Adolescent Cancer, Body Image, Young Adult Cancer
Conditions
Keywords
expressive writing
Brief 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.
Detailed description
Protocol was updated to make the previous secondary outcome measures now exploratory
Interventions
OTHERBI Focused writing
BI Focused writing program
OTHERControl
Attention Control Writing
Sponsors
University of Michigan Rogel Cancer Center
American Society of Clinical Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months | percent of patients recruited within 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) | 7 months | percent of patients who completed both the baseline and four week patient reported measures and considered adherent to treatment |
| 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) | 7 months | 75% of participants complete the baseline and four-week patient-reported measures |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Wytiaz, MD
University of Michigan Rogel Cancer Center
Participant flow
Recruitment details
3 subjects enrolled, but were never randomized into an arm
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
None listed