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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adolescent Cancer, Young Adult Cancer, Body Image

Intervention / Treatment
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* Other: BI Focused writing
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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expressive writing