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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Young Adult Cancer; Body Image; Adolescent Cancer

Treatments: Other: BI Focused writing; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06046014

UMCC 2023.079

HUM00239179 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 15 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Expressive Writing (EW)

Experimental group

Description:

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

Treatment:

Other: BI Focused writing

Attention Control

Active Comparator group

Description:

four- week control writing program

Treatment:

Other: Control