ-9 [i.e., Thoughts that you would be better off dead or of hurting 
yourself in some way], they will be referred on an urgent basis to Dr. Michael Hayes or Dr. 
Aditya Joshi. In the event Dr. Hayes and/or Dr. Joshi are unavailable for follow-up,  If any active 
suicidal thoughts are reported, participants will be referred directly to Emergency Department at 
Hershey Medical Center. 
10.2
Clinical Covariates:  Detailed clinical covariates will be obtained from questionnaires and 
medical record review including demographics (age, gender, race), cancer type and stage, 
psychiatric history, chemotherapy regimen and medication use.  
10.3
Creative Workshop: Write from Heart: This workshop for cancer patients usually lasts one 
and a half hours and is broken into several parts. Usually beginning with inspirational quotes or 
passages from writings of respected authors, to shift mood and illuminated deeper thought and 
reflection. The next phase of the class consists of sharing a beautiful or whimsical object 
handed person to person or placed in the middle of the table to stimulate both curiosity and the 
senses. When participants are able to relax fully, in tranquil and focused surroundings the 
imagination easily transforms a bright polished stone or a glass heart with inner fractures into a 
metaphorical image. The technique of journaling is also encouraged in class, as a way to 
promote inner awareness to strengthen writing skills and to guide students to reach for their own 
comfort and consolation, when not in class. Within our setting, it is normal, though not 
mandatory that writing may lean toward the cancer experience. At the end of each series, 
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students would have learned how to trust their artistic instincts, connect more courageously with 
the world of their emotions and transform their fears and revelations about cancer into words on 
the page. 
10.4     Emotional Thermometers Scale: The Emotion Thermometers tool is a simple rapid modular 
screening tool for detection and monitoring of emotional disorders in clinical practice. It was 
created by Dr. Alex J Mitchell and has a simple visual-analogue design. It is easy for most 
patients (including older people) to understand, quick to administer and simple to score. We 
have already got permission from Dr. Alex J Mitchell for royalty free usage of this scale for 2 
years starting from Aug, 2016 till Aug 2018. We will be getting permission from him to extend 
the usage for an additional 1-2 years. 
10.5    Survey of Depression and Anxiety symptoms: For anxiety, we will use Generalized Anxiety  
Disorder 7-item (GAD-7) validated scale by Robert Spitzer et al. For depression we will use 
Patient Health Questionnaire 9–item (PHQ-9) validated scale by Robert Spitzer et al.  Both of 
these scales do not require any permission for reproduction, display, distribution or usage. 
10.6
Control group activities: Participants randomized into the control group were asked to 
maintain their usual follow up while also reading a book on creative writing for one and a half 
hours every other week for three months, logging their activity for verification of task completion.  
Their mode scores will be measured as mentioned above.
12.0
Statistical Plan
12.1
Statistical Analysis Plan
Participants’ basic demographic and baseline clinical measurements will be summarized using 
descriptive statistics. Those summarizations will be based on all patients as well as on patients 
within each group. This study has several main groups of outcome variables, which reflect several 
different domains of patient’s mental health. The first group is the emotion thermometer (which has 
five sub-scales), the second is the somatic symptom scale (SSS-8), the third is the Patient Health 
Questionnaire (PHQ-9), and the fourth is the Generalized Anxiety Disorder questionnaire (GAD-7), 
which measures participants’ anxiety. All the above outcome variable groups are based on 
questionnaires using Likert-scale questions to take the measurements, and each group may 
involve multiple sub-dimensions. Both the intervention group and the control group have repeated 
measures of the outcomes as shown in Figure 1. Graphical methods (such as the line plot of 
mean/SD values vs. time) will first be used to illustrate the mean and standard deviation values of 
the mode, depression, and anxiety scores through the time for both groups. These methods will 
help us detect the patterns of how the scores change over time (within-group change) and how the 
scores differ between groups. We will further use the linear mixed-effect model for repeated 
measures to analyze the within-group and between-group differences. Every sub-dimension will be 
analyzed individually, but we will also analyze the composite score for the dimensions. For the 
patients in the control group this study involves two stages (week 1-12 and week 13-20), and at the 
end of the 12th week, they can join the intervention group. This setting will allow us to study the 
effect of the intervention on the control group alone. For this part of analyses, linear mixed-effect 
models will be set up with the stage serves as an indicator variable in the model. The comparison 
of outcome variables between certain time points will also be done using paired tests. We will 
further investigate the possible factors that might affect the change of outcome variables over time. 
The factors are gender, race, marital status, time from cancer diagnosis (first 3 months, 3-6 
months, more than 6 months) and cancer stages. This part of analyses will mainly be focused on 
the intervention group and the above factors will be examined in the linear mixed-effect models. All 
analyses will be performed using statistical software SAS version 9.4 or higher (SAS Institute, 
Cary, NC, USA) and the statistical significance level to be used is 0.05.
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12.2
Sample size considerations:
We plan to enroll a total of 60 participants in the study – with 40 participants in the intervention 
group and 20 participants in the control group (2:1 ratio). This sample size is mainly determined by 
the capacity of the workshop. With this sample size we are able to detect a standard effect size 
(the mean difference measured in common standard deviation) of 0.45 with at least 80% statistical 
power (using two-sample repeated measure ANOVA model, assuming four time-points, and the 
within-patient auto-correlation being 0.2) . 
12.0
CONFIDENTIALITY
How will confidentiality of data be maintained?  Check all that apply.
 Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study.
 Use of a code number to label all research data
 Use of a study ID code linking list that will be maintained separate from the research data files 
on the HMC server (identifiers)
 Computer-based files will only be made available to personnel involved in the study through 
the use of access privileges and passwords.
 Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and confidentiality of identifiable information.
 Whenever feasible, identifiers will be removed from study-related information.
 A Certificate of Confidentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject’s financial standing, employability, 
or liability.
 A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
confidentiality.  (This is not an option for FDA-regulated research.) 
 Precautions are in place to ensure the data is secure by using passwords and encryption, 
because the research involves web-based surveys.  
 Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
 Other (specify): All data entered and stored in RedCap database (the proxy PI has an active 
RedCap account) and will be used to transfer data in a deidentified format only.
12.6
Identifiers associated with data and/or specimens
Identifiers like dates and medical record numbers will be used.
12.7
Use of Codes, Master List
Use of a code linking list will be maintained separate from the research data files on the 
HMC server.  All data entered and stored in HIPAA compliant RedCap database (the 
proxy PI has an active RedCap account) and will be used to transfer data in a deidentified 
format only.
12.8
Storage of Data 
All electronic files will be encrypted and/or password protected-EXCEL database, stored 
on a hard drive in locked HMC offices. Paper files will be stored in locked HMC offices/labs of 
the research team. These will be deleted/ shredded/destroyed at the end of study approval 
period. Information will be kept confidential and private and managed according to HIPAA 
guidelines.
12.9
Access to Data 
Research team consisting of PI, Co-investigators, team participants, biostatisticians only 
will have access to the data
12.10 Transferring Data
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Not applicable.
13.0
PRIVACY
Protected health information that will be obtained includes patient name, medical record number, and 
date of birth.  This information will be kept in a password-protected database in Excel sheet, behind the 
Pennsylvania State University firewall as well as the RedCAp database (Co-PI has an active RedCap account).  
Identifying information will be stored in a separate portion of the database, linked to the analytical database 
through an alphanumeric code.  Published data will only report aggregate, de-identified results.
14.0
DATA AND SAFETY MONITORING
All clinical information will be kept confidential, in a password-protected database or locked, secure 
location and managed according to HIPAA guidelines.  
14.9
Periodic evaluation of data 
Data evaluated at our site only. 
14.10 Data that are reviewed 
Data reviewed at our site only.
14.11 Method of collection of safety information
Data collected safely in a HIPAA compliant, encrypted database- Excel and REDCAP database. 
Access limited to PI and proxy PI and co-investigators only.
14.12 Frequency of data collection
Biweekly
14.13 Individual’s reviewing the data
PI, co-investigators, and statistician from our institution only
14.14 Frequency of review of cumulative data
Every month
14.15 Statistical tests
As mentioned in detail in statistics section
14.16 Suspension of research
Unable to do workshops.
14.9
Multi-center Research
Not applicable
15.0
RISK/BENEFIT ASSESSMENT
15.1
Potential Study Risks
Minimal. It is an intervention to determine changes in mood scales before and after creative 
writing workshop, and we anticipate minimal risk (breach of confidentiality – measures taken as above) for 
patients regarding their underlying cancer or treatment.
15.2
Potential Study Benefits
Participants randomized to the intervention with creative writing workshops may experience an 
improvement in their mood. We suspect that patients may have better adherence to their cancer therapy, but 
we do not expect any effect on cancer overall. 
  
