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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:

• 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 newly diagnosed with a solid tumor, initiating systemic chemotherapy at SBH or Jacobi, and English and/or Spanish speakers, as will their accompanying family speaking either language (if the patient opts to include a family member in the CONVO discussion).

• Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to receive training/lead values discussions in the pilot trial.

Locations
United States
New York
Jacobi Medical Center
Recruiting
Bronx
SBH Health System
Recruiting
Bronx
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Recruiting
New York
MSK at Ralph Lauren (All Protocol Activities)
Recruiting
New York
Contact Information
Primary
Judith Nelson, MD
nelsonj@mskcc.org
646-888-3107
Backup
Francesca Gany, MD, MS
ganyf@mskcc.org
646-888-8054
Time Frame
Start Date: June 18, 2021
Estimated Completion Date: June 18, 2023
Participants
Target number of participants: 234
Treatments
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.
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov