N/A N=60 Randomized Supportive Care

Effect of Group Led Creative Writing on Mood in Cancer Patients

Cancer Patients

Bottom Line

View on ClinicalTrials.gov: NCT03536702 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Emotional Thermometer Subscale 1- Distress at Final — 0; 1.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Creative Writing Workshop (Other); Independent Writing - Control Group (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Emotional Thermometer Subscale 1- Distress at Final	0; 1.5	—
PRIMARY Emotional Thermometer Subscale 2 - Anxiety at Final	1; 2.5	—
PRIMARY Emotional Thermometer Subscale 3 - Depression at Final	0; 2	—
PRIMARY Emotional Thermometer Subscale 4-anger at Final	0; 1.5	—
PRIMARY Emotional Thermometer Subscale 5-need Help at Final	0; 0.5	—
PRIMARY Emotional Thermometer Score (Total) at Final	2; 9.5	—
SECONDARY Depression Symptoms	3; 3	—
SECONDARY Anxiety Symptoms	—	—
SECONDARY Self Reported Somatic Symptoms at Final	7; 5	—
SECONDARY Depression Symptoms at Final	3; 3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03536702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.