Clinical trial NCT03536702: Effect of Group Led Creative Writing on Mood in Cancer Patients
Official title: Effect of Group Led Creative Writing on Mood in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 3 months.

Detailed description: Mental wellness before and after intervention in both arms. 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.

Eligibility criteria: Inclusion Criteria:

Newly diagnosed with any stage or type of cancer within 3 months OR progression of disease within 3 months of enrollment. Recurrence of cancer within 3 months of enrollment would also be eligible as it will be considered as progression of cancer Ability to understand English language and ability to write without any functional difficulty ECOG performance status 0-3

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

Primary outcomes:
measure: Emotional Thermometer Subscale 1- Distress at Final
timeFrame: 4 months
measure: Emotional Thermometer Subscale 2 - Anxiety at Final
timeFrame: 4 months
measure: Emotional Thermometer Subscale 3 - Depression at Final
timeFrame: 4 months
measure: Emotional Thermometer Subscale 4-anger at Final
timeFrame: 4 months
measure: Emotional Thermometer Subscale 5-need Help at Final
timeFrame: 4 months
measure: Emotional Thermometer Score (Total) at Final
timeFrame: 4 months
Secondary outcomes:
measure: Depression Symptoms
timeFrame: 4 months
measure: Anxiety Symptoms
timeFrame: 4 months
measure: Self Reported Somatic Symptoms at Final
timeFrame: 4 months
measure: Depression Symptoms at Final
timeFrame: 4 months
Other outcomes:
measure: Status of Cancer at Consent
timeFrame: consent
measure: Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time
timeFrame: 4 months
measure: Number of Subject That Were Not Hospital or ER Admissions After Study
timeFrame: 4 months
measure: Number of Emergency Room Visits and Hospitalizations Per Subject
timeFrame: 4 months
measure: Status of Cancer at End of Study
timeFrame: 4 months
measure: Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time
timeFrame: 4 months
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State Hershey Cancer Institute
name: Monika Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DOI: 10.1200/JCO.2017.35.31_suppl.178 Journal of Clinical Oncology 35, no. 31_suppl (November 2017) 178-178.