RECRUITING

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

Conditions

Cancer Patients Care Givers Anxiety Intervention Latino caregivers 24-060

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-05

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06305741

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * Scores ≥8 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) * 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 * As per self-report, identifies as Latino and/or Hispanic Ethnicity * 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)	* 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 * Does not have a caregiver who meets study eligibility criteria and is willing to participate in the study. * 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

Inclusion Criteria

Exclusion Criteria

* 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
* Scores ≥8 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)
* 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
* As per self-report, identifies as Latino and/or Hispanic Ethnicity
* 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)

* 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
* Does not have a caregiver who meets study eligibility criteria and is willing to participate in the study.
* 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

Contacts and Locations

Study Contact

Kelly McConnell, PhD

CONTACT

646-888-0026

mcconnek@mskcc.org

Christian Nelson, PhD

CONTACT

646-888-0030

Principal Investigator

Kelly McConnell, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Kelly McConnell, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2024-03-05

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-03-05

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Anxiety Intervention
Latino caregivers
24-060

Additional Relevant MeSH Terms

Cancer Patients
Care Givers