Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial
Phase: NA
Conditions: Neoplasms
Sponsor: University of Arkansas

 
 
 
 
 
 
 
 
 
Self-affirmation intervention for people newly diagnosed with advanced cancer:  
A preliminary efficacy trial 
 
NCT 05235750 
 
March 27, 2024 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
1 
 
 
 
 
Study Title: Self-affirmation intervention for people newly diagnosed with advanced 
cancer: A preliminary efficacy trial 
 
 
Principal Investigator:  
Mei Bai 
College of Integrated Clinical Enterprise SUSL Surgical 
Specialties 
University of Arkansas for Medical Sciences 
4301 W. Markham St. 
Little Rock, AR 72205 
 
Email: MBai@uams.edu 
 
 
 
Study location: 
Winthrop P. Rockefeller Cancer Institute 
449 Jack Stephens Dr. 
Little Rock, AR 72205 
 
 
 
 
Arkansas Hospice 
 
14 Parkstone Circle 
 
North Little Rock, AR 72116 
 
 
 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
2 
 
Hypothesis and/or Specific Aims or Objectives 
The primary aim of this study is to explore the effects of self-affirmation via writing on 
patients newly diagnosed with advanced cancer, calculate effect sizes of the outcome 
variables, and estimate the appropriate sample size for the main study. 
 
The secondary aim is to test the validity of the functional assessment of chronic illness 
therapy- spiritual well-being 12 item scale (FACIT-Sp-12), in its current (Appendix A) 
and revised forms (Appendix B). 
 
It is hypothesized that: self-affirmation at the time following a diagnosis of an advanced 
cancer by affirming values or beliefs that are salient to self will help patients enhance 
self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and 
improve quality of life (QoL). 
 
Study Design and Procedures  
A single group time series study design will be employed (Figure 1). 
 
        
 
 
       Figure 1: Timeline for the four data collection points 
 
The intervention Participants will be asked to write as guided by the researcher 
starting from Time 2 (two weeks post-baseline) for 4 weeks. 
 
Specific criteria on the writing task: 
1) write with a focus on affirming one’s fundamental values and beliefs, 
2) write in connection with one’s cancer diagnosis, and 
3) write at least once for a minimum of 20 minutes per week for four weeks.  
 
To ensure that participants understand the nature and essence of the intervention, each 
patient will receive a page of writing instructions and a brief educational/informational 
session with the principal investigator (PI), both of which occur at two weeks post-baseline 
(Time 2 or T2); the writing instructions clarify the key expectations for the participants with 
respect to the writing intervention (in line with the criteria above) followed by examples to 
address what self-affirmation writing is and is not for this intervention. 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
3 
 
Both an online portal and notebooks for drafting and submitting the writings will be created 
for participants; patients may choose either approach to perform the writing task. At the 
end of the study period (or any other point), participants have the option to share their 
writings with the PI. However, given the high privacy nature of the content, sharing 
writings with the researchers is not required (which will be clarified with the participants) 
in order to encourage writing without reservation. 
 
Study Population 
The targeted participants are adult patients (age 18 or older) newly diagnosed with 
advanced cancer, and the total number of subjects to be enrolled will be a minimum of 50 
This sample size is chosen based on an estimated effect size of 0.4-0.5 to test differences 
between paired observations in one sample, with α 0.05 and power 0.80 (Cohen, 1988). 
 
The sample size estimate is tentative given the exploratory nature of this pilot study as 
the actual attrition rate as well as effect size may not be accurately predicted due to the 
high variability as found in the literature (Bai, 2021). 
 
Recruitment Strategy 
Patient recruitment for this pilot study will take place at two study sites: the Winthrop P. 
Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) 
and the Arkansas Hospice. 
 
The UAMS Winthrop P. Rockefeller Cancer Institute is Arkansas’ only academic cancer 
treatment and research facility. The PI will work with a study coordinator or a research 
assistant who helps identify and, if possible, consent eligible patients into the study. 
Specifically, the PI will receive patient referrals directly from the study coordinator or the 
research assistant for enrollment, meet with the potential participants, verify their eligibility 
before inviting them to join the study. The PI may also work directly with collaborating 
clinicians and/or accessing the electronic medical records to facilitate the enrollment 
progress. A waiver of the HIPAA authorization requirement will be requested for study 
enrollment purposes that permits the PI accessing the electronic medical records to 
identify potential study participants and/or verify their eligibility. 
 
