A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
Recruiting · NCT06305741 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Managing Anxiety from Cancer (MAC)
What this trial is 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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- lder 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:
- 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)
- 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:
- 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)
- What is your preferred language for healthcare? (must respond English and/or Spanish)
Exclusion criteria
- 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 ≥ 11
- 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
Where it is running
7 locations listed across 2 US states.
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) - Basking Ridge, New Jersey, 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 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 Cancer Center (All protocol activities) - New York, New York, United States
- Memorial Sloan Kettering Nassau (All Protocol Activities) - Rockville Centre, New York, United States