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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Cancer Patients; Care Givers

Treatments: Other: Managing Anxiety from Cancer (MAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06305741

24-060

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Latino caregivers and the Latino older adults with cancer (OACs)

Experimental group

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. All sessions will be audio-recorded. MAC content, structure, and length are consistent with core components of cognitive behavioral therapy (CBT) (Freeman, 2004).

Treatment:

Other: Managing Anxiety from Cancer (MAC)