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

Body Image Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046014
• Other study ID #: UMCC 2023.079
• Secondary ID: HUM00239179
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Victoria Wytiaz, MD
• Phone: 412-908-3835
• Email: wytiazv[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Cancer
• Body Image
• Young Adult Cancer

Intervention

Other:
• BI Focused writing
BI Focused writing program
• Control
Attention Control Writing

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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