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Recruiting NCT07225088

DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer

No phase Interventional Solid Tumor Solid Tumor, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English.
Who it may be relevant to
Registry conditions: Solid Tumor, Solid Tumor, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of participants who complete at least 5 DESCANSO sessions [Time frame: Up to 1 year]

Eligibility criteria

Provider Eligibility Criteria:

Participant eligibility will be determined by a self-report screener. Inclusion Criteria Self-Report Criteria

  • 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.

Inclusion Criteria EMR Criteria

  • 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
  • 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

Exclusion Criteria EMR Criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre

Identifiers

NCT: NCT07225088 · 25-277

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