Adaptation of an Evidence-based Goals of Care Communication Intervention for Adolescent and Young Adult Cancer Patients (AYAC)
| Registry | NCT07855484 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 118 (Estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center (Other) |
| Conditions | Cancer |
| Interventions | Jumpstart GOCC intervention (Other) |
| Dates | start 2026-09-25, primary completion 2028-09-25 (estimated), completion 2028-09-25 (estimated), first posted 2026-10-02, last updated 2026-10-08 |
| Locations | 7 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Cancer All trials of Jumpstart GOCC intervention
The purpose of this study is to adapt a goals of care communication tool, called Jumpstart, for adolescent and young adult cancer patients (also called AYAC). Goals of care conversations are discussions between patients and their doctors about the patient's wishes, values, and priorities for their care. The Jumpstart tool was created for adult patients to help start these conversations during doctor's appointments. This study will adapt the tool so that it works better for adolescent and young adult patients with cancer. We will also look at whether the tool is practical and useful for AYAC and for medical doctors who see or treat AYAC patients.
The goal of this project is to adapt an existing, efficacious goals of care conversations (GOCC) Jumpstart intervention for adolescent and young adult cancer patients (AYAC) using the Cultural Adaptation Process Model (CAPM). This goal will be accomplished in three aims: In Aim 1, we will preliminarily adapt the intervention materials. In Aim 2, we will strengthen the preliminarily adapted materials. In Aim 3, we will pilot test the acceptability, feasibility, fidelity, and preliminary impact of the adapted intervention in a pilot cluster RCT.
Aims 1 and 2 will produce patient and oncologist qualitative data from 24 adolescent and young adult cancer patients (AYAC) and 24 oncologists. Participants will complete individual, semi-structured interviews which will be transcribed into text documents by a professional transcribing service.
In Aim 3, we will pilot test the acceptability, feasibility, fidelity, and preliminary impact of the adapted intervention in a pilot cluster RCT. Participants (10 oncologists and 60 AYACs) will be randomized either to receive a goals of care communication intervention or usual care.
Patients in this aim will complete one survey after their appointment. Constructs that will be measured include: feasibility, fidelity, and acceptability (primary outcomes), and quality of communication during GOCC (secondary outcome) measured via patient self-report of quality communication during the GOCC.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients (Adolescent and young adult cancer patients (AYAC) between ages 15-39) on the Jumpstart Arm | Experimental | Other: Jumpstart GOCC intervention | |
| Patients on the SOC/Control Arm | Active comparator | Other: Jumpstart GOCC intervention | |
| Clinicians on the Jumpstart Arm | Experimental | Other: Jumpstart GOCC intervention | |
| Clinicans on the SOC/Control Arm | Active comparator | Other: Jumpstart GOCC intervention |
Sex: All, ages: 18 Years to 39 Years
Inclusion Criteria: Patient (All Aims) * Between ages 18-39; * Has a diagnosis of Stage III or IV cancer as per clinician note in the EMR; * Attended at least one, but no more than three, appointments with their oncologist as per EMR or self-report; * English as their primary language in the EMR; * Can independently consent to study procedures without a surrogate or legally authorized representative; * MSK treating oncologist answers "no" to the question, "Would you be surprised if this patient died within the next year?" * AIMS 2 \& 3 ONLY: Did not participate in previous aims Clinician (All Aims) * are 18 or older; * are an MSK oncologist who sees AYAC patients * AIMS 2 \& 3 ONLY: Did not participate in previous aims Exclusion Criteria: * Clinician (Aims 1 \& 2): none * Patient (Aim 3 ONLY) * if a GOCC has previously been documented in the EMR
| Facility | City | Country | Status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (All protocol activities) | Basking Ridge, New Jersey | United States | |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown, New Jersey | United States | |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale, New Jersey | United States | |
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) | Commack, New York | United States | |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison, New York | United States | |
| Memorial Sloan Kettering Cancer Center | New York, New York | United States | |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Uniondale, New York | United States |