Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04942717

Conditions

Solid Tumor

Solid Tumor, Adult

Solid Tumor, Unspecified, Adult

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

CONVO intervention

Study Details

Brief 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.

Conditions

Solid Tumor

Solid Tumor, Adult

Solid Tumor, Unspecified, Adult

Study ID

NCT04942717

Start date

Jun 18, 2021

Status verified date

Jul, 2026

Completion date

Jun 18, 2027

Anticipated

Primary completion date

Jun 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

234 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Judith Nelson, MD

646-888-3107nelsonj@mskcc.org

Francesca Gany, MD, MS

646-888-8054ganyf@mskcc.org

Locations

MSK at Ralph Lauren (All Protocol Activities)

Recruiting

New York, New York, United States, 10035

Contacts

Judith Nelson, MD

646-888-3107

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Judith Nelson, MD

646-888-3107

SBH Health System

Recruiting

The Bronx, New York, United States, 10457

Contacts

Ilmana Fulger, MD

718-960-3730

Jacobi Medical Center

Recruiting

The Bronx, New York, United States, 10465

Contacts

Tarek Elrafei, D.O.

718-918-5686

New York Cancer & Blood Specialists (Data collection only)

Recruiting

The Bronx, New York, United States, 10469

Contacts

Richard Zuniga, MD

631-751-3000

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-02.