Decision Aid for Education and Support About Cancer Treatment (DECIDES B+)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Childhood Cancer; Cancer

Treatments: Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT06191679

20-017521

Details and patient eligibility

About

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.

Full description

DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support application that has been designed to address health literacy and includes:

• 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

Enrollment: 117 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 3 patient groups

Usual Care

No Intervention group

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).

DECIDES with Informational Handout (DECIDES)

Experimental group

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.

Treatment:

Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)

DECIDES with Coach-Assisted Support (DECIDES+)

Experimental group

Description:

Subjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.

Treatment:

Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)