15.3
Alternatives to Participation
Not participating.
16.0
SUBJECT COMPENSATION
No compensation will be provided. Coffee and light snacks will be served with every workshop.
17.0
NUMBER OF SUBJECTS: 60 
17.1
Intervention Arm: 
40
17.3
Control Arm:
20
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21.0
RESOURCES AVAILABLE
18.1
Facilities and locations
Only the patients seen at Penn State Hershey Cancer Institute will be included. PI has been 
involved in numerous previous studies at this location.
18.5
PI Time devoted to conducting the research
The PI will be devoted to conducting the research. The Co-PIs will have dedicated research 
time during their training to conduct the research. The study team will meet at biweekly intervals 
to review progress and provide feedback.
18.6
Availability of medical or psychological resources:
We will be collaborating with the Department of psychiatry at PSHMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who request psychiatry follow up will be 
referred to Dr. Joshi.
18.7
Process for informing Study Team
The study team will meet at biweekly intervals to review the progress of the study and to provide 
feedback.
22.0
ADVERSE EVENT REPORTING: 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
The only possible adverse event or unanticipated problem is the loss of confidentiality, and as far as 
loss of confidentiality is concerned, in accordance with applicable policies of The Pennsylvania State 
University Institutional Review Board (IRB), the investigator will report, to the IRB, any observed or 
reported harm (adverse event) experienced by a subject or other individual, which in the opinion of the 
investigator is determined to be (1) unexpected; and (2) probably related to the research procedures. 
Harms (adverse events) will be submitted to the IRB in accordance with the IRB policies and 
procedures.
23.0
STUDY MONITORING, AUDITING AND INSPECTING
The investigator will permit study-related monitoring, audits and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g. workshop room etc.).
21.0
REFERENCES:

Bolton G. (2008).”Writing is a way of saying things I can’t say”__ therapeutic creative writing: a 
qualitative study of its value to people with cancer cared for in cancer and palliative healthcare. Journal 
of Med Ethics; Medical Humanities, 34, 40-46.

Colleoni M, Mandala M, Peruzzotti G, et al. Depression and degree of acceptance of adjuvant cytotoxic 
drugs. Lancet. 2000;356:1326–1327. 

Esterling BA., L’Abate L., Murray EJ, et al. (1999). Empirical foundations for writing in prevention and 
psychotherapy: mental and physical health outcomes. Clinical Psychol Rev, 19, 79-96.

Gierk B, Kohlmann S, Kroenke K, et al. The Somatic Symptom Scale–8 (SSS-8). JAMA Intern Med. 
2014;174(3):399

Green A.R & Young R.A. (2015) The lived experience of visual creative expression for young adult 
cancer survivors. European Journal of Cancer Care 24, 695-706.  

Hass-Cohen N. (2008) CREATE: Art therapy relational neuroscience principals (ATR-N). In N. Hass-
Cohen & R.Carr (Eds), Art therapy and clinical neuroscience, London, UK: Jessica Kingsley Publishers.
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
Hunt, C. & Sampson, F.E. (Eds) (1998). The Self on the Page: Theory and Practice of Creative Writing 
in Personal Development. London: Jessica Kingsley. 

King, R., Neilson, P. & White, E. (2013). Creative writing in recovery from severe mental illness. 
International Journal of Mental Health Nursing, 22, 444-452.

Lao Tsu. Tao Te Ching (trans. Feng GF, English J). London: Wildwood House, 1973.

Lemon J, Edelman S, Kidman AD. Perceptions of the “Mind-Cancer” Relationship Among the Public, 
Cancer Patients, and Oncologists. J Psychosoc Oncol. 2004;21:43–58

Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: 
prevalence rates by cancer type, gender, and age. J Affect Disord. 2012;141:343–351

McLoughlin, D. (2004). Any-angles light: Diversity and inclusion through teaching poetry in health and 
social care. In: F. Sampson (Ed). Creative Writing in Health and Social Care. (pp.170-188). London: 
Jessica Kingsley.

Mishel MH, Hostetter T, King B, Graham V. Predictors of psychosocial adjustment in patients newly 
diagnosed with gynecological cancer. Cancer Nurs. 1984;7:291–299

Mitchell AJ, Baker-Glenn EA, Park B, Granger L, Symonds P. Can the Distress Thermometer be 
improved by additional mood domains? Part II. What is the optimal combination of Emotion 
Thermometers? Psychooncology. 2010 Feb;19(2):134-140 

Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by 
additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 
2010 Feb;19(2):125-33. 

Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 
2010;40:1797–1810. 

Roe, D. & Davidson, L. (2005). Self and narrative in schizophrenia: Time to author a new story. Medical 
Humanities, 31, 89-94

Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in 
cancer patients: a meta-analysis. Cancer. 2009;115:5349–536. 

Stanton AL, Danoff-Burg S, Sworowski LA, et al. Randomized, controlled trial of written emotional 
expression and benefit finding in breast cancer patients. J Clin Oncol. 2002;20(20):4160-4168

Stanton AL, Thompson EH, Crespi CM, Link JS, Waisman JR. Project connect online: randomized trial 
of an internet-based program to chronicle the cancer experience and facilitate communication. J Clin 
Oncol. 2013;31(27):3411-3417

Smyth, J.M. (1998). Written emotional expressions: Effect size, outcome types and moderating 
variables. Journal of Consulting and Clinical Psychology, 66(1), 174-184

