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

Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Solid Tumor, Adult; Solid Tumor, Unspecified, Adult
• Intervention / Treatment: Behavioral: CONVO intervention

• Study Type: Observational
• Enrollment (Estimated): 234

Contacts and Locations

• Study Contact: Name: Judith Nelson, MD; Phone Number: 646-888-3107; Email: nelsonj@mskcc.org
• Study Contact Backup: Name: Francesca Gany, MD, MS; Phone Number: 646-888-8054; Email: ganyf@mskcc.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10457
      • Recruiting
      • SBH Health System
      • Contact: Ilmana Fulger, MD; Phone Number: 718-960-3730
    • Bronx, New York, United States, 10465
      • Recruiting
      • Jacobi Medical Center
      • Contact: Tarek Elrafei, D.O.; Phone Number: 718-918-5686
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Judith Nelson, MD; Phone Number: 646-888-3107
    • New York, New York, United States, 10035
      • Recruiting
      • MSK at Ralph Lauren (All Protocol Activities)
      • Contact: Judith Nelson, MD; Phone Number: 646-888-3107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Aim 1 will involve recruitment of patients, family/other informal caregivers or surrogates of patients (collectively "family"), clinicians (physicians and nurses), and site leaders as key informants (participating in semi-structured, audio-recorded, interviews or a patient/family survey) for translation and transcreation (linguistic and cultural adaptation) of the CONVO intervention for Spanish-speaking Latinx patients. Aim 2 will involve recruitment of patients, family, and nurses into a pre-post pilot trial to evaluate the feasibility and effectiveness of the intervention as implemented in English and Spanish at two oncology clinics where Latinx patients are strongly represented in the patient population.

Description

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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: CONVO intervention; 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.
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.	Behavioral: CONVO intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Translation/transcreation of the CONVO intervention	To translate/transcreate (linguistic plus cultural adaptation) our intervention for implementation with Spanish-speaking Latinx cancer patients receiving outpatient oncologic care in their communities: Comunicar Nuestros Valores a las enfermeras de Oncología desde el comienzo del tratamiento de cáncer.	24 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Judith Nelson, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Solid Tumor; Spanish speaking; Latinx; 20-539
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 20-539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No