20 and older, any sex, with Cancer Patients. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Emotional Thermometer Subscale 1- Distress at FinalPrimary· 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.
Group
Value
95% CI
Creative Writing Workshop
0
0 – 4
Independent Writing - Control Group
1.5
0 – 4.5
Emotional Thermometer Subscale 2 - Anxiety at FinalPrimary· 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.
Group
Value
95% CI
Creative Writing Workshop
1
0 – 6
Independent Writing - Control Group
2.5
1 – 7
Emotional Thermometer Subscale 3 - Depression at FinalPrimary· 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.
Group
Value
95% CI
Creative Writing Workshop
0
0 – 6
Independent Writing - Control Group
2
0 – 7
Emotional Thermometer Subscale 4-anger at FinalPrimary· 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..
Group
Value
95% CI
Creative Writing Workshop
0
0 – 4
Independent Writing - Control Group
1.5
0 – 5
Emotional Thermometer Subscale 5-need Help at FinalPrimary· 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.
Group
Value
95% CI
Creative Writing Workshop
0
0 – 6
Independent Writing - Control Group
0.5
0 – 3
Emotional Thermometer Score (Total) at FinalPrimary· 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.
Group
Value
95% CI
Creative Writing Workshop
2
0 – 25
Independent Writing - Control Group
9.5
2 – 21
Depression SymptomsSecondary· 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.
Group
Value
95% CI
Creative Writing Workshop
3
0 – 18
Independent Writing - Control Group
3
1 – 16
Self Reported Somatic Symptoms at FinalSecondary· 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.
Group
Value
95% CI
Creative Writing Workshop
7
1 – 16
Independent Writing - Control Group
5
1 – 20
Depression Symptoms at FinalSecondary· 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
Group
Value
95% CI
Creative Writing Workshop
3
0 – 18
Independent Writing - Control Group
3
1 – 16
Status of Cancer at ConsentSecondary· consent
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Cured
Group
Value
95% CI
Creative Writing Workshop
2
Independent Writing - Control Group
1
New
Group
Value
95% CI
Creative Writing Workshop
10
Independent Writing - Control Group
2
Progression
Group
Value
95% CI
Creative Writing Workshop
5
Independent Writing - Control Group
0
Stable
Group
Value
95% CI
Creative Writing Workshop
9
Independent Writing - Control Group
5
Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study TimeSecondary· 4 months
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Group
Value
95% CI
Creative Writing Workshop
5
Independent Writing - Control Group
0
Number of Subject That Were Not Hospital or ER Admissions After StudySecondary· 4 months
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Group
Value
95% CI
Creative Writing Workshop
20
Independent Writing - Control Group
4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Milton S. Hershey Medical Center
Last refreshed: 20 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03536702.