Wright, J. & Chung, M.C. (2001). Mastery or mystery? Therapeutic writing: a review of the literature. 
British Journal of Guidance and Counselling, 29 (3), 277-291.
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22.0
TABLES and FIGURES for the STUDY
Table 1: DEMOGRAPHICS
Participant
1
2
3
4
5
6
7…
Serial Number
Alphaneumeric code
Medical Record Number
Gender
Age
Living Alone vs with 
family/caretaker
Primary Cancer Type
Cancer Stage
ECOG Performance Status
Enrolled in the Exercise 
Study
Regular exercise on or off 
the exercise study- >30mins 
three times a week
Current Treatment  
(Surgery, Radiation, Chemo) 
Disease status at 
completion of study (Stable, 
Progression, Remission)
Psychiatric history (previous 
diagnoses or 
hospitalizations)
Current Psychiatric 
Medications
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Figure 1: Emotion Thermometer Score (ETS)
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Figure 2: Somatic Symptom Scale
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Figure-3
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Figure - 4
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Dear Reviewers,
We wanted to bring your attention to 3 protocol changes we have completed that we describe below.
2.
Eligibility criteria has been changed from cancer patients with new diagnosis or progression in the last 
three months from consent, to any patient with a cancer diagnosis. 
Rational: Difficulty with participant accrual. 
Although patients with new diagnosis or recent progression were originally chosen for this study due to our 
belief that they would most benefit from this intervention, we have found that after a month and a half of 
recruitment, we have only been able to recruit 15 out of our goal of 60 patients. We are concerned that we 
will not be able to meet our enrollment goal and thus want to expand to more patients. We believe that 
time from diagnosis is an important factor and will thus do a subset analysis at the completion of the study 
stratifying by time since diagnosis at enrollment (less than 3 months, 3-6 months, more than 6 months) to 
ensure that we still capture that information. We found that many individuals who we approached felt very 
overwhelmed by their diagnosis and frequency of other visits necessary for initial treatment of the 
diagnosis and were reluctant to add on another commitment. By expanding to patients further along from 
their diagnosis, we hope to be able to increase our study enrollment. 
3.
Number of classes patients are asked to attend has been decreased from 6 classes over 3 months to 4 
classes over two months. 
Rational: Difficulty with participant accrual. 
In addition to the above stated reason, we found many individuals expressing reluctance to join the study 
due to concerns about the prolonged commitment to attending classes for three months. We felt that by 
decreasing the number to four sessions over the span of two months, attending 2 sessions per month, as 
opposed to six sessions, every other week over three months, may help us engage more participants, 
allowing them more flexibility with their schedule, particularly during the summer months when many 
individuals have vacation plans. Subsequently, we have noticed that once individuals start attending the 
sessions, they greatly enjoy them and want to continue, thus we believe that despite hanging the minimum 
number of classes we request participants attend, we may still be able to collect data for individual 
patients beyond 2 months. 
4.
The Enrollment Period has been extended from 3 months to 4 months after initiation of study to comply 
with change in number of classes requested from participants. 
Rational: Difficulty with participant accrual. 
Our enrollment period is based on the last day individuals can enroll and still complete the requested 
number of classes. Previously, for a 6-month class schedule with a request for 3 months of participation, 
we would enroll for three months. By changing the requested participation to 2 months, we can extend the 
enrollment period by 1 additional month while still having individuals be able to complete the necessary 
number of classes.  
5.
Brochure added 
Rational: Difficulty with participant accrual. 
We have received multiple requests from potential participants as well as physicians interested in sending 
their patients to us for a brochure that they can have to help them learn more about the study and contact 
us more easily. We believe that the addition of this brochure may significantly help increase our accrual 
rate, especially by decreasing effort on the part of other providers. 
Detailed description of changes
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The following changes have been made in the document “HRP-591 Protocol for Human Subjects 
Research – Study 00008646 Creative Writing Study – IRB – Amendment 1 protocol v2 tracked edits 
6.12” – you can see these same changes on the Tracked Changes version of the protocol as well:
4) Section 7.3 Key Inclusion Criteria, second bullet point – removed description of criteria for new 
diagnosis and replaced with “Any patient with a cancer diagnosis”
5) Section 7.7 Subject Recruitment, first paragraph, sentence 2 
 - removed “newly diagnosed” 
6) Section 9.2 Design, first paragraph, sentence 3 
- changed three to “four-month period”
- added “2-3” month workshops
7) Section 9.3 Study Duration, second paragraph starting with “Length of participants..”
- Changed from 3 to 2-6 months for length of participation
8) Section 9.5 Study Schema, Figure 1: 
- edited study schema to reflect enrollment for 4 months and that intervention and control  groups will 
participate for at least two month 
- Edited inclusion criteria to include any patient with a cancer diagnosis 
9) Section 10.1 Methods 
First paragraph:
- added “Each patient will be asked to attend at least two classes per month for a total of two months.”
- Changed 3 month study period to 2 month study period
- Changed enrollment from 1st 3 months to 1st 4 months 
Second paragraph, last sentence:
- Added “two to three” for length of study period
Third paragraph:
- Sentence 2 – changed three to “two” month participation and replaced 6 with “4” sessions. 
10) Section 11.1 Statistical Plan, paragraph 1
- Added “time from cancer diagnosis (first 3 months, 3-6 months, more than 6 months)” as additional 
factor that will be used in the subset analysis 
The following changes have been made in the document “Consent for Creative Writing Study 00008646– 
Amendment 1 V2 Clean 6.12” – you can see these same changes on the Tracked Changes version of the 
consent as well:
1) Section 1. Why is this research study being done?
- Changed last part of first sentence to “because you have a cancer diagnosis”
2) Section 2. What will happen in this research study?
- Third paragraph: Changed number of workshops to 4 and changed duration of participation to two total 
months, with at least two class attended per month
- Changed study figure to reflect above stated change
3) Section 6. How long will I take part in this research study?
- Changed number of classes to 4 and duration of study to 2 months
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HRP-591 - Protocol for Human Subject Research 
Application for Review of Human Research: IRB Protocol Summary
Protocol Title: Effect of Group Led Creative Writing on Mood in Cancer Patients
Principal Investigator:
Name: Monika Joshi, MD, MRCP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: mjoshi@pennstatehealth.psu.edu
Co-Investigators: 
Name: Muhammad Hussain, MD (Co-PI)
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-0003 Ext:285177
E-mail Address: mhussain2@pennstatehealth.psu.edu
Name: Darya Nesterova, BS (Co-PI)
Department: College of Medicine
Telephone: 571-723-5722
Email: dnesterova@pennstatehealth.psu.edu
Name: Monali Vasekar, MD
Department: Medicine
Division: Hematology - Oncology
Telephone: 717-531-8678
E-mail Address: mvasekar@pennstatehealth.psu.edu
 
Name: Jacqueline Heath, BS 
Department: College of Medicine
Telephone: 201-647-7084
Email: jheath2@pennstatehealth.psu.edu
Name: Joseph Drabick, MD FACP
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: jdrabick@pennstatehealth.psu.edu
Name: Cristina Truica, MD
Department: Medicine
Division: Hematology-Oncology
Telephone: 717-531-8678
E-mail Address: ctruica@pennstatehealth.psu.edu
 
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Name: Michael Hayes, Ph.D.
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-0003 Ext: 289370
E-mail Address: mhayes3@pennstatehealth.psu.edu
 
