Decision Aid for Education and Support About Cancer Treatment

Cancer Clinical Trial

— DECIDES B+  

Official title:

Decision Aid for Education and Support About Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06191679
• Other study ID #: 20-017521
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: April 13, 2023

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 + Coach. 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 + Coach' groups will receive access to DECIDES, and those in 'DECIDES + Coach' 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 + Coach' groups will complete a semi-structured qualitative interview. Oncology health care providers of participating AYA will be invited to participate in a questionnaire and semi-structured qualitative interview. Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES (with and without coach-assisted support) report more positive decision-making processes compared to those that receive usual standard of care.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Adolescent and Young Adults (AYA)

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)

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

INCLUSION CRITERIA:

• Parent or Legal Guardian of a participating AYA

• Ability to read and speak English

EXCLUSION CRITERIA:

• Foster parent or child advocate (i.e., caregiver is not biological parent or legal guardian)

• Inability to read or speak English

Oncology Health Care Providers

INCLUSION CRITERIA:

• Oncology health care provider involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)

• Ability to read and speak English

EXCLUSION CRITERIA:

• Oncology health care provider that is not involved in decision-making about cancer treatment with enrolled AYA patients and caregiver(s)

• Inability to read or speak English

Related Conditions & MeSH terms

• Cancer
• Childhood Cancer

Intervention

Behavioral:
• Decision Aid for Education and Support about Cancer Treatment (DECIDES)
DECIDES is a developmentally appropriate, engaging and interactive web-based decision support application designed to address health literacy through education about cancer and cancer treatment, and provide support for AYA patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.
• Decision Aid for Education and Support about Cancer Treatment with Coach-Assisted Support (DECIDES + coach)
Live support in the form of a coach is provided to support navigation of DECIDES and promote involvement in decision-making. DECIDES is a developmentally appropriate, engaging and interactive web-based decision support application designed to address health literacy through education about cancer and cancer treatment, and provide support for AYA patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 + Coach). 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.	8 weeks post-enrollment
Primary	Systems Usability Scale	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-enrollment
Primary	Semi-Structured Qualitative Interview	A semi-structured qualitative interview is conducted with AYA, caregivers, and oncology health care providers to assess the acceptability, feasibility, and usability of DECIDES. Interview data is used to inform implementation strategies for future dissemination.	8 weeks post-enrollment
Secondary	Knowledge of Cancer Clinical Trials	This is a 25-item true/false questionnaire collected to measure AYA and caregiver knowledge of clinical trials. Items are scored (correct versus incorrect) and an overall knowledge score that ranges from 0-100 is calculated based on % correct.	0 weeks post-enrollment and 8 weeks post-enrollment
Secondary	Attitudes toward Cancer Clinical Trials	This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Higher scores reflect more support for participation (range = 6-30), perceived incentives for participation (range = 3-15), trust in participation (range = 11-55), barriers/costs to participation (range = 9-45) and greater decision balance about participation [range = -3 (negative) - 3 (positive) valence].	0 weeks post-enrollment and 8 weeks post-enrollment
Secondary	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-enrollment
Secondary	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-enrollment
Secondary	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-enrollment
Secondary	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-enrollment
Secondary	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-enrollment
Secondary	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-enrollment