Clinical trial NCT06305741: A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Patients
Care Givers
Keywords: Anxiety Intervention
Latino caregivers
24-060
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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 ; 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 ≥ 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

Primary outcomes:
measure: percentage of participants to complete all study procedures
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kelly McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: