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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Solid Tumor
Solid Tumor, Adult

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

125 participants in 2 patient groups

Experimental Intervention: DESCANSO
Experimental group
Description:
Participants will receive DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)
Treatment:
Behavioral: DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English
Control Intervention: Enhanced Usual Care
No Intervention group
Description:
Participants will receive Enhanced Usual Care

Trial contacts and locations

7

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Central trial contact

Victoria Blinder, MD; Rosario Costas Muniz, PhD

Data sourced from clinicaltrials.gov

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