Decision Aid for Education and Support About Cancer Treatment

NCT06191679 | Completed Results

• 1 other identifier: 20-017521
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Childhood Cancer

Keywords

AYA

Outcome Measures

Primary Outcomes (2)

• Acceptability of Decision Aid

  This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach.

  8 weeks post-randomization

• Usability of Decision Aid

  This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score \>80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and \<51 reflects letter grade "F" (adjective rating "awful").

  8 weeks post-randomization

Secondary Outcomes (8)

• Perceived Involvement in Shared Treatment Decision-Making Process

  8 weeks post-randomization

• Perceptions of Physician Engagement in Decision-Making Process

  8 weeks post-randomization

• Knowledge of Cancer Clinical Trials

  8-weeks post randomization

• Attitudes Toward Cancer Clinical Trials

  8 weeks post-randomization

• Uncertainty in Cancer Treatment Decision-Making Process

  8 weeks post-randomization

Study Arms (3)

Usual Care

NO INTERVENTION

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

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.

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

DECIDES with Coach-Assisted Support (DECIDES+)

EXPERIMENTAL

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

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

Interventions

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

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+); DECIDES with Informational Handout (DECIDES)

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Parent or Legal Guardian of a participating AYA
• Ability to read and speak English
• 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 involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)
• Ability to read and speak English
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 40584145 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Decision Support Techniques; Educational Status

Intervention Hierarchy (Ancestors)

Investigative Techniques; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Oncology Clinicians were not randomized to an intervention arm and did not participate in the intervention. Oncology Clinicians were enrolled to review DECIDES (live) during a semi-structured qualitative interview held via videoconference. Oncology Clinicians completed a measure of usability (Systems Usability Scale) during the interview. No other data were collected from Oncology Clinicians, including demographic data.

Results Point of Contact

• Title: Shannon Hammer
• Organization: Children's Hospital of Philadelphia

bresslers@chop.edu

2678878580

Study Officials

• Lamia Barakat, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: July 8, 2020
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)