An interventional study of BI Focused writing and Control in Adolescent Cancer, Young Adult Cancer and Body Image, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Supportive care
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.
Protocol was updated to make the previous secondary outcome measures now exploratory
University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
four- week, in- home, Body Image (BI)- focused EW intervention
Other: BI Focused writing
four- week control writing program
Other: Control
BI Focused writing program
Attention Control Writing
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
Time frame: 6 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 completed both the baseline and four week patient reported measures and considered adherent to treatment
Time frame: 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
Time frame: 7 months
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.
Time frame: 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.
Time frame: 7 Months
3 subjects enrolled, but were never randomized into an arm
| Milestone | Expressive Writing (EW) | Attention Control |
|---|---|---|
| Started | 14 | 13 |
| Completed | 14 | 12 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
percent of patients recruited within 6 months
| Participants | Expressive Writing (EW) | Attention Control |
|---|---|---|
| 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) | 10 | 10 |
percent of patients who completed both the baseline and four week patient reported measures and considered adherent to treatment
| Participants | Expressive Writing (EW) | Attention Control |
|---|---|---|
| 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) | 12 | 11 |
75% of participants complete the baseline and four-week patient-reported measures
| Participants | Expressive Writing (EW) | Attention Control |
|---|---|---|
| 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) | 12 | 11 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Adverse events related to this study were not expected and none occurred. Subjects were monitored for 5 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Expressive Writing (EW) | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Attention Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Expressive Writing (EW) | Attention Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 13 | 27 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Expressive Writing (EW) | Attention Control | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Expressive Writing (EW) | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 5 | 12 |
| Unknown or Not Reported | 7 | 8 | 15 |
| Race (NIH/OMB)(Participants) | Expressive Writing (EW) | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 5 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 8 | 16 |
| Region of Enrollment(participants) | Expressive Writing (EW) | Attention Control | Total |
|---|---|---|---|
| United States | 14 | 13 | 27 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No plan to make individual participant data available to other researchers
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center