NCT04942717 Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
| NCT ID | NCT04942717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2021-06-18 |
| Primary Completion | 2027-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 234 participants in total. It began in 2021-06-18 with a primary completion date of 2027-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to translate and tailor for Latinx participants a program called Communicating with Oncology Nurses about Values from the Outset (CONVO). In CONVO, routine cancer care for each participant includes a discussion between the nurse and participant about the participant's health-related values.
Eligibility Criteria
Inclusion Criteria: * All participants will be adults (age ≥ 21) providing informed verbal consent. We seek a waiver of signed consent, which will allow use of virtual communication during the COVID-19 pandemic period. * Patients will be eligible as key informants in the translation/transcreation process (Aim 1) if they are receiving medical oncology care for a solid tumor malignancy at RLC, SBH, or Jacobi and speak Spanish as their preferred language. In addition, English-speaking Latinx patients will be eligible to participate in interviews based on the back-translated (Spanish-to-English) version of the Guide * We are focusing on patients with solid tumors rather than hematologic malignancies because 1) patients in the latter group may be receiving initial oncologic treatment in the hospital, whereas our study staff will be based at a distance from the hospital in the ambulatory clinics; 2) the trajectory, patient characteristics, and other aspects of hematologic malignancies tend to be different from solid tumor malignancies such that it would be more difficult to understand the overall impact of the intervention if patients with both types of malignancies w ere included. * Spanish-speaking family/other informal caregivers (collectively referred to as "family") who accompany participating patients to clinic will also be eligible to participate in interviews as part of the Aim 1 translation/transcreation process. These will be individual interviews, conducted separately for patient and family participants. * Clinicians eligible for participation in the transcreation will be oncology physicians, nurses and other key clinical staff (e.g. social workers, advance practice providers, etc.) at RLC and other MSK sites who are Latinx and/or whose practice includes \>20% Latinx patients. * Site leaders at SBH, Jacobi, and RLC with administrative responsibility for medical oncology will be eligible as key informants in transcreation of CONVO. * For the Aim 2 pilot trial, patients will be eligible if they are receiving systemic chemotherapy at SBH or Jacobi for a solid tumor; identify as Latinx; and speak English and/or Spanish. Family and/or informal caregivers who accompany the patient and speak English and/or Spanish will also be eligible (if the patient opts to include the family and/or informal caregiver in the CONVO discussion). * Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to participate in the pilot trial. Exclusion Criteria: * Inability to understand consent procedure in either English or Spanish will be an exclusion. (The consenting professional will be bilingual \[English/Spanish\] and able to explain and obtain consent in either language.)
Contact & Investigator
Judith Nelson, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04942717 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04942717 currently recruiting?
Yes, NCT04942717 is actively recruiting participants. Contact the research team at nelsonj@mskcc.org for enrollment information.
Where is the NCT04942717 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, The Bronx, United States, The Bronx, United States and 1 additional location.
Who is sponsoring the NCT04942717 clinical trial?
NCT04942717 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Judith Nelson, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 234 participants.