Trial Title:
A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
NCT ID:
NCT06305741
Condition:
Cancer Patients
Care Givers
Conditions: Official terms:
Anxiety Disorders
Conditions: Keywords:
Anxiety Intervention
Latino caregivers
24-060
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Managing Anxiety from Cancer (MAC)
Description:
The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy
intervention delivered via videoconference.
and/or telephone by licensed social workers
Arm group label:
Latino caregivers and the Latino older adults with cancer (OACs)
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.
Criteria for eligibility:
Criteria:
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 ≥ 11
- Per research staff judgment and/or self-report, too ill or weak to complete study
procedures
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Bergen (All Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Facility:
Name:
Memorial Sloan Kettering Nassau (All Protocol Activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly McConnell, PhD
Phone:
646-888-0026
Start date:
March 5, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06305741
http://www.mskcc.org/mskcc/html/44.cfm
