A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers

March 4, 2026 updated by: Memorial Sloan Kettering Cancer Center

Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christian Nelson, PhD
  • Phone Number: 646-888-0030

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All protocol activities)
        • Contact:
          • Kelly McConnell, PhD
          • Phone Number: 646-888-0026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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
  • Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) age 40 or older who is willing and able to participate in the study ; if a patient does not have a primary informal caregiver or if the caregiver does not or cannot participate, but meets all other inclusion criteria they will be allowed to enroll in the study
  • 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:

    1. 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)
    2. 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:

    1. 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)
    2. What is your preferred language for healthcare? (must respond English and/or Spanish)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Latino caregivers and the Latino older adults with cancer (OACs)
The 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).
Other: Managing Anxiety from Cancer (MAC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of participants to complete all study procedures
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kelly McConnell, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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