## Protocol Section
### Identification Module
**NCT ID:** NCT06191679

**Acronym:** DECIDES B+

**Brief Title:** Decision Aid for Education and Support About Cancer Treatment

**Official Title:** Decision Aid for Education and Support About Cancer Treatment

#### Organization Study ID Info
**ID:** 20-017521
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Philadelphia
### Status Module
#### Completion Date
**Date:** 2023-04-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-04-13

**Type:** ACTUAL

#### Start Date
**Date:** 2020-07-08

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-01-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-20
**Study First Submit QC Date:** 2023-12-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Philadelphia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 + 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.

**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

### Conditions Module

**Conditions:**

- Cancer

- Childhood Cancer

**Keywords:**

- AYA

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Family Units (AYA and caregiver participants) are randomized to one of three arms: (1) Usual Care \[no intervention\], (2) DECIDES \[access to web-based decision aid\], or (3) DECIDES + Coach \[access to web-based decision aid with coach-assisted support\].

Oncology health care providers of participating AYA are not enrolled in an intervention arm.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 117

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will have access to their oncology health care providers and other members of the health care team for questions related to cancer and cancer treatment (as per usual).

**Label:** Usual Care

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Subjects will receive access to DECIDES with an informational handout that includes goals of the decision support intervention and instructions for accessing the application independently.

**Intervention Names:**

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

**Label:** DECIDES

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Subjects will receive access to DECIDES with live, coach-assisted support.

**Intervention Names:**

- Behavioral: Decision Aid for Education and Support about Cancer Treatment with Coach-Assisted Support (DECIDES + coach)

**Label:** DECIDES + coach

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DECIDES

**Description:** 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.

**Name:** Decision Aid for Education and Support about Cancer Treatment (DECIDES)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- DECIDES + coach

**Description:** 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.

**Name:** Decision Aid for Education and Support about Cancer Treatment with Coach-Assisted Support (DECIDES + coach)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Acceptability of Decision Aid

**Time Frame:** 8 weeks post-enrollment

**Description:** 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").

**Measure:** Systems Usability Scale

**Time Frame:** 8 weeks post-enrollment

**Description:** 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.

**Measure:** Semi-Structured Qualitative Interview

**Time Frame:** 8 weeks post-enrollment

#### Secondary Outcomes

**Description:** 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.

**Measure:** Knowledge of Cancer Clinical Trials

**Time Frame:** 0 weeks post-enrollment and 8 weeks post-enrollment

**Description:** 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 \[range = -3 (negative) - 3 (positive) valence\].

**Measure:** Attitudes toward Cancer Clinical Trials

**Time Frame:** 0 weeks post-enrollment and 8 weeks post-enrollment

**Description:** 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).

**Measure:** Uncertainty in Cancer Treatment Decision-Making Process

**Time Frame:** 8 weeks post-enrollment

**Description:** 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).

**Measure:** Regret about Cancer Treatment Decision-Making Process

**Time Frame:** 8 weeks post-enrollment

**Description:** 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).

**Measure:** Self-confidence in Cancer Treatment Decision-Making Abilities

**Time Frame:** 8 weeks post-enrollment

**Description:** 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.

**Measure:** Satisfaction with Cancer Treatment Decision-Making Process

**Time Frame:** 8 weeks post-enrollment

**Description:** 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.

**Measure:** Perceptions of Physician Engagement in Decision-Making Process

**Time Frame:** 8 weeks post-enrollment

**Description:** 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.

**Measure:** Perceived Involvement in Shared Treatment Decision-Making Process

**Time Frame:** 8 weeks post-enrollment

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 24 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** Children's Hospital of Philadelphia

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital of Philadelphia

**Name:** Lamia Barakat, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-04-12

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-04-12

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