 
The Arkansas Hospice is the state’s largest, non-profit hospice organization dedicated to 
enhancing quality of life for those facing serious illness and loss. The collaborating 
clinicians at the Arkansas Hospice will help identify eligible research participants and then 
refer these potential patients to the PI. The PI will go to meet with the potential participants 
and verify their eligibility before obtaining informed consent and the subsequent data 
collections. 
 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
4 
 
The PI will closely monitor the recruitment progress weekly and adjust/modify the 
recruitment method as necessary or seek/develop alternative recruitment strategies to 
ensure that the study recruitment proceeds timely. 
 
Inclusion Criteria 
• 1) within 8 weeks of being informed of diagnosis (primary or recurrent)  
• 2) cancer stage III or IV of a primary solid tumor, or a high-grade hematological 
malignancy, and 
• 3) age 18 years or older 
 
Exclusion Criteria 
• 1) medical condition precluding participation (e.g., too ill or fatigued, acute mental 
confusion as determined by the treating physician), or 
• 2) enrolled in other psychosocial experiments 
 
Measures 
Self-esteem 
The Rosenberg Self-Esteem Scale (RSES) is an extensively used scale measuring self-
esteem with demonstrated validity and excellent reliability (Rosenberg, 1965; Rosenberg, 
1979). Empirical studies have also demonstrated its sensitivity to change among the 
cancer population (Joseph et al., 2019; Mohd-Sidik et al., 2018). RSES is rated on a 4-
point scale from strongly agree to strongly disagree. Scores range from 3 to 0, with higher 
score indicating higher level of self-esteem. For this study self-esteem will be assessed 
by summing scores of the 10-item RSES (Appendix C).  
 
Spiritual Well-being 
The 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale 
(FACIT-Sp-12) (version 4) (Peterman et al., 2002) is one of the most widely used spiritual 
well-being scales. The scale is made up of 12 items scored on a 5-point scale evaluating 
levels of spiritual well-being during the previous week as indicated by the sense of peace 
and harmony, meaningfulness in life as well as strength and comfort derived from faith 
(Fitchett et al., 1996) (Appendix A).  
 
An overall score of spiritual well-being can be calculated by summating all the 12 items 
in the three factors of Peace, Meaning and Faith, ranging from 0 to 48, with higher scores 
indicating higher level of overall spiritual well-being. Prior studies supported high internal 
reliabilities of the scale (e.g., Bai & Dixon, 2014; Peterman et al., 2002), however with 
questionable construct validity on the Faith factor (Bai et al., 2016).  
 
In the revised version of this scale, the term “spiritual” will be replaced with “fundamental 
values and beliefs”, thereby overcoming the possible misinterpretation associated with 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
5 
 
the word “spiritual”. Pease refer to the enclosed measures for details of the revision 
(Appendix B). 
 
Anxiety and Depression 
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale that has 
been developed and found to be a reliable and valid instrument for detecting states of 
depression and anxiety in the setting of a hospital medical outpatient clinic as well as 
measuring severity of the emotional disorder (Zigmond & Snaith, 1983). A two-factor 
dimensional structure of the HADS was generally supported in the literature (Bjelland et 
al., 2002). The recommended thresholds for screening depression are 15 for the HADS 
total, 7 for the HADS depression subscale (Vodermaier & Millman, 2011) (Appendix D).  
 
Quality of Life  
The Functional Assessment of Cancer Therapy-General (FACT-G) (version 4) (Cella et 
al., 1993) was selected as measure of QoL in this study. FACT-G contains 27 items that 
are scored on a 5-point Likert scale (0-4), evaluating QoL of the previous week with high 
scores denoting better results. An overall QoL score can be calculated by summating all 
the 27 items in the 4 sub-scales of physical well-being (7 items), social/family well-being 
(7 items), emotional well-being (6 items), and functional well-being (7 items). Reliability, 
validity as well as equivalence by mode of administration (interview vs. self-
administration) has been supported for this scale (Cella et al., 1993; Webster et al., 2003).  
 
