Status:
ACTIVE_NOT_RECRUITING
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Metastatic Cancer
Locally Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 inte...
Eligibility Criteria
Inclusion
- 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
- Willingness to be audio-recorded for assessments and study sessions
- For Caregivers:
- Is a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for a MSK patient
- Fluent in English or Spanish
- Age 18 or older
- Score of \</= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- 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
- Willingness to be audio-recorded for assessments and study sessions
- Psychosocial expert eligibility requirements:
- Current clinical practice and/or research with advanced cancer patients
- A history of 5+ years working with advanced cancer patients. Experts across disciplines (e.g., social work, psychology) may be enrolled.
- Fluent in English as self-reported by a fluency of "Very well"
Exclusion
- 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."
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03794635
Start Date
December 20 2018
End Date
December 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065