Effect of Group Led Creative Writing on Mood in Cancer Patients

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03536702
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Patients	Other: Creative Writing Workshop; Other: Independent Writing - Control Group	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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)
• Primary Purpose: Supportive Care
• Official Title: Effect of Group Led Creative Writing on Mood in Cancer Patients
• Actual Study Start Date: Mar 28, 2018
• Actual Primary Completion Date: Nov 16, 2018
• Actual Study Completion Date: Nov 16, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Emotional Thermometer Subscale 1- Distress at Final [4 months]

   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.

2. Emotional Thermometer Subscale 2 - Anxiety at Final [4 months]

   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.

3. Emotional Thermometer Subscale 3 - Depression at Final [4 months]

   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. Emotional Thermometer Subscale 4-anger at Final [4 months]

   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..

5. Emotional Thermometer Subscale 5-need Help at Final [4 months]

   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.

6. Emotional Thermometer Score (Total) at Final [4 months]

   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.

Secondary Outcome Measures

1. Depression Symptoms [4 months]

   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.

2. Anxiety Symptoms [4 months]

   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.

3. Self Reported Somatic Symptoms at Final [4 months]

   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. Depression Symptoms at Final [4 months]

   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

Other Outcome Measures

1. Status of Cancer at Consent [consent]

   Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.

2. Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time [4 months]

   Difference in number of emergency room visits and hospitalizations during study period between control and intervention group

3. Number of Subject That Were Not Hospital or ER Admissions After Study [4 months]

   Difference in number of emergency room visits and hospitalizations during study period between control and intervention group

4. Number of Emergency Room Visits and Hospitalizations Per Subject [4 months]

   Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group

5. Status of Cancer at End of Study [4 months]

   Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.

6. Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time [4 months]

   Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Cancer Institute	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Monika Joshi, MD, Penn State Hershey Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 24, 2020

More Information

Additional Information:

• Abstract presented at Palliative Care Symposium 11/2017

Publications

None provided.

• Responsible Party: Monika Joshi, Assistant Professor, Department of Medicine, Division of Hematology-Oncology, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03536702
• Other Study ID Numbers: PSCI 18-005
• First Posted: May 25, 2018
• Last Update Posted: Oct 20, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	60 subjects signed consent. Results reported are for completers only. Completers are participants who signed consent, were randomized, completed baseline measures and took at least one class after baseline.

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Period Title: Overall Study
STARTED	40	20
COMPLETED	26	8
NOT COMPLETED	14	12

Baseline Characteristics

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group	Total
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.	Total of all reporting groups
Overall Participants	26	8	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (10.8)	57.8 (10.1)	61.9 (10.8)
Sex: Female, Male (Count of Participants)
Female	18 69.2%	4 50%	22 64.7%
Male	8 30.8%	4 50%	12 35.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.8%	1 12.5%	2 5.9%
White	25 96.2%	7 87.5%	32 94.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Mood Score Baseline Emotional Thermometer Scale subscale 1-distress (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	2	2	2
Emotional Thermometer subscale 2- anxiety baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	4	5.5	4
Emotional Thermometer subscale 3- depression baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	1	3	1.2
Emotional Thermometer subscale 4- anger baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	0.2	2.5	0.5
Emotional Thermometer subscale 5- need help baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	1	1.5	1
Emotional Thermometer score (total) at baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	2	9.5	3
Self Reported Somatic Symptoms baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	7	7	7
Depression Symptoms baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	3	4	3
Anxiety Symptoms baseline (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	3	3	3

Outcome Measures

1. Primary Outcome

Title	Emotional Thermometer Subscale 1- Distress at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	0	1.5

2. Primary Outcome

Title	Emotional Thermometer Subscale 2 - Anxiety at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	1	2.5

3. Primary Outcome

Title	Emotional Thermometer Subscale 3 - Depression at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	0	2

4. Primary Outcome

Title	Emotional Thermometer Subscale 4-anger at Final
Description	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..
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	0	1.5

5. Primary Outcome

Title	Emotional Thermometer Subscale 5-need Help at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	0	0.5

6. Primary Outcome

Title	Emotional Thermometer Score (Total) at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Median (Full Range) [units on a scale]	2	9.5

7. Secondary Outcome

Title	Depression Symptoms
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	21	5
Median (Full Range) [units on a scale]	3	3

8. Secondary Outcome

Title	Anxiety Symptoms
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Self Reported Somatic Symptoms at Final
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	22	5
Median (Full Range) [units on a scale]	7	5

10. Secondary Outcome

Title	Depression Symptoms at Final
Description	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
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	21	5
Median (Full Range) [units on a scale]	3	3

11. Other Pre-specified Outcome

Title	Status of Cancer at Consent
Description	Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Time Frame	consent

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Cured	2 7.7%	1 12.5%
New	10 38.5%	2 25%
Progression	5 19.2%	0 0%
Stable	9 34.6%	5 62.5%

12. Other Pre-specified Outcome

Title	Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time
Description	Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Count of Participants [Participants]	5 19.2%	0 0%

13. Other Pre-specified Outcome

Title	Number of Subject That Were Not Hospital or ER Admissions After Study
Description	Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Count of Participants [Participants]	20 76.9%	4 50%

14. Other Pre-specified Outcome

Title	Number of Emergency Room Visits and Hospitalizations Per Subject
Description	Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Number [ER visits and hospitalizations]	6	4

15. Other Pre-specified Outcome

Title	Status of Cancer at End of Study
Description	Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
stable	18 69.2%	5 62.5%
Progression	8 30.8%	3 37.5%

16. Other Pre-specified Outcome

Title	Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time
Description	Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creative Writing Workshop	Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Measure Participants	26	8
Count of Participants [Participants]	21 80.8%	8 100%

Adverse Events

Time Frame	up to 4 months
Arm/Group Title	Creative Writing Workshop		Independent Writing - Control Group
Arm/Group Description	The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months. Creative Writing Workshop: This group will participate in a writing workshop in group sessions.		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. Independent Writing - Control Group: This group will receive a book for a self writing session.
All Cause Mortality
	Creative Writing Workshop		Independent Writing - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/8 (0%)
Serious Adverse Events
	Creative Writing Workshop		Independent Writing - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Creative Writing Workshop		Independent Writing - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.