An evaluation of QoL using a total score is different from a global rating of QoL (Ferrans, 
2007). For the purpose of this study, both the total and global QoL will be assessed. The 
score of the single item of GF-7 in the functional domain of the FACT-G will be used to 
evaluate the global assessment of QoL, which explicitly asks the patient to rate the extent 
of contentment to current QoL. In prior studies, GF-7 demonstrated a significant 
relationship with overall QoL pinpointing the four specific domains (Brady et al., 1999; 
Whitford et al., 2008) (Appendix E).  
 
Checklist of Intervention Implementation 
Due to the exploratory nature of the trial, patients’ feedback to the intervention as well as 
the variables to be controlled (as evidence of intervention fidelity) will be collected in the 
checklist of the implementation of the intervention. The checklist (Appendix F) contains 
questions about the extent to which they felt the writing had helped them affirm their 
important values and beliefs, as well as the start timing, duration, focus/topic as well as 
duration of the writing. 
 
In addition to the demographic information (Appendix G), as well as other health 
information (including medical conditions and cancer treatments) to be collected from the 
medical records, patients will be asked to rate the perceived threat (Parle et a., 1996) at 
the baseline whether and to what extent (on a 4-point scale) they viewed the cancer 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
6 
 
diagnosis as a threat. During each data collection meeting, participants will be asked to 
make global ratings of changes (GRC) (Jaeschke et al., 1989) in QoL and spiritual well-
being on the five-point response categories (Cella et al., 2002) at the scale and factor 
levels.  
 
Finally, it has been suggested that measuring the patients’ assessment of the importance 
of different life quality domains over time is one way to gather possible changes in attitude 
and values, and aid interpretation of the outcome changes (Rustøen et al., 2000). The 
importance ratings for each subscale of the FACT-G and the FACIT-Sp-12 will be 
collected at each data-collection meeting.  
 
Table 1 The schedule of administration of questionnaires 
 
FACIT-Sp-12, the 12-item Functional Assessment of Chronic illness Therapy-Spiritual Well-Being Scale; FACT-G, the Functional 
Assessment of Cancer Therapy-General; HADS, the Hospital Anxiety and Depression Scale; RSES, the Rosenberg Self-Esteem 
Scale. 
*including the original scale and the revised items (Please refer to the enclosed measures for details) 
**including the start time, duration, frequency and the focus/topic of the writing as well as the perceived helpfulness 
 
Additionally, an exit survey (Appendix H) will be used to capture the number of eligible patients who decline or refuse participation, 
lost to follow-up at any point of study, as well as reasons of the lost to follow-up and/or withdrawal. 
 
Note: data collections will occur at the above scheduled windows +/- 3 days. 
 
Risks and Benefits 
Although the aim of the writing assignment has been strictly focused on value/belief 
affirmation rather than emotion ventilation, it is possible that some subjects might still 
experience slight psychological distress during writing; every effort will be made to 
support subjects throughout their involvement in the study. In addition, subjects might find 
it burdensome to complete study outcome measures; the meetings with the researcher 
will be scheduled at the time and place convenient to the subjects and they will be given 
as much time as needed to complete measures comfortably. Subjects may also stop at 
any time and reschedule the data collection if they would like. It will be explained to 
subjects that they may withdraw from the study at any time without repercussions. 
Subjects identified with depression as evidenced by a total score of 15 or higher on the 
HADS, or a score of 7 or higher on the HADS depression subscale (Vodermaier & 
Millman, 2011) will be informed of their scores and encouraged to tell their physician how 
they are feeling. If they do not wish to inform their physician, they will be encouraged to 
use the psychosocial support resources available and/or accessible. 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
7 
 
There are no direct benefits for patients participating in this study. However, knowledge 
gained from the study may provide important information for examining whether and 
how this intervention works. This information may be used by clinicians in their care of 
patients with advanced cancer and may help researchers to develop interventions to 
help other patients. Ultimately, we hope this study will contribute to our understanding 
whether and how patients may overcome the challenges imposed by a newly diagnosed 
advanced cancer by themselves. 
 
