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

Sponsors

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Source Memorial Sloan Kettering Cancer Center
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.

Overall Status Recruiting
Start Date 2021-06-18
Completion Date 2022-06-18
Primary Completion Date 2022-06-18
Study Type Observational
Primary Outcome
Measure Time Frame
Translation/transcreation of the CONVO intervention 24 months
Enrollment 234
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: CONVO intervention

Description: 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.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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 specifically to participate in interviews comparing the original English version of the Nurse Values Discussion Guide, which will be translated/transcreated for the Spanish-speaking Latinx community, with a back-translated (Spanish-to-English) version of this Guide to identify the likely preferred version for English-speaking Latinx patients. - Spanish-speaking 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 and nurses 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. 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.)

Gender:

All

Minimum Age:

21 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Judith Nelson, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Overall Contact

Last Name: Judith Nelson, MD

Phone: 646-888-3107

Email: [email protected]

Location
Facility: Status: Contact:
MSK at Ralph Lauren (All Protocol Activities) | New York, New York, 10035, United States Recruiting Judith Nelson, MD 646-888-3107
Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York, New York, 10065, United States Recruiting Judith Nelson, MD 646-888-3107
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Aim 1

Description: 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.

Label: Aim 2

Description: 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.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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