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

NCT06046014 | Completed

• 2 other identifiers: UMCC 2023.079HUM00239179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Cancer; Young Adult Cancer; Body Image

Keywords

expressive writing

Outcome Measures

Primary Outcomes (3)

• 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

Other Outcomes (2)

• Acceptability of Intervention

  7 months

• Facilitators and barriers of the intervention

  7 Months

Study Arms (2)

Expressive Writing (EW)

EXPERIMENTAL

four- week, in- home, Body Image (BI)- focused EW intervention

Other: BI Focused writing

Attention Control

ACTIVE COMPARATOR

four- week control writing program

Other: Control

Interventions

BI Focused writing OTHER

BI Focused writing program

Expressive Writing (EW)

Control OTHER

Attention Control Writing

Attention Control

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Currently receiving end-of-life care

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Victoria Wytiaz, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 14, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)