Data Handling and Recordkeeping 
The PI will carefully monitor study procedures to protect the safety of research subjects, 
the quality of the data and the integrity of the study.   
We will do everything we can to protect participants’ privacy. Research data (including 
writings, if turned in) will be collected in a private place and stored in password-protected 
database that is held on a UAMS secure server. All hard copies of questionnaires and 
forms will be filed in locked file cabinets at a locked office. By signing the consent form, 
participants authorize the researcher to use the de-identified data for current and future 
data analyses. 
 
A study number (or code) rather than the subject’s name will be used on study records 
and databases for each study participant enrolled. The key that links the study numbers 
to the subjects will be securely stored in a password-protected database that is held on a 
UAMS secure server. All the data collected from participants will be strictly maintained as 
private and confidential throughout the entire study period and after the completion of the 
data analyses. Participants’ names and other facts that might point to the patients will not 
appear in any presentation or publications. When the results are published or discussed 
in conferences, no information will be included that reveals research subjects’ identity. 
 
At the conclusion of the study, the data will be retained and later destroyed in accordance 
with institutional policy. The anticipated future use of the data may include secondary 
analysis of the writings from the participants, qualitative as well as quantitative.  The key 
linking identifiers to the study numbers (or codes) will be destroyed after all the data 
analyses are completed. 
 
 
 
 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
8 
 
Data Analysis 
Specific Aim 1. 
 
a. Intervention fidelity and feedback from the participants 
 
Fidelity of treatment in outcome research requires assessment and confirmation of the 
implementation of the independent variable as well as careful definition and 
operationalization of the intervention (Moncher & Prinz, 1991). For the purpose of this 
study, evidence of treatment fidelity will be assessed in the following aspects: 1) 
whether writing occurred at least once and (if so,) lasted for a minimum of 20 minutes 
each week, 2) whether writing was connected with the cancer diagnosis, and finally 3) 
whether writing focused on affirming one’s fundamental values and beliefs. 
 
Due to the exploratory nature of the pilot study, both the variables to be explored (that is, 
allowed to vary and without definitions) and the intervention parameters to be controlled 
(as specified above) will be collected in a checklist of the implementation of the 
intervention (Appendix F). Specifically, the participants’ feedback on the start time, 
duration, frequency, the topic of the writing, helpfulness of the study as well as the 
potential improvement in design), will be requested along with their response to questions 
concerning the evidence of treatment implementation (including whether writing occurred, 
whether the minimum amount of writing duration/frequency, and the prescribed focus of 
the writing as well as the relevance to cancer diagnosis were met). 
 
 
b. Explore the intervention effects, calculate effect sizes of the outcome variables, and 
estimate the appropriate sample size for the main study. 
 
Mean changes in patients' self-esteem, spiritual well-being (at the scale and factor levels), 
anxiety and depressive symptoms as well as QOL (global, total score and each subscale) 
will be evaluated using regression models for longitudinal data (i.e., repeated measures 
analysis of variance). The importance ratings for each subscale of the FACT-G and the 
FACIT-Sp-12 will be collected during each data collection meeting to aid interpretation of 
the intervention effect. Perceived threat at baseline and disease progression at each 
follow-up data collection meeting will be analyzed as moderators for exploratory analysis; 
psychosocial counseling or other supportive therapy/service/treatment received will be 
included as covariates. SAS® software will be used to perform all the proposed analyses. 
For hypothesis testing, an alpha (α) of 0.05 will be selected. 
 
The standardized mean difference (Cohen’s d statistic), or effect size will be computed 
by dividing the mean change by the standard deviation (SD) at the baseline (Kazis et al., 
1989). In addition, raw score changes from baseline to follow-up will be assessed to 
interpret the clinical significance of the change by comparing with the established 
estimates of the minimal clinically important difference (MCID) (Jaeschke et al., 1989) for 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
9 
 
the FACT-G. Raw scores at the baseline and follow-up will be compared with the norm 
reference or thresholds for clinical consideration, if available in the literature. 
 
