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Clinical Trials/NCT03794635
NCT03794635
Active, Not Recruiting
N/A

A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden

Memorial Sloan Kettering Cancer Center1 site in 1 country45 target enrollmentDecember 20, 2018

Overview

Phase
N/A
Intervention
Weekly 45 minute Sessions
Conditions
Metastatic Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
45
Locations
1
Primary Endpoint
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

Brief Summary

This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this study, and a version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. We will use the culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants. This culturally sensitive intervention has the potential to reduce Latino/a patient and caregiver distress and improve patient and caregiver quality of life, shared understanding of the patient's illness, and patients' and caregivers' ability to discuss, identify, and document patients' treatment preferences. The intervention is designed to minimize burden to patients, caregivers, and healthcare institutions to allow for easy integration into clinical practice.

Registry
clinicaltrials.gov
Start Date
December 20, 2018
End Date
December 1, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For Patients:
  • Self-identifies as Latino/a
  • Diagnosis of poor prognosis advanced cancer defined as: (1) locally advanced or metastatic cancer (i.e., thoracic, gynecological, genitourinary cancer, pancreatic or lymphoma) or (2) disease progression following at least first line treatment
  • Fluent in English or Spanish
  • Age 18 or older
  • Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study
  • Score of \</= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)
  • To assess whether a prognostic discussion occurred, the oncologist must answer "Yes" to the following: "Have you discussed the any of the following with Mr./Mrs./Ms. \[INSERT PATIENT"S NAME\]: If his/her cancer is curable, if his/her cancer is terminal, or his/her life expectancy: Yes/No Note: This question will be included in the email in which study staff request permission to contact the patient.
  • As per self-report, residency in New York or ability to complete sessions in New York to ensure that provision of TAC is covered by the professional licenses of TAC interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3 ONLY
  • Able to communicate over the phone for sessions

Exclusion Criteria

  • For Patients
  • As judged by the consenting professional, treating physician or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
  • Receiving hospice at the time of enrollment
  • Deemed inappropriate for the study by their treating physician
  • As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
  • For Caregivers:
  • As judged by the consenting professional, treating physician or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
  • As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
  • Patient-Caregiver Dyads:
  • Both dyad members respond "b" or "d" on the item in Appendix K, "How would you describe your/the patient"s health status: a) Relatively healthy, b) Relatively healthy and terminally ill, c) Seriously ill but not terminally ill, or d) Seriously and terminally ill" and respond "months" on the item "When you think about your/the patient's life expectancy, do you think in terms of months or years."

Arms & Interventions

Patients

Latino/a advanced cancer patients

Intervention: Weekly 45 minute Sessions

Caregivers

Caregivers of Latino/a advanced cancer patients

Intervention: Weekly 45 minute Sessions

Outcomes

Primary Outcomes

Feasibility of patient-caregiver communication-based intervention defined by participant enrollment

Time Frame: 3 months

Feasibility of patient-caregiver communication-based intervention defined by participant retention

Time Frame: 3 months

Study Sites (1)

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