Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors

Determining the Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors

Each year, about 89,500 adolescents and young adults (AYAs; 15-39 years old) are diagnosed with cancer and up to 60% experience body image (BI) distress. BI is largely developed in adolescence and young adulthood and has implications for self-identity and quality of life. Cancer itself and its associated treatments precipitate changes to appearance as well as body sensation and function, all of which can alter BI and lead to increased anxiety. An in-home BI-focused expressive writing (EW) program offers a promising outlet for addressing BI distress and anxiety in a way that eliminates constraints of clinical time and specialist availability.

There are no recommended interventions to help AYA cancer survivors cope with BI distress. To address this knowledge gap, the objective of this this pilot randomized-controlled trial is to determine the feasibility of a four-week BI-focused EW intervention to decrease BI distress and anxiety among AYA cancer survivors with the hypothesis that this intervention will reduce BI distress and anxiety.

Study Overview

• Status: Not yet recruiting
• Conditions: Body Image; Adolescent Cancer; Young Adult Cancer
• Intervention / Treatment: Other: BI Focused writing; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Wytiaz, MD; Phone Number: 412-908-3835; Email: wytiazv@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
      • Contact: Victoria Wytiaz, MD; Phone Number: 412-908-3835; Email: wytiazv@umich.edu
      • Principal Investigator: Victoria Wytiaz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 15-39 years
• History of one or more cancer diagnoses with all treatment (surgery, chemotherapy, radiation) completed ≥ 3 months before enrollment)
• BIS ≥10 at time of screening
• Ability to provide consent or assent and parental consent if applicable.

Exclusion Criteria:

• Plan to receive surgery, radiation, chemotherapy (including biologic agents, immunotherapy, and other targeted agents) for cancer treatment during the study period (from baseline assessment through post-four-week assessments and interview). Participants may continue with surveillance (such as imaging or biopsies) during the study period.
• Initiation of new treatments for body image distress or anxiety (e.g., pharmacologic, psychotherapy) ≤8 weeks prior to study enrollment. Although, participants may continue psychosocial or pharmacological treatments for anxiety or body image distress if the treatment were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant body image distress.
• History of limb-altering surgery or amputation (surgical exclusions are based on the premise that significant appearance-altering surgeries may impact body image distress differently than other cancer therapies)
• Currently receiving end-of-life care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expressive Writing (EW); four- week, in- home, Body Image (BI)- focused EW intervention	Other: BI Focused writing; BI Focused writing program
Active Comparator: Attention Control; four- week control writing program	Other: Control; Attention Control Writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of in-home Body Image (BI) -focused expressive writing (EW) intervention for post-treatment adolescent and young adult (AYA) cancer survivors with BI distress (recruitment)	percent of patients recruited within 6 months	7 months
Feasibility of in-home Body Image (BI) -focused expressive writing (EW) intervention for post-treatment adolescent and young adult (AYA) cancer survivors with BI distress (adherence)	percent of patients who complete the baseline and four week patient reported measures. 50% of participants complete 3 out of 4 (75%) of the at-home writing interventions.	7 months
Feasibility of in-home Body Image (BI) -focused expressive writing (EW) intervention for post-treatment adolescent and young adult (AYA) cancer survivors with BI distress (practicality)	75% of participants complete the baseline and four-week patient-reported measures	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale and score is reported as a calculated mean with higher scores indicating greater acceptability (no cut-off scores for interpretation are yet available). We will report descriptive statistics for this measure (mean and standard deviation) to quantitatively characterize perceive acceptability of the expressive writing intervention.	7 months
Facilitators and barriers of the intervention	Qualitative interviews will be transcribed by a professional HIPAA compliant transcription agency. The Study team will analyze interview data using inductive content analysis will read transcripts to derive codes, discuss labels to group codes into categories, and identify major themes and corresponding exemplar quotes.	7 Months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Victoria Wytiaz, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: expressive writing
• Other Study ID Numbers: UMCC 2023.079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No