NCT07225088

Brief Summary

The purpose of this study is to improve ways of providing mental health support to Spanish-speaking Latino participants who have cancer and experience depression, insomnia, and fatigue. Investigators will test a special mental health intervention called DESCANSO/REST (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep). The intervention can be delivered through telehealth.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
36mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Apr 2029

First Submitted

Initial submission to the registry

October 15, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 5, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

October 15, 2025

Last Update Submit

January 23, 2026

Conditions

Solid TumorSolid Tumor, Adult

Keywords

Solid TumorSolid Tumor Stage ISolid Tumor Stage IISolid Tumor Stage IIIMemorial Sloan Kettering Cancer Center25-277

Outcome Measures

Primary Outcomes (1)

  • Number of participants who complete at least 5 DESCANSO sessions

    Feasibility of DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep) defined as completing at least 5 out of the planned 8 DESCANSO sessions.

    Up to 1 year

Study Arms (2)

Experimental Intervention: DESCANSO

EXPERIMENTAL

Participants will receive DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)

Behavioral: DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English

Control Intervention: Enhanced Usual Care

NO INTERVENTION

Participants will receive Enhanced Usual Care

Interventions

DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in EnglishBEHAVIORAL

DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)

Experimental Intervention: DESCANSO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mental health provider
  • Treats Latino cancer patients and/or survivors
  • Has at least 3 years of clinical experience providing psychosocial services to cancer patients and/or survivors
  • Able to read Spanish determined by the question: "Can you read in Spanish? Yes/No"
  • Patient Eligibility Criteria:
  • A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener.
  • Documentation of Disease
  • o Pathologically confirmed solid tumor cancer (either most recent or new diagnosis)
  • Definition of Disease \[or Measurable Disease\]
  • o Diagnosed with stages I, II, or III
  • Prior Treatment
  • Currently undergoing systemic therapy (chemotherapy, radiation therapy, and/or immunotherapy) or within the first year following completion of systemic therapy Self-Report Criteria
  • Age ≥ 21 years
  • Lives in mainland U.S. or Puerto Rico
  • Identifies as Latino/a or Hispanic
  • +3 more criteria

You may not qualify if:

  • o In the judgment of the treating physician, protocol investigators, and/or study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or study participation
  • Self-Report Criteria
  • History of comorbidities within the last 12 months associated with fatigue and poor sleep, including hypothyroidism or abnormal thyroid function, sleep apnea, chronic obstructive pulmonary disease, neuromuscular disease, alcohol or drug abuse
  • Pregnant or lactating, women only
  • Presence of suicidal risk determined by any affirmative response on the Columbia-Suicide Severity Rating Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

  • Rosario Costas Muniz, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosario Costas Muniz, PhD

CONTACT

646-888-8062costasmr@mskcc.org

Victoria Blinder, MD

CONTACT

646-888-4808blinderv@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2025

First Posted

November 5, 2025

Study Start

January 23, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

• 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.

Locations

US(7)