Solid TumorNCT04942717
Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
A study testing CONVO intervention in people with Solid Tumor and Solid Tumor, Adult, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult, Solid Tumor, Unspecified, Adult
- What is being tested?
- CONVO intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jun 2021to 18 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
MSK at Ralph Lauren (All Protocol Activities)
New York, New York, 10035
Judith Nelson, MD, 646-888-3107
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Judith Nelson, MD, 646-888-3107
- Recruiting
SBH Health System
The Bronx, New York, 10457
Ilmana Fulger, MD, 718-960-3730
- Recruiting
Jacobi Medical Center
The Bronx, New York, 10465
Tarek Elrafei, D.O., 718-918-5686
- Recruiting
New York Cancer & Blood Specialists (Data collection only)
The Bronx, New York, 10469
Richard Zuniga, MD, 631-751-3000
About this study
Official title: Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol
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.
- Being tested
- CONVO intervention
- Keywords
- Spanish speaking, Latinx, Solid Tumor, 20-539, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVO interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Experimental | 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. Receives: Behavioral: CONVO intervention |
| Aim 2 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start18 Jun 2021
- Primary completion18 Jun 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Nelson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942717
- Sponsor's protocol ID
- 20-539
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol
- ClinicalTrials.gov ID
- NCT04942717
- Acronym / sponsor ID
- 20-539
- Keywords
- Spanish speaking, Latinx, Solid Tumor, 20-539, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | Experimental | Behavioral: CONVO interventionFor 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 | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONVO interventionThe 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. | Behavioural | Aim 1 |
Primary outcome
Translation/transcreation of the CONVO intervention
Time frame: 24 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Solid Tumor
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Nelson, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONVO intervention in people with Solid Tumor and Solid Tumor, Adult, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Nelson, MD (646-888-3107, nelsonj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation/transcreation of the CONVO intervention (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.