N/A
N=97
Decision Aid for Education and Support About Cancer Treatment
Cancer · Childhood Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06191679 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Acceptability of Decision Aid — 4.10; 4.06; 4.01; 4.13 Average Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention) (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Decision Aid |
4.10; 4.06; 4.01; 4.13 | — |
| PRIMARY Usability of Decision Aid |
75.96; 78.82; 79.72; 83.33; 86.98 | — |
| SECONDARY Perceived Involvement in Shared Treatment Decision-Making Process |
57.33; 69.91; 69.26; 69.63; 77.78; 73.06 | — |
| SECONDARY Perceptions of Physician Engagement in Decision-Making Process |
73.00; 92.31; 82.78; 76.67; 96.00; 95.00 | — |
| SECONDARY Knowledge of Cancer Clinical Trials |
87.60; 81.85; 80.47; 87.56; 88.00; 88.31 | — |
| SECONDARY Attitudes Toward Cancer Clinical Trials |
0.20; -0.15; 0.05; 0.03; 0.05; 0.33 | — |
| SECONDARY Uncertainty in Cancer Treatment Decision-Making Process |
25.63; 23.44; 24.18; 25.00; 13.13; 20.02 | — |
| SECONDARY Regret About Cancer Treatment Decision-Making Process |
40.50; 27.31; 23.95; 17.78; 28.00; 13.13 | — |
| SECONDARY Satisfaction With Cancer Treatment Decision-Making Process |
24.20; 25.23; 25.53; 24.89; 27.30; 26.44 | — |
| SECONDARY Self-confidence in Cancer Treatment Decision-Making Abilities |
80.00; 78.15; 80.86; 81.06; 94.77; 86.93 | — |
Summary
The goals of this clinical trial are to evaluate DECIDES, a web-based decision support application that provides education about cancer and cancer treatment and provides support to encourage adolescent and young adult (AYA) patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.
The main questions this study aims to answer are:
* Is DECIDES acceptable, usable, and feasible for AYA, caregivers, and oncology health care providers?
* Is DECIDES helpful for AYA, caregivers, and oncology health care providers that are making cancer treatment decisions together?
AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups: (1) Usual Care, (2) DECIDES, or (3) DECIDES+. Participants in 'Usual Care' will continue to have access to their oncology health care team for questions related to cancer and cancer treatment, as per usual standard of care. Participants in both 'DECIDES' and 'DECIDES+' groups will receive access to DECIDES, and those in 'DECIDES+' will receive additional live, coach-assisted support. After 8 weeks, AYA and caregivers will complete a follow-up questionnaire and those in the 'DECIDES' and 'DECIDES+' groups will complete a semi-structured qualitative interview. Oncology clinicians of participating AYA will be invited to participate in a semi-structured qualitative interview. Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES (with an informational handout vs. coach-assisted support) report more positive decision-making processes compared to those that receive standard of care.
Eligibility Criteria
Adolescent and Young Adults (AYA)
- INCLUSION CRITERIA:
- Ages 15-24 years old
- Newly diagnosed or relapsed with leukemia/lymphoma, solid tumor, or brain tumor within 6 weeks of enrollment
- Ability to read and speak English
- If <18 Years Old: Parental/guardian permission to participate (informed consent)
- EXCLUSION CRITERIA:
- Inability to read or speak English
- Pre-existing cognitive deficits (based on provider assessment) that result in impaired reading or decision-making capacity
- AYA is a ward of the state or any other agency, institution, or entity
- If <18 Years Old: No Parental/Guardian permission to participate (informed consent)
Caregivers
- INCLUSION CRITERIA:
- Parent or Legal Guardian of a participating AYA
- Ability to read and speak English
- EXCLUSION CRITERIA:
- Foster parent or child advocate (i.e., caregiver is not biological parent or legal guardian)
- Inability to read or speak English
Oncology Clinicians
- INCLUSION CRITERIA:
- Oncology clinician involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)
- Ability to read and speak English
- EXCLUSION CRITERIA:
- Oncology clinician that is not involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)
- Inability to read or speak English
Data sourced from ClinicalTrials.gov (NCT06191679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.