Effect of Group Led Creative Writing on Mood in Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Group Led Creative Writing on Mood in Cancer Patients

Conditions
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Cancer Patients

Intervention / Treatment
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* Other: Creative Writing Workshop
* Other: Independent Writing - Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creative Writing Workshop<br>The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. | Other: Creative Writing Workshop<br>* This group will participate in a writing workshop in group sessions.<br>|
| Active Comparator: Independent Writing - Control Group<br>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 for 3 months. | Other: Independent Writing - Control Group<br>* This group will receive a book for a self writing session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Thermometer Subscale 1- Distress at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score. | 4 months | 
| Emotional Thermometer Subscale 2 - Anxiety at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score. | 4 months | 
| Emotional Thermometer Subscale 3 - Depression at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.re. | 4 months | 
| Emotional Thermometer Subscale 4-anger at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.. | 4 months | 
| Emotional Thermometer Subscale 5-need Help at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score. | 4 months | 
| Emotional Thermometer Score (Total) at Final | Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.score. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Symptoms | Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points. | 4 months | 
| Anxiety Symptoms | Severity of anxiety symptoms before and after intervention between two groups. The validated anxiety questionnaire, the Generalized Anxiety Disorder - 7 Scale, will be used to predict changes. This includes 7 questions describing symptoms of generalized anxiety, asking individual patients to rate how much those symptoms have bothered the individual in the past two weeks, from a score of 0 (not at all) to 3 (nearly every day). The total of the scores will be used to represent anxiety symptoms score, with a minimum score of 0 and a maximum score of 21, with higher score representing increasing severity of anxiety. | 4 months | 
| Self Reported Somatic Symptoms at Final | Self-reported somatic symptoms pre and post intervention in two groups. We will use the Somatic Symptom Scale - 8 (SSS-8) to quantify somatic symptom burden. The scale is composed of 8 questions with options to choose a score of 0 (not at all) - 4 (very much) to describe degree of distress caused by individual somatic symptoms. A total of the 8 scores is used as a final value for the SSS-8, with higher scores indicating worse Somatic Symptom severity. | 4 months | 
| Depression Symptoms at Final | Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points | 4 months |