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

NCT ID: NCT06305741

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Patients Care Givers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Managing Anxiety from Cancer (MAC)

Intervention Type OTHER

The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy intervention delivered via videoconference.

and/or telephone by licensed social workers

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
* 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 ≥ 9
* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelly McConnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelly McConnell, PhD

Role: CONTACT

646-888-0026

Christian Nelson, PhD

Role: CONTACT

646-888-0030

Facility Contacts

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Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Kelly McConnell, PhD

Role: primary

646-888-0026

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-060

Identifier Type: -

Identifier Source: org_study_id

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