Effect of Group Led Creative Writing on Mood in Cancer Patients

NCT03536702 | Completed Results

• 1 other identifier: PSCI 18-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Patients

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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..

  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.

  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.

  4 months

Secondary Outcomes (4)

• Depression Symptoms

  4 months

• Anxiety Symptoms

  4 months

• Self Reported Somatic Symptoms at Final

  4 months

• Depression Symptoms at Final

  4 months

Other Outcomes (6)

• Status of Cancer at Consent

  consent

• Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time

  4 months

• Number of Subject That Were Not Hospital or ER Admissions After Study

  4 months

Study Arms (2)

Creative Writing Workshop

EXPERIMENTAL

The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.

Other: Creative Writing Workshop

Independent Writing - Control Group

ACTIVE COMPARATOR

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

Interventions

Creative Writing Workshop OTHER

This group will participate in a writing workshop in group sessions.

Creative Writing Workshop

Independent Writing - Control Group OTHER

This group will receive a book for a self writing session.

Independent Writing - Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• DOI: 10.1200/JCO.2017.35.31_suppl.178 Journal of Clinical Oncology 35, no. 31_suppl (November 2017) 178-178.

  RESULT

Related Links

• Abstract presented at Palliative Care Symposium 11/2017

Results Point of Contact

• Title: Monika Joshi, MD, MRCP
• Organization: MS Hershey Medical Center

muj14@psu.edu

717-531-8678

Study Officials

• Monika Joshi, MD

  Penn State Hershey Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, Division of Hematology-Oncology

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 25, 2018
• Study Start: March 28, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)