Cancer Patients
Conditions
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.
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.
Interventions
OTHERCreative Writing Workshop
This group will participate in a writing workshop in group sessions.
OTHERIndependent Writing - Control Group
This group will receive a book for a self writing session.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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.. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Status of Cancer at Consent | consent | Comparison of status of cancer (stable, progressing, in remission) between intervention and control group. |
| 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 |
| Status of Cancer at End of Study | 4 months | Comparison of status of cancer (stable, progressing, in remission) between intervention and control group. |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 8 |
| Total | 34 |
Baseline characteristics
| Characteristic | Independent Writing - Control Group | Creative Writing Workshop | Total |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 10.1 | 63.2 years STANDARD_DEVIATION 10.8 | 61.9 years STANDARD_DEVIATION 10.8 |
| Anxiety Symptoms baseline | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Depression Symptoms baseline | 4 units on a scale | 3 units on a scale | 3 units on a scale |
| Emotional Thermometer score (total) at baseline | 9.5 units on a scale | 2 units on a scale | 3 units on a scale |
| Emotional Thermometer subscale 2- anxiety baseline | 5.5 units on a scale | 4 units on a scale | 4 units on a scale |
| Emotional Thermometer subscale 3- depression baseline | 3 units on a scale | 1 units on a scale | 1.2 units on a scale |
| Emotional Thermometer subscale 4- anger baseline | 2.5 units on a scale | 0.2 units on a scale | 0.5 units on a scale |
| Emotional Thermometer subscale 5- need help baseline | 1.5 units on a scale | 1 units on a scale | 1 units on a scale |
| Mood Score Baseline Emotional Thermometer Scale subscale 1-distress | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 25 Participants | 32 Participants |
| Self Reported Somatic Symptoms baseline | 7 units on a scale | 7 units on a scale | 7 units on a scale |
| Sex: Female, Male Female | 4 Participants | 18 Participants | 22 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 8 |
| other Total, other adverse events | 0 / 26 | 0 / 8 |
| serious Total, serious adverse events | 0 / 26 | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Score (Total) at Final | 2 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Score (Total) at Final | 9.5 units on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Subscale 1- Distress at Final | 0 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Subscale 1- Distress at Final | 1.5 units on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Subscale 2 - Anxiety at Final | 1 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Subscale 2 - Anxiety at Final | 2.5 units on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Subscale 3 - Depression at Final | 0 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Subscale 3 - Depression at Final | 2 units on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Subscale 4-anger at Final | 0 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Subscale 4-anger at Final | 1.5 units on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Emotional Thermometer Subscale 5-need Help at Final | 0 units on a scale |
| Independent Writing - Control Group | Emotional Thermometer Subscale 5-need Help at Final | 0.5 units on a scale |
Secondary
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
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Depression Symptoms | 3 units on a scale |
| Independent Writing - Control Group | Depression Symptoms | 3 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Depression Symptoms at Final | 3 units on a scale |
| Independent Writing - Control Group | Depression Symptoms at Final | 3 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Creative Writing Workshop | Self Reported Somatic Symptoms at Final | 7 units on a scale |
| Independent Writing - Control Group | Self Reported Somatic Symptoms at Final | 5 units on a scale |
Other Pre-specified
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Creative Writing Workshop | Number of Emergency Room Visits and Hospitalizations Per Subject | 6 ER visits and hospitalizations |
| Independent Writing - Control Group | Number of Emergency Room Visits and Hospitalizations Per Subject | 4 ER visits and hospitalizations |
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Creative Writing Workshop | Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time | 5 Participants |
| Independent Writing - Control Group | Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time | 0 Participants |
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Creative Writing Workshop | Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time | 21 Participants |
| Independent Writing - Control Group | Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time | 8 Participants |
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Creative Writing Workshop | Number of Subject That Were Not Hospital or ER Admissions After Study | 20 Participants |
| Independent Writing - Control Group | Number of Subject That Were Not Hospital or ER Admissions After Study | 4 Participants |
Other Pre-specified
Status of Cancer at Consent
Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.
Time frame: consent
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Creative Writing Workshop | Status of Cancer at Consent | Cured | 2 Participants |
| Creative Writing Workshop | Status of Cancer at Consent | New | 10 Participants |
| Creative Writing Workshop | Status of Cancer at Consent | Progression | 5 Participants |
| Creative Writing Workshop | Status of Cancer at Consent | Stable | 9 Participants |
| Independent Writing - Control Group | Status of Cancer at Consent | Stable | 5 Participants |
| Independent Writing - Control Group | Status of Cancer at Consent | Cured | 1 Participants |
| Independent Writing - Control Group | Status of Cancer at Consent | Progression | 0 Participants |
| Independent Writing - Control Group | Status of Cancer at Consent | New | 2 Participants |
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Creative Writing Workshop | Status of Cancer at End of Study | stable | 18 Participants |
| Creative Writing Workshop | Status of Cancer at End of Study | Progression | 8 Participants |
| Independent Writing - Control Group | Status of Cancer at End of Study | stable | 5 Participants |
| Independent Writing - Control Group | Status of Cancer at End of Study | Progression | 3 Participants |