DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer
Recruiting · NCT07225088 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
DESCANSO/Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English
What this trial is 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.
Who can take part
Age range
21 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Pathologically confirmed solid tumor cancer (either most recent or new diagnosis)
- Definition of Disease \[or Measurable Disease\]
- 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
- 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
Where it is running
7 locations listed across 2 US states.
- Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) - Commack, New York, United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) - Rockville Centre, New York, United States