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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942717
• Other study ID #: 20-539
• Status: Recruiting
• Start date: June 18, 2021
• Est. completion date: June 18, 2026

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Judith Nelson, MD
• Phone: 646-888-3107
• Email: nelsonj[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: June 18, 2026
• Est. primary completion date: June 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	SBH Health System	Bronx	New York
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	MSK at Ralph Lauren (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center