Biostatistician
Name: Junjia Zhu Ph.D.
Department: Public Health Services
Division: Biostatics
Telephone: 717-531-1509
E-mail Address: jzhu@phs.psu.edu
Collaborators:
Name: Aditya Joshi, MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531-2947
E-mail Address: auj3@psu.edu
Name: Erika F.H Saunders MD
Department: Psychiatry
Division: Adult Psychiatry
Telephone: 717-531- 8516
E-mail Address:efs11@psu.edu
Version Date:
March 8th, 2018
Clinicaltrials.gov Registration #: N/A
If you need help…
University Park and other campuses:
Office for Research Protections Human Research Protection 
Program
The 330 Building, Suite 
205UniversityPark, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Hershey Medical Center:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building Room 1140)
Phone:717-531-5687
Fax number: 717-531-3937
Email: irb-hspo@psu.edu
Instructions for using this protocol template:
9.
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) in the “Basic 
Information” section. Links to Penn State’s protocol templates are available in the same location where 
they are uploaded, and their use is required.
10. This template is provided to help investigators prepare a protocol that includes the necessary 
information needed by the IRB determine whether a study meets all criteria for approval. 
11. There may be sections in this template that do not apply. If a section or question does not apply to the 
research study in question, provide the response “Not Applicable.”
12. DO NOT TYPE IN THE GRAY BOXES.  All guidance language appears in gray boxes and these boxes 
MUST be deleted from the final version of the protocol prior to upload to CATS IRB.
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Table of Contents
1.0
PROTOCOL TITLE
2.0
STUDY SPONSORSHIP
3.0
PROTOCOL ABSTRACT
4.0
OBJECTIVES
5.0
BACKGRUND
10.0
...............................................................................................................RATIONALE AND HYPOTHESIS
11.0
.......................................................................................CHARACTERISTICS OF STUDY POPULATION
7.1 TARGET POPULATION
7.2 ACCURAL
7.3 KEY INCLUSION CRITERIA
7.4 KEY EXCLUSION CRITERIA
7.5 VULNERABLE POPULATION
7.6 POPULATIONS VULNERABLE TO UNDUE INFLUENCE OR COERCION
7.7 SUBJECT RECRUITMENT
8.0
CONSENT PROCESS AND DOCUMENTATION
9.0
STUDY DESIGN
9.1 PHASE
9.2 DESIGN
9.3 DURATION
9.4 ENDPOINTS
9.5 STUDY SCHEMA
12.0
STUDY PROCEDURES
10.1 METHODS
10.2 CLINICAL COVARIATES
10.3 CREATIVE WORKSHOP
10.4 EMOTIONAL THERMOMETER SCALE
10.5 CONTROL GROUP ACTIVITES
11.0
STATISTICAL PLAN
12.0
CONFIDENTIALITY
13.0
PRIVACY
14.0
DATA AND SAFETY MONITORING
15.0
RISK/BENEFIT ASSESMENT
16.0
SUBJECT COMPENSATION
17.0
NUMBER OF SUBJECTS
18.0
RESOURCES AVAILABLE
19.0
ADVERSE EVENT REPORTING
20.0
STUDY MONITORING, AUDITING AND INSPECTING
21.0
REFERENCES
22.0
TABLES
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1.0
PROTOCOL TITLE
1.1
Effect of Group Led Creative Writing on Mood in Cancer patients.
1.2
Brief Title: Effect of Creative Writing on Mood in Cancer Patients.
2.0
STUDY SPONSORSHIP
2.1
Funding Sponsor:
Penn State Hershey Cancer Institute
Fifty Shades of Pink (Breast Cancer Endowment Fund)
2.2
Primary Sponsor:
Penn State Hershey Cancer Institute
3.0
PROTOCOL ABSTRACT
The primary purpose of this study is to determine whether creative writing in newly diagnosed cancer 
patients and those with recent progression in their disease will have a positive impact on their mental 
health. Using a randomized controlled trial approach, emotion thermometers will be employed to 
evaluate participants’ responses on a number of domains, such as anxiety, depression, despair, and 
anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. 
Open-ended survey questions will be used to capture how a creative writing intervention impacts 
participants’ experience of their illness. Melissa Greene’s Write from the Heart program focuses more 
on creative writing rather than cancer focused topics. Patients in the intervention arm will complete –
one and a half hour group sessions every two weeks over the span of 3 months. Participants in the 
active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg) about 
creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a period of 2-3 months.
4.0
OBJECTIVES
4.1
Primary Objectives:  

Mental wellness before and after intervention in the intervention and control groups. A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
reflecting participants’ mental health pre- and post-intervention. Survey questions 
focused on symptoms of depression and anxiety will be used to monitor for changes in 
mental wellness pre- and post-intervention. 
4.2
Secondary Objectives: 

Comparison of mood scores, depression and anxiety symptoms versus frequency of 
attendance in the intervention arm. 

Comparison of somatic symptom burden between intervention and control group.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms after workshop between genders. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between patients living alone versus with family.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms between various cancer types.

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who have previously attended a creative writing class versus 
those who have not. 

Difference in mood scores, depression symptoms, anxiety symptoms, and somatic 
symptoms in individuals who completed control group activity and then enrolled in the 
workshops and attended at least one session. 

Comparison of the frequency of emergency room visits and hospitalizations between 
intervention and control group during the study period.
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
Comparison of cancer status (stable, progressing, in remission) between intervention 
and control group.
5.0
BACKGROUND
5.1 Scientific Background and Gaps 
Cancer is a life-threatening, feared diagnosis and is a source of great distress in patients. Hence in 
addition to treating cancer, one must address the emotional well-being of patients. 
Creative activity has a significant history in providing a wide range of psychological and 
physiological benefits for cancer survivors (King et al., 2012). When individuals experience a stressful 
life event or crisis, the higher verbal functions in the cerebral cortex become less accessible (Hass-
Cohen, 2008.) Therefore, patients who face such stressful life events of cancer are often left without 
words to describe their experiences of feelings (Green & Young, 2015). Findings from Green and 
Young (2015) suggest that creative visual expression, engaging both in an individual and the 
therapeutic setting, offered an opportunity for young adult survivors to express their emotions from 
deep within their bodies. It created self-understanding and a sense of healing. 
In another study by Bolton (2007) patients indicated that they found the therapeutic writing process 
beneficial. For example, one participant narrated, “It made it less traumatic than it might have been 
otherwise.” Creative writing has been recognized to explore and express personal thoughts, feelings, 
and experiences. Lau Tsu (1973) showed that writing facilitated patients’ ability to discover what they 
thought felt and remembered. Therapeutic creative writing enhanced their awareness of and ability to 
express issues to which attention and focus are required. (Esterhing BA et al., 1999)
There is a substantial area of agreement that language, narrative storytelling, forms an essential 
element in the construction of a coherent identity, sense of self and connectedness to others, and 
therefore, it is a powerful tool in creative therapy (Smyth, 1998; Wright & Chung, 2001). Roe and 
Davidson (2005) argue that processes of re-authoring one’s life story are actually integral components 
of the recovery process itself. A study by Stanton (2002) of breast cancer patients prompted to write 
about their cancer experience showed a significant decrease in self-reported somatic symptoms and 
medical appointment visits for cancer-related morbidities three months after participation in the study. A 
follow-up study by Stanton (2013) encouraged breast cancer patients to create personal websites to 
chronicle their experience and to communicate with their social network. This study showed significant 
improvement in positive mood and depressive symptoms after 6 months, particularly in patients 
undergoing medical therapy at that time.  These studies further support that the act of narrative story 
telling can improve patient wellbeing. 
Furthermore, King et al. (2012) suggest that writing can contribute to repair of symbolic functioning 
and contribute to the development of personal identity. The researchers concluded that, of all the 
creative arts, writing is least dependent on equipment and/or special environments. Writing workshops 
are probably better provided by professional writers than by mental health professionals. When health 
professionals provide activities such as a writing workshop, there is a risk that identification with the 
illness is reinforced. On the other hand, when a professional writer provides a similar activity, it is the 
participant’s identity as a writer that is reinforced, rather than their identity as a person with an illness. 
(King et al., 2012)
Moreover, there is emerging consensus in the UK and USA that there might be advantages if 
writing therapy is received from facilitators who themselves are trained writers and can work in 
collaboration with health care professionals. (Hunt & Sampson, 1998; Mc Loughlin, 2004).
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  5.2   Previous Data 
We conducted a pilot study to determine feasibility whether cancer patients can be enrolled, 
randomized and retained for four weeks for creative writing classes (Feasibility was defined as 50% of 
our enrolled patients on intervention arm (IA) could attend at least 2 classes). We anticipated enrolling 
45 patients over the period of 2 months with randomization into 2 arms: IA and standard of care (SOC). 
“Write from the Heart” a series of creative writing workshops (CWW) were conducted on IA. Subjects in 
IA had four, 2-hour weekly CWW whereas SOC arm did not receive any session. We used validated 
Emotional Thermometer Scales (ETS), ranging 0 (best)-10 (worst), to predict changes in a number of 
parameters reflecting patient’s mental health pre and post intervention. ETS has five dimensions 
(distress, anxiety, depression, anger and need help), which are all continuous variables.  Due to time 
constraints we were not able to accrue the desired number of patients. A total of 16 patients were 
accrued in 1 month period -11 in IA and 5 in SOC. 7 out of 11 (63%) patients enrolled in IA attended at 
least 75% of classes. Comparisons were made using two-sample T-tests. Although sample size was 
small, IA did show a decreasing pattern on Total Emotion Score (TES), particularly in depression and 
anxiety scores (See table 1 and figure 1, 2). For each visit, post-class scores were lower than pre-class 
scores. We observed that it is feasible for cancer patients to attend focused workshops geared towards 
mental health wellbeing. IA showed a trend towards mood improvement, although was not shown to be 
statistically significant which may be attributed to the small sample size. Having shown the feasibility of 
such a study, we hope to increase the sample size and include more specific methods for quantifying 
mood improvement in the patient groups. In addition, after reviewing the suggestions (post completion 
of the study) from the patients who attended these sessions on the study, we concluded that 1.5hours 
of class twice a month is feasible and helpful for patients. 
Table 1: Mean and Median TES at baseline and after intervention in SOC versus IA.
Fig 1: Total Emotions Scores before and after each 
visit.
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Fig 2, A-D: Emotions Scores before and after each visit; A-D: A-Distress, B-Depression, C-Anxiety, D- Anger
6.0
RATIONALE AND HYPOTHESIS
6.1
RATIONALE:
Cancer generates an increased sense of distress than non-malignant diseases with poor 
prognoses (Mishel et al., 1984). Persistent mental distress for prolonged periods leads to anxiety and 
depression. The rate of depression in cancer patients is thought to be up to three times higher than in 
the general population (Linden et al., 2012). Depression leads to a poorer quality of life (QOL) and 
affects patient outcomes, with depression resulting in higher rates of mortality in cancer (Colleoni et al., 
2000, Pinquart et al., 2010). A meta-analysis revealed that minor or major depression increases 
mortality rates by up to 39%, and that patients displaying even few depressive symptoms may be at a 
25% increased risk of mortality (Satin et al., 2009). The impact of mood and mental wellbeing on cancer 
progression is considered important by doctors and patients, with >70% of oncologists and 85% of 
patients believing that mood affects the progression of cancer (Lemon et al., 2004). Our previous data 
as mentioned before shows that creative writing is feasible and needs to be further studied to 
understand the effect of group therapy with focused workshop in newly diagnosed or patients with 
recent recurrence. In addition, we observed that the emotional thermometer scale was not enough to 
capture the mood of the patients. For example, some patients felt significantly better after attending 
these sessions and were able to cope with their symptoms but the emotional scale did not reflect that 
benefit. 
6.2
HYPOTHESIS:
This study aims to look at the impact of participating in creative writing workshop group Write 
from the Heart, on cancer patients’ emotional well-being. Keeping previous studies in mind, a 
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professional writer will conduct the workshops, which will enhance the participant’s ability to express 
and enhance their awareness. We anticipate that participation in the workshop will result in a positive 
effect on the parameters being studied, enabling patients to cope with their illness/cancer better.  We 
hypothesize that group sessions of creative writing workshop could be better than individual sessions. 
7.0
CHARACTERISTICS OF THE STUDY POPULATION
7.1
Target Population
Adults with a new diagnosis of cancer, at any stage OR progression of  
cancer- within three months of enrollment.   
7.2
Accrual
We aim to accrue 60 eligible patients over a time span of 2 months at the Milton S. Hershey 
Medical Center.
7.3
Key Inclusion Criteria

Adult >20 years of age 

Any patient with a cancer diagnosis. 

Ability to understand English language and ability to write without any functional difficulty

ECOG performance status 0-3
7.4
Key Exclusion Criteria 

Inability to give informed consent

Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis) 

Severe cognitive impairment

Pregnant females

Inability to write or understand English
7.5
Vulnerable Populations 
None
7.6
Populations vulnerable to undue influence or coercion
If a patient who works for or has some affiliation to Pennsylvania State University happens to be 
in the potential participant pool, we will verbally stress to him/her that their participation is 
voluntary and will not influence her care or any outcomes related to Penn State. 
7.7
Subject Recruitment 
We will recruit participants from our outpatient cancer clinics at HMC (Hershey Medical Center). 
We will create a pamphlet describing our study briefly and study staff contacts, then distribute in 
all cancer clinics. This will be given to every cancer patient at any stage, with recurrence, or with 
progression at HMC. We will also send emails to physicians and nurses at outpatient cancer 
clinics at HMC for study description and our contact details. If patients are interested, we (study 
staff) will conduct initial eligibility screening and obtain informed consent from patients to initiate 
study follows up. 
10.0
CONSENT PROCESS AND DOCUMENTATION
10.1
Consent Process
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10.1.1 Obtaining Informed Consent
Physician-Investigators of the study will identify patients from their clinic and 
patients will be approached to participate in the study. Study staff will then discuss the study in 
detail to make the patient aware of the workshops, intervention, and time commitment involved 
with the study. If the patient is interested, study staff will answer any remaining questions and 
obtain written informed consent at the patient’s clinic visit with their primary oncologist.
8.1.2
Coercion or Undue Influence during Consent
If a patient affiliated with Pennsylvania State University happens to be in the potential 
participant pool, we will inform them that their participation is voluntary and will not influence her 
care or any outcomes related to Penn State. 
8.1.3  Waiver of Authorization
Not applicable
8.6
Consent Documentation
8.6.1
Written Documentation of Consent
Study staff members will assist with data and consent collection. If the patients are unable or not 
competent to give consent, they will not be enrolled in the study.
8.7
Consent – Other Considerations 
8.7.1.1 Non-English Speaking Subjects
Not included.
8.7.1.2 Cognitively Impaired Adults
Not included.
8.7.1.3 Subjects who are not yet adults (i.e., infants, children, teenagers) 
Inclusion criteria: greater than 20 years of age
9.0
STUDY DESIGN
  
9.1
Phase
Phase II
9.2
Design
The focus of this study is to determine the difference in mental health parameters following the 
participation of cancer patients in a creative writing workshop. Participants will be randomized 
within strata formed by cancer type in order to assure that these potentially important 
confounding variables are balanced across groups. Patients will be enrolled on a rolling basis 
over a three-month period, allowing patients in intervention arm to participate in 2-3 months 
workshops (workshops would be held once every 2 weeks). Patients in control arm will be 
provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be 
asked to do activities for 1.5 hours every 2 weeks. After three months, control group participants 
can join creative writing workshops at their discretion for the remaining period for writing 
workshops. Both group members will receive follow up surveys twice a month for two months at 
the completion of the participant’s three-month study period.  
9.3
Study Duration 
Estimated time to enroll all subjects = 3-5 months (Patients will start being enrolled after IRB 
approval and we will continue the enrollment up to 3 months from the time the 1st class starts for 
the intervention group)
Length of a participant's participation = 2 - 6 months; Follow up after participant’s completion of 
classes = 2 months 
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9.4
Endpoints:
9.4.1
Primary endpoints: 

Mood scores before (at baseline) and after intervention (after completion of entire 
sessions - this may vary as some patients may not be able to complete six sessions). A 
validated Emotional Thermometer Scales will be used to predict changes in parameters 
pre and post-intervention.

Severity of depression and anxiety symptoms before and after intervention between two 
groups. Validated Depression and Anxiety questionnaires will be used to predict 
changes, the PHQ-9 and GAD-7 respectively. 
9.4.2
Secondary endpoints: 

Mood and symptoms before and after at least 2 sessions of intervention. 

Self-reported somatic symptoms pre and post intervention in two groups. We will use the 
Somatic Symptom Scale – 8 (SSM-8) to quantify somatic symptom burden. 

Difference in scores and symptoms between various genders.

Difference in scores and symptoms between patients living alone versus with family.

Difference in scores and symptoms in different cancer types.  

Difference in scores and symptoms versus number of classes attended. 

Differences between individual mood scores for patients in the control group who later 
switch to intervention group and attend at least one session

Mood and symptom scores up to 2 months after completion of the study. 
9.4.3    Exploratory endpoints

Difference in number of emergency room visits and hospitalizations during study period 
between control and intervention group. 

Comparison of status of cancer (stable, progressing, in remission) between intervention 
and control group.
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9.5
Study Schema
                        Figure 1:
Enrollment in clinic 
setting
Intervention n= 40
1.5 hours  twice a month 
(every other week or per 
patient's convenience) 
with Melissa Greene for 2 
months 
Rolling enrollment  during 
first 4 months  of the 6 
month workshop series with 
the intention that patients 
enrolled can attend 2 
consecutive months
Control n= 20
Receive Creative Writing 
workbook to do for 1.5 
hours every other week for 
2-3 consecutive months
Patients who complete 
control criteria during first 
2-3 months or more are 
given the opportunity to 
join intervention arm for 
the remainder of the study 
duration- their individual 
data will be collected and 
compared to their previous
All patients would be 
followed for 2 months post 
completion of their 
assigned initial 2-3 month 
clasess
Patient population
N=60
Inclusion criteria: 
-Any patient with a cancer 
diagnosis.
-Ability to understand English 
language and ability to write 
without any functional difficulty
-ECOG performance status 0-3
Primary end points:
1. Mood scores
2. Depression and Anxiety scores 
10.0
STUDY PROCEDURES
10.1
Methods:   After enrollment as above, co-investigators of this study or the assigned 
coordinator will be doing the consent. Patient will be randomized to intervention and control 
arms in a 2:1 ratio. The intervention arm will receive a dedicated workshop for one and a half 
hours every 2 weeks.  We aim to start a 6 month long program with weekly creative writings 
workshops, and patient enrollment in the study will continue through the 1st 4 months of the 6 
month period so that the last enrolled patient could complete the 2 month study period of every 
two week workshops. Each patient will be asked to attend at least two classes per month for a 
total of two months. These workshops will be held at Hershey Medical Center (HMC). At the 
initiation of the study along with consent we will collect baseline scores in both groups for each 
parameter as below. Somatic Symptom Burden (SSM-8 - Figure 2 - reference section), 
depression symptoms using PHQ-9 (Figure 3 – reference section), and anxiety symptoms using 
GAD-7 (Figure 4 –reference section) will be collected monthly and following intervention 
completion. 
We will collect mood scores pre and post each session. We will use Emotional Thermometer 
Scale (EMS) from Dr. Alex J. Mitchell (Feb. 2010), diagram for scales is shown in figure 1. 
Please see supplementary index for a letter of permission to use from Dr. Mitchell. We will give 
the Thermometer scales and collect scores pre and post each session and also collect scores 
pre and post completion of entire course. Control group will do EMS on monthly basis along with 
other parameters. At the end of the study we will review all participants’ medical charts to count 
view the number of emergency room visits and hospitalizations each participant experienced 
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during the study period. These will be further broken down in categories based on cancer 
related vs non-cancer related visits.  We will also review their most current cancer disease 
status after completion of the workshops and categorize whether their status is considered to be 
stable, progressing, or in remission. Both groups will also receive follow up mood and symptom 
surveys twice a month for up to 2 months after completion of the participant’s two to three 
month study period. 
The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative 
writing and asked to read and do writing activities for one and a half hours once every two 
weeks. At the completion of the two-month participation or completion of 4 sessions control 
patients will be given the opportunity to enroll in the creative writing workshops for the 
remainder of the study period of 6 months. We will collect scores from control arm through the 
same Emotion Thermometers Scale on a monthly basis. Pre-intervention scores will be 
obtained at the time of consent or one week prior to the planned start of session 1 for workshop 
(either in the clinic if possible or mail the score sheet to patients with an enclosed stamped 
envelope for return of the scales). Depending on participant preference, we can send them 
emails of the REDCAP surveys containing the same information at set intervals. A sample of the 
REDCAP surveys is included in supplementary materials. We will also send participants in the 
control arm a stamped return envelope on a monthly basis if not able to get score sheets in a 
clinic or over REDCAP, depending on patient convenience and preference. We will call the 
participants once every 3-4 weeks to check in on their progress. Please see a calendar at the 
end for details. 
To assess for possible confounding results of patients participating in the concurrent exercise 
study, we will ask participants if they are also enrolled in the exercise study at enrollment and 
perform a subset analysis for patients who are in the exercise study. They will be randomized 
into either control or intervention group in the same manner as the other patients in the study. 
We will additionally include a section of the survey to ask about regular exercise (more than 30 
minutes, three times a week) and do a subset analysis of these patients as well.   
 
