Trial Outcomes & Findings for Effect of Group Led Creative Writing on Mood in Cancer Patients (NCT NCT03536702)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

4 months

Results posted on

2020-10-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Creative Writing Workshop 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.	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. Independent Writing - Control Group: This group will receive a book for a self writing session.
Overall Study STARTED	40	20
Overall Study COMPLETED	26	8
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Group Led Creative Writing on Mood in Cancer Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Subscale 1- Distress at Final	0 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 4.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Subscale 2 - Anxiety at Final	1 units on a scale Interval 0.0 to 6.0	2.5 units on a scale Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Subscale 3 - Depression at Final	0 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 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..

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Subscale 4-anger at Final	0 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Subscale 5-need Help at Final	0 units on a scale Interval 0.0 to 6.0	0.5 units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Emotional Thermometer Score (Total) at Final	2 units on a scale Interval 0.0 to 25.0	9.5 units on a scale Interval 2.0 to 21.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=21 Participants 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.	Independent Writing - Control Group n=5 Participants 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.
Depression Symptoms	3 units on a scale Interval 0.0 to 18.0	3 units on a scale Interval 1.0 to 16.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=22 Participants 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.	Independent Writing - Control Group n=5 Participants 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.
Self Reported Somatic Symptoms at Final	7 units on a scale Interval 1.0 to 16.0	5 units on a scale Interval 1.0 to 20.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=21 Participants 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.	Independent Writing - Control Group n=5 Participants 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.
Depression Symptoms at Final	3 units on a scale Interval 0.0 to 18.0	3 units on a scale Interval 1.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: consent

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Status of Cancer at Consent Progression	5 Participants	0 Participants
Status of Cancer at Consent Cured	2 Participants	1 Participants
Status of Cancer at Consent New	10 Participants	2 Participants
Status of Cancer at Consent Stable	9 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time	5 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Number of Subject That Were Not Hospital or ER Admissions After Study	20 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Number of Emergency Room Visits and Hospitalizations Per Subject	6 ER visits and hospitalizations	4 ER visits and hospitalizations

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Status of Cancer at End of Study stable	18 Participants	5 Participants
Status of Cancer at End of Study Progression	8 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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.
Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time	21 Participants	8 Participants

Adverse Events

Creative Writing Workshop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Independent Writing - Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Monika Joshi, MD, MRCP

MS Hershey Medical Center

Phone: 717-531-8678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Creative Writing Workshop n=26 Participants 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.	Independent Writing - Control Group n=8 Participants 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 n=34 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	57.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	61.9 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	7 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mood Score Baseline Emotional Thermometer Scale subscale 1-distress	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants
Emotional Thermometer subscale 2- anxiety baseline	4 units on a scale n=5 Participants	5.5 units on a scale n=7 Participants	4 units on a scale n=5 Participants
Emotional Thermometer subscale 3- depression baseline	1 units on a scale n=5 Participants	3 units on a scale n=7 Participants	1.2 units on a scale n=5 Participants
Emotional Thermometer subscale 4- anger baseline	0.2 units on a scale n=5 Participants	2.5 units on a scale n=7 Participants	0.5 units on a scale n=5 Participants
Emotional Thermometer subscale 5- need help baseline	1 units on a scale n=5 Participants	1.5 units on a scale n=7 Participants	1 units on a scale n=5 Participants
Emotional Thermometer score (total) at baseline	2 units on a scale n=5 Participants	9.5 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Self Reported Somatic Symptoms baseline	7 units on a scale n=5 Participants	7 units on a scale n=7 Participants	7 units on a scale n=5 Participants
Depression Symptoms baseline	3 units on a scale n=5 Participants	4 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Anxiety Symptoms baseline	3 units on a scale n=5 Participants	3 units on a scale n=7 Participants	3 units on a scale n=5 Participants