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

NCT ID: NCT06046014

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-14
• Study Completion Date: 2025-06-01

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.

Detailed Description

Protocol was updated to make the previous secondary outcome measures now exploratory

Conditions

Adolescent Cancer; Young Adult Cancer; Body Image

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Expressive Writing (EW)

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

Group Type: EXPERIMENTAL

BI Focused writing

Intervention Type: OTHER

BI Focused writing program

Attention Control

four- week control writing program

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Attention Control Writing

Interventions

BI Focused writing

BI Focused writing program

Intervention Type: OTHER

Control

Attention Control Writing

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Wytiaz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00239179

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2023.079

Identifier Type: -

Identifier Source: org_study_id