We will be collaborating with the Department of psychiatry at HMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who requests psychiatry follow up will be 
referred to Dr. Michael Hayes.  If participants report the presence of suicidal ideation per 
question nine on the PHQ-9 [i.e., Thoughts that you would be better off dead or of hurting 
yourself in some way], they will be referred on an urgent basis to Dr. Michael Hayes or Dr. 
Aditya Joshi. In the event Dr. Hayes and/or Dr. Joshi are unavailable for follow-up,  If any active 
suicidal thoughts are reported, participants will be referred directly to Emergency Department at 
Hershey Medical Center. 
10.2
Clinical Covariates:  Detailed clinical covariates will be obtained from questionnaires and 
medical record review including demographics (age, gender, race), cancer type and stage, 
psychiatric history, chemotherapy regimen and medication use.  
10.3
Creative Workshop: Write from Heart: This workshop for cancer patients usually lasts one 
and a half hours and is broken into several parts. Usually beginning with inspirational quotes or 
passages from writings of respected authors, to shift mood and illuminated deeper thought and 
reflection. The next phase of the class consists of sharing a beautiful or whimsical object 
handed person to person or placed in the middle of the table to stimulate both curiosity and the 
senses. When participants are able to relax fully, in tranquil and focused surroundings the 
imagination easily transforms a bright polished stone or a glass heart with inner fractures into a 
metaphorical image. The technique of journaling is also encouraged in class, as a way to 
promote inner awareness to strengthen writing skills and to guide students to reach for their own 
comfort and consolation, when not in class. Within our setting, it is normal, though not 
mandatory that writing may lean toward the cancer experience. At the end of each series, 
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students would have learned how to trust their artistic instincts, connect more courageously with 
the world of their emotions and transform their fears and revelations about cancer into words on 
the page. 
10.4     Emotional Thermometers Scale: The Emotion Thermometers tool is a simple rapid modular 
screening tool for detection and monitoring of emotional disorders in clinical practice. It was 
created by Dr. Alex J Mitchell and has a simple visual-analogue design. It is easy for most 
patients (including older people) to understand, quick to administer and simple to score. We 
have already got permission from Dr. Alex J Mitchell for royalty free usage of this scale for 2 
years starting from Aug, 2016 till Aug 2018. We will be getting permission from him to extend 
the usage for an additional 1-2 years. 
10.5    Survey of Depression and Anxiety symptoms: For anxiety, we will use Generalized Anxiety  
Disorder 7-item (GAD-7) validated scale by Robert Spitzer et al. For depression we will use 
Patient Health Questionnaire 9–item (PHQ-9) validated scale by Robert Spitzer et al.  Both of 
these scales do not require any permission for reproduction, display, distribution or usage. 
10.6
Control group activities: Participants randomized into the control group were asked to 
maintain their usual follow up while also reading a book on creative writing for one and a half 
hours every other week for three months, logging their activity for verification of task completion.  
Their mode scores will be measured as mentioned above.
13.0
Statistical Plan
13.1
Statistical Analysis Plan
Participants’ basic demographic and baseline clinical measurements will be summarized using 
descriptive statistics. Those summarizations will be based on all patients as well as on patients 
within each group. This study has several main groups of outcome variables, which reflect several 
different domains of patient’s mental health. The first group is the emotion thermometer (which has 
five sub-scales), the second is the somatic symptom scale (SSS-8), the third is the Patient Health 
Questionnaire (PHQ-9), and the fourth is the Generalized Anxiety Disorder questionnaire (GAD-7), 
which measures participants’ anxiety. All the above outcome variable groups are based on 
questionnaires using Likert-scale questions to take the measurements, and each group may 
involve multiple sub-dimensions. Both the intervention group and the control group have repeated 
measures of the outcomes as shown in Figure 1. Graphical methods (such as the line plot of 
mean/SD values vs. time) will first be used to illustrate the mean and standard deviation values of 
the mode, depression, and anxiety scores through the time for both groups. These methods will 
help us detect the patterns of how the scores change over time (within-group change) and how the 
scores differ between groups. We will further use the linear mixed-effect model for repeated 
measures to analyze the within-group and between-group differences. Every sub-dimension will be 
analyzed individually, but we will also analyze the composite score for the dimensions. For the 
patients in the control group this study involves two stages (week 1-12 and week 13-20), and at the 
end of the 12th week, they can join the intervention group. This setting will allow us to study the 
effect of the intervention on the control group alone. For this part of analyses, linear mixed-effect 
models will be set up with the stage serves as an indicator variable in the model. The comparison 
of outcome variables between certain time points will also be done using paired tests. We will 
further investigate the possible factors that might affect the change of outcome variables over time. 
The factors are gender, race, marital status, time from cancer diagnosis (first 3 months, 3-6 
months, more than 6 months) and cancer stages. This part of analyses will mainly be focused on 
the intervention group and the above factors will be examined in the linear mixed-effect models. All 
analyses will be performed using statistical software SAS version 9.4 or higher (SAS Institute, 
Cary, NC, USA) and the statistical significance level to be used is 0.05.
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13.2
Sample size considerations:
We plan to enroll a total of 60 participants in the study – with 40 participants in the intervention 
group and 20 participants in the control group (2:1 ratio). This sample size is mainly determined by 
the capacity of the workshop. With this sample size we are able to detect a standard effect size 
(the mean difference measured in common standard deviation) of 0.45 with at least 80% statistical 
power (using two-sample repeated measure ANOVA model, assuming four time-points, and the 
within-patient auto-correlation being 0.2) . 
12.0
CONFIDENTIALITY
How will confidentiality of data be maintained?  Check all that apply.
 Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study.
 Use of a code number to label all research data
 Use of a study ID code linking list that will be maintained separate from the research data files 
on the HMC server (identifiers)
 Computer-based files will only be made available to personnel involved in the study through 
the use of access privileges and passwords.
 Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and confidentiality of identifiable information.
 Whenever feasible, identifiers will be removed from study-related information.
 A Certificate of Confidentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject’s financial standing, employability, 
or liability.
 A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
confidentiality.  (This is not an option for FDA-regulated research.) 
 Precautions are in place to ensure the data is secure by using passwords and encryption, 
because the research involves web-based surveys.  
 Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
 Other (specify): All data entered and stored in RedCap database (the proxy PI has an active 
RedCap account) and will be used to transfer data in a deidentified format only.
12.11 Identifiers associated with data and/or specimens
Identifiers like dates and medical record numbers will be used.
12.12 Use of Codes, Master List
Use of a code linking list will be maintained separate from the research data files on the 
HMC server.  All data entered and stored in HIPAA compliant RedCap database (the 
proxy PI has an active RedCap account) and will be used to transfer data in a deidentified 
format only.
12.13 Storage of Data 
All electronic files will be encrypted and/or password protected-EXCEL database, stored 
on a hard drive in locked HMC offices. Paper files will be stored in locked HMC offices/labs of 
the research team. These will be deleted/ shredded/destroyed at the end of study approval 
period. Information will be kept confidential and private and managed according to HIPAA 
guidelines.
12.14 Access to Data 
Research team consisting of PI, Co-investigators, team participants, biostatisticians only 
will have access to the data
12.15 Transferring Data
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Not applicable.
13.0
PRIVACY
Protected health information that will be obtained includes patient name, medical record number, and 
date of birth.  This information will be kept in a password-protected database in Excel sheet, behind the 
Pennsylvania State University firewall as well as the RedCAp database (Co-PI has an active RedCap account).  
Identifying information will be stored in a separate portion of the database, linked to the analytical database 
through an alphanumeric code.  Published data will only report aggregate, de-identified results.
14.0
DATA AND SAFETY MONITORING
All clinical information will be kept confidential, in a password-protected database or locked, secure 
location and managed according to HIPAA guidelines.  
14.17 Periodic evaluation of data 
Data evaluated at our site only. 
14.18 Data that are reviewed 
Data reviewed at our site only.
14.19 Method of collection of safety information
Data collected safely in a HIPAA compliant, encrypted database- Excel and REDCAP database. 
Access limited to PI and proxy PI and co-investigators only.
14.20 Frequency of data collection
Biweekly
14.21 Individual’s reviewing the data
PI, co-investigators, and statistician from our institution only
14.22 Frequency of review of cumulative data
Every month
14.23 Statistical tests
As mentioned in detail in statistics section
14.24 Suspension of research
Unable to do workshops.
14.9
Multi-center Research
Not applicable
15.0
RISK/BENEFIT ASSESSMENT
15.1
Potential Study Risks
Minimal. It is an intervention to determine changes in mood scales before and after creative 
writing workshop, and we anticipate minimal risk (breach of confidentiality – measures taken as above) for 
patients regarding their underlying cancer or treatment.
15.2
Potential Study Benefits
Participants randomized to the intervention with creative writing workshops may experience an 
improvement in their mood. We suspect that patients may have better adherence to their cancer therapy, but 
we do not expect any effect on cancer overall. 
  
