Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04942717
Status
Recruiting
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Conditions

  • Solid Tumor
  • Solid Tumor, Adult
  • Solid Tumor, Unspecified, Adult

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CONVO intervention — BEHAVIORAL
    The CONVO intervention consists of oncology nurse-led discussions exploring patients' health-related values as part of routine oncology care for all patients, from the beginning of oncologic care. Nurses will use the Nurse's Values Discussion Guide. At these sites, chemotherapy nurses will deliver the CONVO discussion, as patients at these sites do not have primary nurses assigned and because oncology doctors, BPs and PAs do not work one-on-one as a pair with a unique nurse.

Study Details

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.

Key Dates

Start date
Jun 18, 2021
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
234 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Aim 1
    For the survey component, recruitment will focus on patients who have not participated in a semi-structured interview as part of the Aim 1 research. For Aim 1, we will seek to recruit approximately 36 patients and 12 family members for the initial key informant interviews, 20 patients for the followup survey, and 10 for the English/backtranslated-English side-by-side comparison.
  • No Intervention: Aim 2
    Patients who provide consent during Months 9-11 (i.e., first three months of "Control Period" of pilot trial) will be in the "control group," with follow-up for outcomes data collection occurring during Months 12-14. Patients who provide consent during Months 16-18 (after implementation of the intervention at the end of Month 15) will be in the "intervention group" and will be followed for three more months (Months 19-21) for outcomes data collection. We will enroll a total of 130 patients (65 in control period, 65 in intervention period) during the pilot trial across the two trial sites, SBH and Jacobi, to reflect, as much as possible, the relative patient numbers and the demographic composition of the sites. During the intervention period, family who accompany patients to clinic and are included (patient option to include one family member) in the CONVO values discussions will be approached (in person or via video conferencing platform or telephone) for participation at the clinic.

Primary Outcome Measure

Translation/transcreation of the CONVO intervention [ Time Frame: 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Judith Nelson, MD
646-888-3107
MSK at Ralph Lauren (All Protocol Activities)New YorkNew York10035
Judith Nelson, MD
646-888-3107
Jacobi Medical CenterThe BronxNew York10465
Tarek Elrafei, D.O.
718-918-5686
New York Cancer & Blood Specialists (Data collection only)The BronxNew York10469
Richard Zuniga, MD
631-751-3000
SBH Health SystemThe BronxNew York10457
Ilmana Fulger, MD
718-960-3730

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By research site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NYMSK at Ralph Lauren (All Protocol Activities)· New York, NYJacobi Medical Center· The Bronx, NYNew York Cancer & Blood Specialists (Data collection only)· The Bronx, NYSBH Health System· The Bronx, NY

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