Clinical trial · Interventional
Decision Aid for Education and Support About Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Subjects will not receive the intervention and will only receive standard of care (i.e., subjects will access their health care team for decision support, per usual).
- type
- EXPERIMENTAL
- label
- DECIDES with Informational Handout (DECIDES)
- description
- Subjects will receive access to the decision support intervention (DECIDES) along with an informational handout that includes goals of the decision support intervention and instructions for accessing the web-based application independently.
- interventionNames
- Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
- type
- EXPERIMENTAL
- label
- DECIDES with Coach-Assisted Support (DECIDES+)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Adolescent and Young Adults (AYA) 1. 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) 2. 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 1. INCLUSION CRITERIA: * Parent or Legal Guardian of a participating AYA * Ability to read and speak English 2. 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 1. INCLUSION CRITERIA: * Oncology clinician involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s) * Ability to read and speak English 2. 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
References
Publications (1)
- DERIVEDBarakat LP, Hammer SN, Wen Y, Anil A, Schwartz LA, Reilly A, Bagatell R, Schapira MM, Li Y, Deatrick JA. Evaluation of a Decision Support Intervention for Adolescents and Young Adults Newly Diagnosed with Cancer: A Pilot Randomized Trial. MDM Policy Pract. 2025 Jun 26;10(1):23814683251344624. doi: 10.1177/23814683251344624. eCollection 2025 Jan-Jun. PMID 40584145