- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07225088
DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
- Email: costasmr@mskcc.org
Study Contact Backup
- Name: Victoria Blinder, MD
- Phone Number: 646-888-4808
- Email: blinderv@mskcc.org
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Limited protocol activities)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Limited protocol activities)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Limited protocol activities)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
Principal Investigator:
- Rosario Costas Muniz, PhD
-
Rockville Centre, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Limited protocol activites)
-
Contact:
- Rosario Costas Muniz, PhD
- Phone Number: 646-888-8062
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Intervention: DESCANSO
Participants will receive DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)
|
DESCANSO (Depresión/Depressed Mood, Cansancio/Fatigue, and Sueño/Sleep; Rest in English)
|
|
No Intervention: Control Intervention: Enhanced Usual Care
Participants will receive Enhanced Usual Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who complete at least 5 DESCANSO sessions
Time Frame: Up to 1 year
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rosario Costas Muniz, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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