15.3
Alternatives to Participation
Not participating.
16.0
SUBJECT COMPENSATION
No compensation will be provided. Coffee and light snacks will be served with every workshop.
17.0
NUMBER OF SUBJECTS: 60 
17.1
Intervention Arm: 
40
17.4
Control Arm:
20
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24.0
RESOURCES AVAILABLE
18.1
Facilities and locations
Only the patients seen at Penn State Hershey Cancer Institute will be included. PI has been 
involved in numerous previous studies at this location.
18.8
PI Time devoted to conducting the research
The PI will be devoted to conducting the research. The Co-PIs will have dedicated research 
time during their training to conduct the research. The study team will meet at biweekly intervals 
to review progress and provide feedback.
18.9
Availability of medical or psychological resources:
We will be collaborating with the Department of psychiatry at PSHMC - Dr. Aditya Joshi, Dr. 
Michael Hayes, and Dr. Erika Saunders. Any subject who request psychiatry follow up will be 
referred to Dr. Joshi.
18.10 Process for informing Study Team
The study team will meet at biweekly intervals to review the progress of the study and to provide 
feedback.
25.0
ADVERSE EVENT REPORTING: 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
The only possible adverse event or unanticipated problem is the loss of confidentiality, and as far as 
loss of confidentiality is concerned, in accordance with applicable policies of The Pennsylvania State 
University Institutional Review Board (IRB), the investigator will report, to the IRB, any observed or 
reported harm (adverse event) experienced by a subject or other individual, which in the opinion of the 
investigator is determined to be (1) unexpected; and (2) probably related to the research procedures. 
Harms (adverse events) will be submitted to the IRB in accordance with the IRB policies and 
procedures.
26.0
STUDY MONITORING, AUDITING AND INSPECTING
The investigator will permit study-related monitoring, audits and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g. workshop room etc.).
21.0
REFERENCES:

Bolton G. (2008).”Writing is a way of saying things I can’t say”__ therapeutic creative writing: a 
qualitative study of its value to people with cancer cared for in cancer and palliative healthcare. Journal 
of Med Ethics; Medical Humanities, 34, 40-46.

Colleoni M, Mandala M, Peruzzotti G, et al. Depression and degree of acceptance of adjuvant cytotoxic 
drugs. Lancet. 2000;356:1326–1327. 

Esterling BA., L’Abate L., Murray EJ, et al. (1999). Empirical foundations for writing in prevention and 
psychotherapy: mental and physical health outcomes. Clinical Psychol Rev, 19, 79-96.

Gierk B, Kohlmann S, Kroenke K, et al. The Somatic Symptom Scale–8 (SSS-8). JAMA Intern Med. 
2014;174(3):399

Green A.R & Young R.A. (2015) The lived experience of visual creative expression for young adult 
cancer survivors. European Journal of Cancer Care 24, 695-706.  

Hass-Cohen N. (2008) CREATE: Art therapy relational neuroscience principals (ATR-N). In N. Hass-
Cohen & R.Carr (Eds), Art therapy and clinical neuroscience, London, UK: Jessica Kingsley Publishers.
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
Hunt, C. & Sampson, F.E. (Eds) (1998). The Self on the Page: Theory and Practice of Creative Writing 
in Personal Development. London: Jessica Kingsley. 

King, R., Neilson, P. & White, E. (2013). Creative writing in recovery from severe mental illness. 
International Journal of Mental Health Nursing, 22, 444-452.

Lao Tsu. Tao Te Ching (trans. Feng GF, English J). London: Wildwood House, 1973.

Lemon J, Edelman S, Kidman AD. Perceptions of the “Mind-Cancer” Relationship Among the Public, 
Cancer Patients, and Oncologists. J Psychosoc Oncol. 2004;21:43–58

Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: 
prevalence rates by cancer type, gender, and age. J Affect Disord. 2012;141:343–351

McLoughlin, D. (2004). Any-angles light: Diversity and inclusion through teaching poetry in health and 
social care. In: F. Sampson (Ed). Creative Writing in Health and Social Care. (pp.170-188). London: 
Jessica Kingsley.

Mishel MH, Hostetter T, King B, Graham V. Predictors of psychosocial adjustment in patients newly 
diagnosed with gynecological cancer. Cancer Nurs. 1984;7:291–299

Mitchell AJ, Baker-Glenn EA, Park B, Granger L, Symonds P. Can the Distress Thermometer be 
improved by additional mood domains? Part II. What is the optimal combination of Emotion 
Thermometers? Psychooncology. 2010 Feb;19(2):134-140 

Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by 
additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 
2010 Feb;19(2):125-33. 

Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 
2010;40:1797–1810. 

Roe, D. & Davidson, L. (2005). Self and narrative in schizophrenia: Time to author a new story. Medical 
Humanities, 31, 89-94

Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in 
cancer patients: a meta-analysis. Cancer. 2009;115:5349–536. 

Stanton AL, Danoff-Burg S, Sworowski LA, et al. Randomized, controlled trial of written emotional 
expression and benefit finding in breast cancer patients. J Clin Oncol. 2002;20(20):4160-4168

Stanton AL, Thompson EH, Crespi CM, Link JS, Waisman JR. Project connect online: randomized trial 
of an internet-based program to chronicle the cancer experience and facilitate communication. J Clin 
Oncol. 2013;31(27):3411-3417

Smyth, J.M. (1998). Written emotional expressions: Effect size, outcome types and moderating 
variables. Journal of Consulting and Clinical Psychology, 66(1), 174-184

Wright, J. & Chung, M.C. (2001). Mastery or mystery? Therapeutic writing: a review of the literature. 
British Journal of Guidance and Counselling, 29 (3), 277-291.
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22.0
TABLES and FIGURES for the STUDY
Table 1: DEMOGRAPHICS
Participant
1
2
3
4
5
6
7…
Serial Number
Alphaneumeric code
Medical Record Number
Gender
Age
Living Alone vs with 
family/caretaker
Primary Cancer Type
Cancer Stage
ECOG Performance Status
Enrolled in the Exercise 
Study
Regular exercise on or off 
the exercise study- >30mins 
three times a week
Current Treatment  
(Surgery, Radiation, Chemo) 
Disease status at 
completion of study (Stable, 
Progression, Remission)
Psychiatric history (previous 
diagnoses or 
hospitalizations)
Current Psychiatric 
Medications
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Figure 1: Emotion Thermometer Score (ETS)
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Figure 2: Somatic Symptom Scale
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Figure-3
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Figure - 4
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