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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Childhood Cancer
• Intervention / Treatment: Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)

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

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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.	Behavioral: 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
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Involvement in Shared Treatment Decision-Making Process	The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process.	8 weeks post-randomization
Perceptions of Physician Engagement in Decision-Making Process	This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician.	8 weeks post-randomization
Knowledge of Cancer Clinical Trials	This is a 25-item true/false questionnaire used to assess participant understanding of clinical trials and informed consent processes. Items are scored based on % correct, with higher scores reflecting more knowledge.	8-weeks post randomization
Attitudes Toward Cancer Clinical Trials	This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Continuous scores were calculated from PRPQ items reflecting 'Perceived Benefits' (with a higher score suggesting positive attitudes) and from PRPQ items reflecting 'Perceived Barriers' (with a higher score suggesting negative attitudes). A 'Decision Balance' score was computed by converting the 'Perceived Benefits' and 'Perceived Barriers' scores to Z-scores, and then subtracting the 'Perceived Barriers Z-scores' from the 'Perceived Benefits Z-scores'. A 'Decision Balance' Z-score of 0 represents the population mean; a positive valence (3) reflects more positive attitudes to clinical trials and negative valence (-3) reflects more negative attitudes.	8 weeks post-randomization
Uncertainty in Cancer Treatment Decision-Making Process	This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).	8 weeks post-randomization
Regret About Cancer Treatment Decision-Making Process	This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret).	8 weeks post-randomization
Satisfaction With Cancer Treatment Decision-Making Process	This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction.	8 weeks post-randomization
Self-confidence in Cancer Treatment Decision-Making Abilities	This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident).	8 weeks post-randomization

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Lamia Barakat, PhD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: AYA
• Other Study ID Numbers: 20-017521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No