- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07225309
A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer
Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francesca Gany, MD, MS
- Phone Number: 646-888-8054
- Email: ganyf@mskcc.org
Study Contact Backup
- Name: Devika Jutagir, PhD
- Phone Number: 646-888-8361
- Email: jutagird@mskcc.org
Study Locations
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Mexico City, Mexico
- Not yet recruiting
- Instituto Nacional de Cancerologia (INCan)
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Contact:
- Oscar Galindo Vázquez
- Email: psiunigalindo@gmail.com
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New York
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
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Contact:
- Devika Jutagir, PhD
- Phone Number: 646-888-8361
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Principal Investigator:
- Devika Jutagir, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 and suicide risk assessment.
Inclusion Criteria:
EMR Criteria
- Documentation of Disease
Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)
- Definition of Disease [or Measurable Disease]
Diagnosed with stages III or IV
- Prior Treatment
- Receiving ambulatory care at INCan
Self-Report Criteria
- Age ≥ 18 years
- Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- Providing care (or services) to Mexican cancer patients at INCan
- Has access to internet and an electronic device
- Agrees to be audio-recorded
Exclusion Criteria:
EMR Criteria
Prior Treatment
- Received psychological or psychiatric care at INCan in the last 3 months
- 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
- Diagnosed with a serious psychiatric condition
Self-Report Criteria
- Received psychological or psychiatric care outside of INCan in the last 3 months
- Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale
- Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
Provider Eligibility Criteria:
Inclusion Criteria Self-Report Criteria
- Age ≥ 18 years
- Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- Providing care (or services) to Mexican cancer patients at INCan
- Has access to internet and an electronic device
- Agrees to be audio-recorded
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 |
|---|---|
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Experimental: Experimental Intervention
Meaning-Centered Psychotherapy for Latinos (MCP-L)
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MCP-L is a structured 7-session manualized intervention culturally adapted into Spanish for Latino participants diagnosed with advanced cancer, which utilizes a mixture of didactics, discussion and experiential exercises that focus on particular themes related to meaning and advanced cancer.
It is 60-minute individual sessions delivered every week or intermittently (depending on participant preference) for up to approximately 3 months (in this time period) in the event of medical illness.
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No Intervention: Control Intervention
Cognitive Behavioral Therapy (CBT)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time Frame: 1 month
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To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 1-month post-intervention follow-up.
Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
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1 month
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Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time Frame: 3 months
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To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 3-month post-intervention follow-up.
Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
|
3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Devika Jutagir, 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
- Colorectal cancer
- Breast cancer
- Prostate cancer
- Memorial Sloan Kettering Cancer Center
- Thyroid cancer
- Breast cancer Stage III
- Breast cancer Stage IV
- Prostate cancer Stage III
- Prostate cancer Stage IV
- Colorectal cancer Stage III
- Colorectal cancer Stage IV
- Thyroid cancer Stage III
- Thyroid cancer Stage IV
- 25-240
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Thyroid Diseases
- Skin and Connective Tissue Diseases
- Prostatic Neoplasms
- Colorectal Neoplasms
- Breast Neoplasms
- Thyroid Neoplasms
Other Study ID Numbers
- 25-240
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
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