Trial Outcomes & Findings for Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors (NCT NCT06046014)
NCT ID: NCT06046014
Last Updated: 2026-05-11
Results Overview
percent of patients recruited within 6 months
COMPLETED
NA
30 participants
6 months
2026-05-11
Participant Flow
3 subjects enrolled, but were never randomized into an arm
Participant milestones
| Measure |
Expressive Writing (EW)
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
four- week control writing program
Control: Attention Control Writing
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Expressive Writing (EW)
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
four- week control writing program
Control: Attention Control Writing
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors
Baseline characteristics by cohort
| Measure |
Expressive Writing (EW)
n=14 Participants
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
n=13 Participants
four- week control writing program
Control: Attention Control Writing
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=44 Participants
|
13 Participants
n=10 Participants
|
27 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=44 Participants
|
13 Participants
n=10 Participants
|
26 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=44 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=44 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=44 Participants
|
13 participants
n=10 Participants
|
27 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 monthspercent of patients recruited within 6 months
Outcome measures
| Measure |
Expressive Writing (EW)
n=14 Participants
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
n=13 Participants
four- week control writing program
Control: 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)
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 7 monthspercent of patients who completed both the baseline and four week patient reported measures and considered adherent to treatment
Outcome measures
| Measure |
Expressive Writing (EW)
n=14 Participants
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
n=13 Participants
four- week control writing program
Control: 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 (Adherence)
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 7 months75% of participants complete the baseline and four-week patient-reported measures
Outcome measures
| Measure |
Expressive Writing (EW)
n=14 Participants
four- week, in- home, Body Image (BI)- focused EW intervention
BI Focused writing: BI Focused writing program
|
Attention Control
n=13 Participants
four- week control writing program
Control: 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 (Practicality)
|
12 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 months4-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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 MonthsQualitative 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.
Outcome measures
Outcome data not reported
Adverse Events
Expressive Writing (EW)
Attention Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place