Although psychological adaptation seems to be fundamentally independent from 
diagnostic group (Cassileth et al., 1984), treatment modality may exert an effect on quality 
of life outcomes (Oates et al., 2014). The type of anticancer treatment patient received 
will be collected from the patient’s chart; analysis of intervention effect and change over 
time will take treatment modality (as well as the diagnostic groups) into consideration (in 
subgroup or post-hoc exploratory analysis). 
 
 
Specific Aim 2. Test the validity of the 12-item functional assessment of chronic 
illness therapy- spiritual well-being scale (FACIT-Sp-12), in its current and revised 
forms. 
To verify the understanding of the updated Factor items in the revised FACIT-Sp-12 and 
compare with the original scale, patients will be asked about their interpretation of the 
items in the Faith factor for both the original and revised scales (Schuman, 1966). 
 
Cronbach’s coefficient alpha will be computed to examine internal consistency reliability 
for both the revised and the original FACIT-Sp-12. The homogeneity of the total scale and 
three factors of Meaning, Peace and Faith will be examined by the mean inter-item 
correlations, item-total correlations and item-rest correlations for both the original and 
revised FACIT-Sp-12. Construct validity will be explored by assessing the associations of 
the FACIT-Sp-12 (original and revised) with QoL (global and total FACT-G), self-esteem, 
and psychological distress (anxiety and depression). 
 
The threshold for the clinically important difference for the FACIT-Sp-12 at the scale and 
factor levels has not yet been reported in the literature. In this study, the MCIDs for scores 
of the scales and subscales from both the original and the revised FACIT-Sp-12 will be 
estimated using the criterion of global ratings of changes (GRC) on the five-point 
response categories (Cella et al., 2002). 
 
In addition, to examine whether the associations between the individual items and any 
sample characteristic may differ, which could suggest item bias or differential item 
functioning (Groenvold, Bjorner, Klee, & Kreiner, 1995), the validities of the FACIT-Sp-12 
concerning the Faith factor will be further examined with the differential item functioning 
analysis in both the original and the revised FACIT-Sp-12. 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and procedures. This 
protocol and any amendments will be submitted and approved by the IRB as required.   
 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
10 
 
Participants will receive $25 in compensation for their time and effort at the end of each 
data collection meeting (a total of $100 if the patient completes baseline and all the three 
follow-up data collections). 
The informed consent of each subject, using IRB-approved consent materials, will be 
obtained before that subject begins any study procedures.  All subjects for this study will 
be provided a consent form on paper describing this study in language understandable 
to the study population. Consent materials will provide sufficient information for subjects 
to make an informed decision about their participation in this study.  The person obtaining 
consent will thoroughly explain what the subjects need to know about the study, including 
study requirements, study risks and benefits. The consent process will take place in a 
designated office for research at the study sites. The consent discussion will occur right 
before the planned study participation. Participation privacy will be maintained and 
questions regarding participation will be answered.  No coercion or undue influence will 
be used in the consent process. This consent form must be signed by the subject and the 
person obtaining the consent. The participant will receive a copy of the signed consent 
form, and the informed consent process will be documented in the research record.  
The consent process will be documented separately via a written note in the research or 
medical chart for each subject. 
The study involves protected health information (PHI) as described in this protocol. 
Plans to protect identifiers are described in the Data Handling and Recordkeeping 
section. A partial HIPAA wavier for recruitment purposes is requested in order for PHI to 
be accessed/used for screening purposes.  
 
 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to a 
participant.   
 
 
 

Title:  Self-affirmation intervention for people newly diagnosed with advanced cancer: A preliminary 
efficacy trial 
PI: Mei Bai 
 
11 
 
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FACIT-Sp-12 
English (Universal) 
 
 
Copyright 1987, 1997                                                                                                                                                                                                                                                           Version #2 Date: May 9, 2022 
 
 
Below is a list of statements that other people with your illness have said are important. Please circle 
or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
 
Not at 
all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
 
Sp1 
I feel peaceful ......................................................................
0 
1 
2 
3 
4 
Sp2 
I have a reason for living .....................................................
0 
1 
2 
3 
4 
Sp3 
My life has been productive ................................................
0 
1 
2 
3 
4 
Sp4 
I have trouble feeling peace of mind ...................................
0 
1 
2 
3 
4 
Sp5 
I feel a sense of purpose in my life......................................
0 
1 
2 
3 
4 
Sp6 
I am able to reach down deep into myself for comfort .......
0 
1 
2 
3 
4 
Sp7 
I feel a sense of harmony within myself .............................
0 
1 
2 
3 
4 
Sp8 
My life lacks meaning and purpose.....................................
0 
1 
2 
3 
4 
Sp9 
I find comfort in my faith or spiritual beliefs ......................
0 
1 
2 
3 
4 
Sp10 
I find strength in my faith or spiritual beliefs......................
0 
1 
2 
3 
4 
Sp11 
My illness has strengthened my faith or spiritual beliefs ....
0 
1 
2 
3 
4 
Sp12 
I know that whatever happens with my illness, things 
will be okay .........................................................................
 
0 
 
1 
 
2 
 
3 
 
4 
 
ID # 
Visit Date: 

FACIT-Sp-12 Rev.* 
English (Universal) 
 
 
Copyright 1987, 1997 
 
Version #2 Date: May 9, 2022 
 
 
 
Below is a list of statements that other people with your illness have said are important. Please circle 
or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
 
Not at 
all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
 
Sp1 
I feel peaceful .....................................................................
0 
1 
2 
3 
4 
Sp2 
I have a reason for living ....................................................
0 
1 
2 
3 
4 
Sp3 
My life has been productive ...............................................
0 
1 
2 
3 
4 
Sp4 
I have trouble feeling peace of mind ..................................
0 
1 
2 
3 
4 
Sp5 
I feel a sense of purpose in my life ....................................
0 
1 
2 
3 
4 
Sp6 
I am able to reach down deep into myself for comfort ......
0 
1 
2 
3 
4 
Sp7 
I feel a sense of harmony within myself ............................
0 
1 
2 
3 
4 
Sp8 
My life lacks meaning and purpose ...................................
0 
1 
2 
3 
4 
Sp9a 
I find comfort in my fundamental values or beliefs ...........
0 
1 
2 
3 
4 
Sp10a 
I find strength in my fundamental values or beliefs ...........
0 
1 
2 
3 
4 
Sp11a 
My illness has strengthened my fundamental values or 
beliefs .................................................................................
0 
1 
2 
3 
4 
Sp12 
I know that whatever happens with my illness, things 
will be okay ........................................................................
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*revised with permission  
 
 
 
 
 
 
 
 
   ID # 
   Visit Date: 

RSES 
 
Below is a list of statements dealing with your general feelings about yourself.  
If you strongly agree, please circle SA. If you agree with the statement, please circle A.  
If you disagree, please circle D. If you strongly disagree, please circle SD. 
 
1 
 
 On the whole, I am satisfied with myself.  
SA 
A D SD 
2 
 
 At times, I think I am no good at all.  
SA 
A D SD 
3 
 
 I feel that I have a number of good qualities.  
SA 
A D SD 
4 
 
 I am able to do things as well as most other people.  
SA 
A D SD 
5 
 
 I feel I do not have much to be proud of.  
SA 
A D SD 
6 
 
 I certainly feel useless at times.  
SA 
A D SD 
7 
 
 I feel that I’m a person of worth, at least on an equal plane with others.  
SA 
A D SD 
8 
 
 I wish I could have more respect for myself.  
SA 
A D SD 
9 
 
 All in all, I am inclined to feel that I am a failure.  
SA 
A D SD 
10 
 
 I take a positive attitude toward myself.  
SA 
A D SD 
 
 
 
 
 
 
 
 
 
 
 
 
Version #2 
 
 
ID # 
Date: May 9, 2022 
 
 
Visit Date: 

HADS 
 
Below are statements describing feelings you may be having. 
 
Think about what each statement says, then fill in the bubble that most closely indicates how you have been 
feeling this past week. Please fill in one bubble for each item. 
 
