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

Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305741
• Other study ID #: 24-060
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kelly McConnell, PhD
• Phone: 646-888-0026
• Email: mcconnek[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

• 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)

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

• 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)

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

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

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 = 9

• Per research staff judgment and/or self-report, too ill or weak to complete study procedures

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer Patients
• Care Givers

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All protocol activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of participants to complete all study procedures		1 year

External Links

•   Memorial Sloan Kettering Cancer Center