Decision Aid for Education and Support About Cancer Treatment
NCT ID: NCT06191679
Last Updated: 2025-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2020-07-08
2023-04-13
Brief Summary
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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.
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Detailed Description
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* Education on cancer and cancer treatments, including clinical trials
* An exercise to identify perceived barriers and benefits to treatment options
* An exercise to clarify personal goals for treatment that align with life goals
* Resources to support communication with the oncology health care team
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. No intervention (referred to as "Usual Care")
2. DECIDES with an informational handout (referred to as "DECIDES")
3. DECIDES with coach-assisted support (referred to as "DECIDES+")
Oncology Clinicians of participating AYA are not randomized to an intervention arm; they are enrolled to complete a singular Qualitative Interview to provide feedback for future implementation.
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Care
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).
No interventions assigned to this group
DECIDES with Informational Handout (DECIDES)
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.
Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support intervention for AYA diagnosed with cancer (and their caregivers) that includes components written for low health literacy. Components include:
* Education on cancer and cancer treatments, including clinical trials
* An exercise to identify perceived barriers and benefits to treatment options
* An exercise to clarify personal goals for treatment that align with life goals
* Resources to support communication with the oncology health care team
DECIDES with Coach-Assisted Support (DECIDES+)
Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support intervention for AYA diagnosed with cancer (and their caregivers) that includes components written for low health literacy. Components include:
* Education on cancer and cancer treatments, including clinical trials
* An exercise to identify perceived barriers and benefits to treatment options
* An exercise to clarify personal goals for treatment that align with life goals
* Resources to support communication with the oncology health care team
Interventions
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Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support intervention for AYA diagnosed with cancer (and their caregivers) that includes components written for low health literacy. Components include:
* Education on cancer and cancer treatments, including clinical trials
* An exercise to identify perceived barriers and benefits to treatment options
* An exercise to clarify personal goals for treatment that align with life goals
* Resources to support communication with the oncology health care team
Eligibility Criteria
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Inclusion Criteria
* 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)
* Parent or Legal Guardian of a participating AYA
* Ability to read and speak English
* Oncology clinician involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)
* Ability to read and speak English
Exclusion Criteria
* 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
* Foster parent or child advocate (i.e., caregiver is not biological parent or legal guardian)
* Inability to read or speak English
Oncology Clinicians
* 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
15 Years
24 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Lamia Barakat, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Barakat 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-017521
Identifier Type: -
Identifier Source: org_study_id
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