 
1) I feel tense or 'wound up': 
○ 
○ 
○ 
○ 
Most of the time 
A lot of the time 
From time to time, 
occasionally 
Not at all 
 
 
2) I still enjoy the things I used to enjoy: 
○ 
○ 
○ 
○ 
Definitely as much 
Not quite so much 
Only a little 
Hardly at all 
 
 
3) I get a sort of frightened feeling as if something awful is about to happen: 
○ 
○ 
○ 
○ 
Very definitely and 
quite badly 
Yes, but not too badly 
A little, but it doesn't 
worry me 
Not at all 
 
 
 
4) I can laugh and see the funny side of things: 
○ 
○ 
○ 
○ 
As much as I always could 
Not quite so much now 
Definitely not so much now 
Not at all 
 
 
5) Worrying thoughts go through my mind: 
○ 
○ 
○ 
○ 
A great deal of the time 
A lot of the time 
From time to time, 
but not too often 
Only occasionally 
 
 
6) I feel cheerful: 
○ 
○ 
○ 
○ 
Not at all 
Not often 
Sometimes 
Most of the time 
 
 
7) I can sit at ease and feel relaxed: 
○ 
○ 
○ 
○ 
Definitely 
Usually 
Not often 
Not at all 
 
 
 
 
 

8) I feel as if I am slowed down: 
○ 
○ 
○ 
○ 
Nearly all the time 
Very often 
Sometimes 
Not at all 
 
 
9) I get a sort of frightened feeling like 'butterflies' in the stomach: 
○ 
○ 
○ 
○ 
Not at all 
Occasionally 
Quite often 
Very often 
 
 
10) I have lost interest in my appearance: 
○ 
○ 
○ 
○ 
Definitely 
I don’t take as much care as 
I should 
I may not take quite as 
much care 
I take just as much care as 
ever 
 
 
11) I feel restless as if I have to be on the move: 
○ 
○ 
○ 
○ 
Very much indeed 
Quite a lot 
Not very much 
Not at all 
 
 
12) I look forward with enjoyment to things: 
○ 
○ 
○ 
○ 
As much as I ever did 
Rather less than I used to 
Definitely less than I used 
to 
Hardly at all 
 
 
 
13) I get sudden feelings of panic: 
○ 
○ 
○ 
○ 
Very often indeed 
Quite often 
Not very often 
Not at all 
 
 
14) I can enjoy a good book or radio or TV program: 
○ 
○ 
○ 
○ 
Often 
Sometimes 
Not often 
Very seldom 
 
 
 
 
 
 
Version #2 
 
 
ID# 
Date: May 9, 2022 
 
       
Visit Date: 

FACT-G 
English (Universal) 
 
 
Copyright 1987, 1997                                                                                                                                                                                                                                                           Version #2 Date: May 9, 2022 
 
 
Below is a list of statements that other people with your illness have said are important. Please circle 
or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
 
PHYSICAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite
a bit 
Very 
much 
 
GP1 
I have a lack of energy .......................................................
0 
1 
2 
3 
4 
GP2 
I have nausea ......................................................................
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble 
meeting the needs of my family .........................................
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have pain ..........................................................................
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment .........................
0 
1 
2 
3 
4 
GP6 
I feel ill ...............................................................................
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed ........................................
0 
1 
2 
3 
4 
 
 
SOCIAL/FAMILY WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite
a bit 
Very 
much 
 
GS1 
I feel close to my friends ....................................................
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family ............................
0 
1 
2 
3 
4 
GS3 
I get support from my friends .............................................
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness ....................................
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness ..................................................................................
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person who is my main 
support) ..............................................................................
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual activity, please 
answer the following question. If you prefer not to answer it, 
please mark this box           and go to the next section. 
 
 
 
 
 
GS7 
I am satisfied with my sex life ............................................
0 
1 
2 
3 
4 

FACT-G 
English (Universal) 
 
 
Copyright 1987, 1997                                                                                                                                                                                                                                                           Version #2 Date: May 9, 2022 
 
 
Please circle or mark one number per line to indicate your response as it applies to the past 7 
days. 
 
