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CancerDECIDES B+NCT06191679

Decision Aid for Education and Support About Cancer Treatment

A study testing Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention) in people with Cancer and Childhood Cancer, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Cancer, Childhood Cancer
What is being tested?
Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteUnited States
Study dates
8 Jul 2020to 13 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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)
  1. 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
  1. 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
  1. 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 locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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:

Read more
  • 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.

Read the 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
Being tested
Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
Keywords
AYA
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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
Study groups in NCT06191679
Study groupRoleWhat they receive
Usual CareNo interventionSubjects 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)ExperimentalSubjects 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.
Receives: Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)
DECIDES with Coach-Assisted Support (DECIDES+)ExperimentalSubjects will receive access to the decision support intervention (DECIDES) along with live coach-assisted support for accessing and navigating the web-based application.
Receives: Behavioral: Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks post-randomization

  2. 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").

    Measured: 8 weeks post-randomization

Secondary outcomes (8)

  1. 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.

    Measured: 8 weeks post-randomization

  2. 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.

    Measured: 8 weeks post-randomization

  3. 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.

    Measured: 8-weeks post randomization

  4. 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.

    Measured: 8 weeks post-randomization

  5. 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).

    Measured: 8 weeks post-randomization

  6. 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).

    Measured: 8 weeks post-randomization

  7. 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.

    Measured: 8 weeks post-randomization

  8. 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).

    Measured: 8 weeks post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start8 Jul 2020
  3. Primary completion13 Apr 2023
  4. Study completion13 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06191679
Sponsor's protocol ID
20-017521
Acronym
DECIDES B+
Status last verified
Nov 2024
First submitted
20 Dec 2023
Last updated
6 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40584145

Questions about this trial

What is this clinical trial studying?

A study testing Decision Aid for Education and Support about Cancer Treatment (DECIDES Intervention) in people with Cancer and Childhood Cancer, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Decision Aid (time frame: 8 weeks post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06191679, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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