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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00239179 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| American Society of Clinical Oncology | OTHER |
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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.
Protocol was updated to make the previous secondary outcome measures now exploratory
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expressive Writing (EW) | Experimental | four- week, in- home, Body Image (BI)- focused EW intervention |
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| Attention Control | Active Comparator | four- week control writing program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI Focused writing | Other | BI Focused writing program |
| |
| 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 | 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 | 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 |
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| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Wytiaz, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
No plan to make individual participant data available to other researchers
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3 subjects enrolled, but were never randomized into an arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Expressive Writing (EW) | four- week, in- home, Body Image (BI)- focused EW intervention BI Focused writing: BI Focused writing program |
| FG001 | Attention Control | four- week control writing program Control: Attention Control Writing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2024 |
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| Control |
| Other |
Attention Control Writing |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Expressive Writing (EW) | four- week, in- home, Body Image (BI)- focused EW intervention BI Focused writing: BI Focused writing program |
| BG001 | Attention Control | four- week control writing program Control: Attention Control Writing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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 completed both the baseline and four week patient reported measures and considered adherent to treatment | Posted | Count of Participants | Participants | 7 months |
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| 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 | Posted | Count of Participants | Participants | 7 months |
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| Other Pre-specified | 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. | Not Posted | 7 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | 7 Months | Participants |
Adverse events related to this study were not expected and none occurred. Subjects were monitored for 5 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Expressive Writing (EW) | four- week, in- home, Body Image (BI)- focused EW intervention BI Focused writing: BI Focused writing program | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Attention Control | four- week control writing program Control: Attention Control Writing | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | clinicaltrialsgov_ccadmin@med.umich.edu |
| Apr 10, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2024 | Apr 10, 2026 | ICF_001.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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