 
 
EMOTIONAL WELL-BEING 
Not 
at all 
A little 
bit 
Some-
what 
Quite
a bit 
Very 
much 
 
GE1 
I feel sad ..............................................................................
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness ..........
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my illness ..................
0 
1 
2 
3 
4 
GE4 
I feel nervous .......................................................................
0 
1 
2 
3 
4 
GE5 
I worry about dying .............................................................
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse ............................
0 
1 
2 
3 
4 
 
 
 
 
FUNCTIONAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite
a bit 
Very 
much 
 
GF1 
I am able to work (include work at home) ..........................
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling .....................
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life ..........................................................
0 
1 
2 
3 
4 
GF4 
I have accepted my illness ...................................................
0 
1 
2 
3 
4 
GF5 
I am sleeping well ...............................................................
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun ......................
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now ..............
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 
ID # 
Visit Date: 
 

Checklist for the intervention implementation 
 
1. How frequently did you write?  
 
      ____________times per week 
 
2. How long on average did you write each time?  
 
      ____________minutes each time 
 
 
3. In a few words, please indicate what your writings focused on: 
 
    _______________________________________________________________________ 
 
4. Did you find the process putting thoughts to writing helpful? 
            very helpful             somewhat helpful        not sure           not very helpful 
 
    4a. If helpful, how did it help? 
 
        _______________________________________________________ 
 
    4b. If not helpful, what makes you think so? 
 
        ________________________________________________________ 
 
 
5. Do you think the timing of the writing as arranged in this study appropriate? 
 
      ______________________________________________________________ 
5a. Would it have helped more if you were able to write earlier? 
         ______________________________________________________ 
 
 
6. How much do you think writing is helpful for you to affirm or recall important values in your life? 
            very helpful             somewhat helpful        not sure           not very helpful 
 
 
7. Do you have any recommendation for how to make this writing intervention stronger? 
     _______________________________________________________________________ 
 
 
Version #2 
 
 
ID# 
Date: May 9, 2022 
 
 
Visit Date: 

Demographic Form 
 
 
Below are some basic questions that are related to this study. We appreciate you answer them to the best of your 
knowledge. Please write down your responses or circle answers that fit. 
 
 
1. What is your sex/gender?                
Male                 Female 
2. What is your Age? _______________ 
3. What is the date that you were informed of the diagnosis? ________________ 
4. Are you Hispanic or Latino?                
   No                  Yes 
5. What is your race? ___________ (White, African American, Asian, American Indian, Other) 
6. What is your current marital/relationship status?  (singe/never married, married, divorced, widowed) 
 
 
7. What is your highest grade of school completed (up to 8th grade, high school, college, graduate school) 
 
 
8. What is your religious affiliation? (None, Protestant, Catholic, Jewish, Muslim, Other) 
 
8a. Do you practice your religion? (no, occasionally, about weekly, daily) 
 
    8b. Do you think being spiritual must have a religious affiliation to associate?          No             Yes      
 
 
9. Do you prefer to talk about your cancer diagnosis with others, or not to talk? ____ (no/yes/not sure) 
 
 
10. Have you received or are seeking psychosocial counseling or other supportive therapy/service/treatment? 
 
                                                                                                                  No             Yes    
 
 
11. Have you ever put thoughts in your diary during stressful time in life?  ____ (no/yes) 
12. Would you please indicate your preference for filling out questionnaires in this study?       
       
           paper and pencil   
    iPad tablet      
read aloud by the investigator          other (please specify)         
 
 
Version #3 
 
 
ID # 
Date: May 9, 2022 
 
 
Visit Date: 

Exit Survey 
 
We understand that you are unable to participate in this study at this time and we fully respect your decision. If 
possible, would you please circle the reason(s) for declining participation in the study? This will help the 
investigator further improve the study. Thank you in advance for your time. 
 
1 
Too busy to participate; lack of time 
2 
Too tired to participate 
3 
Not interested 
4 
Other reason* 
 
*If you chose to decline participation for other reasons, please specify below the specific reason. Thank You. 
 
_______________________________________________________________________  
 
_______________________________________________________________________  
 
_______________________________________________________________________  
 
_______________________________________________________________________  
 
 
 
 
 
 
 
 
 
 
Version #2 
 
 
ID # 
Date: May 9, 2022 
 
 
Visit Date: