Solid TumorNCT07225088
DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer
A study testing DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English in people with Solid Tumor and Solid Tumor, Adult, run by Ponce Medical School Foundation, Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult
- What is being tested?
- DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Oct 2025to 31 Jul 2030
- Phase
- Interventional
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Age ≥ 21 years
- Lives in mainland U.S. or Puerto Rico
- Identifies as Latino/a or Hispanic
- Reports Spanish as their preferred language
- Speaks Spanish "Very well" or "Well" as determined by the question: "How well do you speak Spanish?"
- Presence of fatigue and disturbed sleep determined by a score of ≥ 3 on the MD Anderson Symptom Inventory
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Eida Castro, PsyD contact
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Devika Jutagir, PhD, 646-888-8361
Devika Jutagir, PhD
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Devika Jutagir, PhD, 646-888-8361
Puerto Rico1 site, 1 recruiting
- Recruiting
Ponce Medical Schol Foumdation
Ponce, PR, 00716-2347
Jean J Torres, 7878402575, jtorres@psm.edu
Kenira Thompson
About this study
Official title: DESCANSO/REST (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep): A Trial Assessing Feasibility and Acceptability of an Intervention for Depressed Mood, Insomnia, and Fatigue Symptoms in Latino Cancer Patients
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.
- Conditions
- Solid Tumor, Solid Tumor, Adult
- Being tested
- DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English
- Keywords
- Solid Tumor, Solid Tumor Stage I, Solid Tumor Stage II, Solid Tumor Stage III, 25-277
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in EnglishBehavioural
DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention: DESCANSO | Experimental | Participants will receive DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Oct 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosario Costas-Muniz, PhD, Principal investigator, Ponce Medical School Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225088
- Sponsor's protocol ID
- 25-277
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • PHSU 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.