RECRUITING

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

Conditions

Solid Tumor Solid Tumor, Adult Solid Tumor, Unspecified, Adult Spanish speaking Latinx 20-539 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-18

Study Completion:2026-06-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04942717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.)

Inclusion Criteria

Exclusion 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.

* 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.)

Contacts and Locations

Study Contact

Judith Nelson, MD

CONTACT

646-888-3107

nelsonj@mskcc.org

Francesca Gany, MD, MS

CONTACT

646-888-8054

ganyf@mskcc.org

Principal Investigator

Judith Nelson, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

SBH Health System

Bronx, New York, 10457

United States

Jacobi Medical Center

Bronx, New York, 10465

United States

MSK at Ralph Lauren (All Protocol Activities)

New York, New York, 10035

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Judith Nelson, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-18

Study Completion Date2026-06-18

Study Record Updates

Study Start Date2021-06-18

Study Completion Date2026-06-18

Terms related to this study

Keywords Provided by Researchers

Spanish speaking
Latinx
Solid Tumor
20-539
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

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