A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers
1 other identifier
interventional
60
1 country
7
Brief Summary
The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedStudy Start
First participant enrolled
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 6, 2026
March 1, 2026
3 years
March 5, 2024
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of participants to complete all study procedures
1 year
Study Arms (1)
Latino caregivers and the Latino older adults with cancer (OACs)
EXPERIMENTALThe intervention, MAC, is a seven-session (45- 60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers. All sessions will be audio-recorded. MAC content, structure, and length are consistent with core components of cognitive behavioral therapy (CBT) (Freeman, 2004).
Interventions
The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers OR at least a Master's level (or enrolled in a doctorate program) advanced trainees in mental health fields.
Eligibility Criteria
You may qualify if:
- Older Adults with Cancer (OAC)
- As per medical record or self-report, is currently age 65 years or older
- As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.
- As per self-report, identifies as Latino and/or Hispanic Ethnicity
- Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
- Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:
- How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- What is your preferred language for healthcare? (must respond English and/or Spanish)
- Caregiver
- Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for the eligible OAC patient
- As per self-report, is age 40 years or older
- Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:
- How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- What is your preferred language for healthcare? (must respond English and/or Spanish)
You may not qualify if:
- OAC
- As per medical record or self-report, currently receiving psychotherapy
- As per medical record or self-report, taking psychotropic medications for \< 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
- As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
- Per research staff judgment and/or self-report, too ill or weak to complete study procedures
- Per medical record or self-report, receiving hospice care at the time of enrollment
- Caregiver
- As per self-report, currently receiving psychotherapy
- As per self-report, taking psychotropic medications for \< 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
- As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
- Per research staff judgment and/or self-report, too ill or weak to complete study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly McConnell, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
March 5, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.