- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536702
Effect of Group Led Creative Writing on Mood in Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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This group will participate in a writing workshop in group sessions.
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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.
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This group will receive a book for a self writing session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional Thermometer Subscale 1- Distress at Final
Time Frame: 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.
|
4 months
|
Emotional Thermometer Subscale 2 - Anxiety at Final
Time Frame: 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.
|
4 months
|
Emotional Thermometer Subscale 3 - Depression at Final
Time Frame: 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 months
|
Emotional Thermometer Subscale 4-anger at Final
Time Frame: 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..
|
4 months
|
Emotional Thermometer Subscale 5-need Help at Final
Time Frame: 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.
|
4 months
|
Emotional Thermometer Score (Total) at Final
Time Frame: 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.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Symptoms
Time Frame: 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.
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4 months
|
Anxiety Symptoms
Time Frame: 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.
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4 months
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Self Reported Somatic Symptoms at Final
Time Frame: 4 months
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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.
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4 months
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Depression Symptoms at Final
Time Frame: 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
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Status of Cancer at Consent
Time Frame: consent
|
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
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consent
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Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time
Time Frame: 4 months
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Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
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4 months
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Number of Subject That Were Not Hospital or ER Admissions After Study
Time Frame: 4 months
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Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
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4 months
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Number of Emergency Room Visits and Hospitalizations Per Subject
Time Frame: 4 months
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Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group
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4 months
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Status of Cancer at End of Study
Time Frame: 4 months
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Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
|
4 months
|
Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time
Time Frame: 4 months
|
Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monika Joshi, MD, Penn State Hershey Cancer Institute
Publications and helpful links
General Publications
- DOI: 10.1200/JCO.2017.35.31_suppl.178 Journal of Clinical Oncology 35, no. 31_suppl (November 2017) 178-178.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSCI 18-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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