Clinical trial NCT06191679: Decision Aid for Education and Support About Cancer Treatment
Official title: Decision Aid for Education and Support About Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Childhood Cancer
Keywords: AYA
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 117
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Family Units (AYA and caregiver participants) are randomized to one of three arms:

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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Acceptability of Decision Aid
timeFrame: 8 weeks post-randomization
measure: Usability of Decision Aid
timeFrame: 8 weeks post-randomization
Secondary outcomes:
measure: Perceived Involvement in Shared Treatment Decision-Making Process
timeFrame: 8 weeks post-randomization
measure: Perceptions of Physician Engagement in Decision-Making Process
timeFrame: 8 weeks post-randomization
measure: Knowledge of Cancer Clinical Trials
timeFrame: 8-weeks post randomization
measure: Attitudes Toward Cancer Clinical Trials
timeFrame: 8 weeks post-randomization
measure: Uncertainty in Cancer Treatment Decision-Making Process
timeFrame: 8 weeks post-randomization
measure: Regret About Cancer Treatment Decision-Making Process
timeFrame: 8 weeks post-randomization
measure: Satisfaction With Cancer Treatment Decision-Making Process
timeFrame: 8 weeks post-randomization
measure: Self-confidence in Cancer Treatment Decision-Making Abilities
timeFrame: 8 weeks post-randomization
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lamia Barakat, PhD
role: PRINCIPAL_INVESTIGATOR
References: