Effect of Group Led Creative Writing on Mood in Cancer Patients

NCT ID: NCT03536702

Last Updated: 2020-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2018-11-16

Brief Summary

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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

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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.

Conditions

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Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Creative Writing Workshop

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

Group Type EXPERIMENTAL

Creative Writing Workshop

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Independent Writing - Control Group

Intervention Type OTHER

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

Interventions

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Creative Writing Workshop

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

Intervention Type OTHER

Independent Writing - Control Group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Monika Joshi

Assistant Professor, Department of Medicine, Division of Hematology-Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Joshi, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Hershey Cancer Institute

Locations

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Penn State Cancer Institute

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PSCI 18-005

Identifier Type: -

Identifier Source: org_study_id

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