An interventional study of Creative Writing Workshop and Independent Writing - Control Group in Cancer Patients, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
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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
The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.
Other: Creative Writing Workshop
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 participate in a writing workshop in group sessions.
This group will receive a book for a self writing session.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: 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.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 4 months
Status of Cancer at Consent
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Time frame: consent
Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Time frame: 4 months
Number of Subject That Were Not Hospital or ER Admissions After Study
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
Time frame: 4 months
Number of Emergency Room Visits and Hospitalizations Per Subject
Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group
Time frame: 4 months
Status of Cancer at End of Study
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Time frame: 4 months
Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time
Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group
Time frame: 4 months
| Milestone | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Started | 40 | 20 |
| Completed | 26 | 8 |
| Not completed | 14 | 12 |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Subscale 1- Distress at Final | 0 (0 to 4) | 1.5 (0 to 4.5) |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Subscale 2 - Anxiety at Final | 1 (0 to 6) | 2.5 (1 to 7) |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Subscale 3 - Depression at Final | 0 (0 to 6) | 2 (0 to 7) |
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..
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Subscale 4-anger at Final | 0 (0 to 4) | 1.5 (0 to 5) |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Subscale 5-need Help at Final | 0 (0 to 6) | 0.5 (0 to 3) |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Emotional Thermometer Score (Total) at Final | 2 (0 to 25) | 9.5 (2 to 21) |
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Depression Symptoms | 3 (0 to 18) | 3 (1 to 16) |
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.
Results for this outcome have not been posted.
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.
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Self Reported Somatic Symptoms at Final | 7 (1 to 16) | 5 (1 to 20) |
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
| units on a scale | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Depression Symptoms at Final | 3 (0 to 18) | 3 (1 to 16) |
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
| Participants | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Cured | 2 | 1 |
| New | 10 | 2 |
| Progression | 5 | 0 |
| Stable | 9 | 5 |
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
| Participants | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time | 5 | 0 |
Difference in number of emergency room visits and hospitalizations during study period between control and intervention group
| Participants | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Number of Subject That Were Not Hospital or ER Admissions After Study | 20 | 4 |
Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group
| ER visits and hospitalizations | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Number of Emergency Room Visits and Hospitalizations Per Subject | 6 | 4 |
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
| Participants | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| stable | 18 | 5 |
| Progression | 8 | 3 |
Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group
| Participants | Creative Writing Workshop | Independent Writing - Control Group |
|---|---|---|
| Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time | 21 | 8 |
Collected over up to 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Creative Writing Workshop | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Independent Writing - Control Group | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
Following the Intention-to-treat (ITT) principle, we report the status of all the 60 consented participants, who have been randomized with 1:2 ratio to two groups (control and intervention). Of those 60, 34 completed the baseline measures and took one class.
| Age, Continuous(years) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Mean | 63.2 ± 10.8 | 57.8 ± 10.1 | 61.9 ± 10.8 |
| Sex: Female, Male(Participants) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Female | 18 | 4 | 22 |
| Male | 8 | 4 | 12 |
| Race (NIH/OMB)(Participants) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 25 | 7 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Mood Score Baseline Emotional Thermometer Scale subscale 1-distress(units on a scale) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Median | 2 (0 to 6.5) | 2 (0 to 5) | 2 (0 to 6.5) |
| Emotional Thermometer subscale 2- anxiety baseline(units on a scale) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Median | 4 (0 to 10) | 5.5 (1 to 8) | 4 (0 to 10) |
| Emotional Thermometer subscale 3- depression baseline(units on a scale) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Median | 1 (0 to 9) | 3 (0 to 8) | 1.2 (0 to 9) |
| Emotional Thermometer subscale 4- anger baseline(units on a scale) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Median | 0.2 (0 to 7) | 2.5 (0 to 10) | 0.5 (0 to 10) |
| Emotional Thermometer subscale 5- need help baseline(units on a scale) | Creative Writing Workshop | Independent Writing - Control Group | Total |
|---|---|---|---|
| Median | 1 (0 to 7) | 1.5 (0 to 8) | 1 (0 to 8) |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Milton S. Hershey Medical Center