An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
- Conditions
- Metastatic CancerGenitourinary CancerLocally Advanced CancerThoracic CancerGynecologic CancerLymphoma
- Registration Number
- NCT03794635
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria:<br><br>For Patients:<br><br> - Self-identifies as Latino/a<br><br> - Diagnosis of poor prognosis advanced cancer defined as: (1) locally advanced or<br> metastatic cancer (i.e., thoracic, gynecological, genitourinary cancer, pancreatic<br> or lymphoma) or (2) disease progression following at least first line treatment<br><br> - Fluent in English or Spanish<br><br> - Age 18 or older<br><br> - Has a primary informal caregiver (as defined by an unpaid individual who provides<br> the patient with emotional, physical, and/or practical support) who is willing and<br> able to participate in the study<br><br> - Score of </= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)<br><br> - To assess whether a prognostic discussion occurred, the oncologist must answer Yes<br> to the following: Have you discussed the any of the following with Mr./Mrs./Ms.<br> [INSERT PATIENTS NAME]: If his/her cancer is curable, if his/her cancer is<br> terminal, or his/her life expectancy: Yes/No Note: This question will be included in<br> the email in which study staff request permission to contact the patient.<br><br> - As per self-report, residency in New York or ability to complete sessions in New<br> York to ensure that provision of TAC is covered by the professional licenses of TAC<br> interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3<br> ONLY<br><br> - Able to communicate over the phone for sessions<br><br> - Willingness to be audio-recorded for assessments and study sessions<br><br>For Caregivers:<br><br> - Is a primary informal caregiver (as defined by an unpaid individual who provides the<br> patient with emotional, physical, and/or practical support) for a MSK patient<br><br> - Fluent in English or Spanish<br><br> - Age 18 or older<br><br> - Score of </= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)<br><br> - As per self-report, residency in New York or ability to complete sessions in New<br> York to ensure that provision of TAC is covered by the professional licenses of TAC<br> interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3<br> ONLY<br><br> - Able to communicate over the phone for sessions<br><br> - Willingness to be audio-recorded for assessments and study sessions<br><br>Psychosocial expert eligibility requirements:<br><br> - Current clinical practice and/or research with advanced cancer patients<br><br> - A history of 5+ years working with advanced cancer patients. Experts across<br> disciplines (e.g., social work, psychology) may be enrolled.<br><br> - Fluent in English as self-reported by a fluency of Very well<br><br>Exclusion Criteria:<br><br>For Patients<br><br> - As judged by the consenting professional, treating physician or self-report, too<br> weak or cognitively impaired to participate in the intervention and complete the<br> assessments<br><br> - Receiving hospice at the time of enrollment<br><br> - Deemed inappropriate for the study by their treating physician<br><br> - As per medical record or self-report, currently being treated for schizophrenia,<br> substance use or dependence, and/or bi-polar disorder<br><br>For Caregivers:<br><br> - As judged by the consenting professional, treating physician or self-report, too<br> weak or cognitively impaired to participate in the intervention and complete the<br> assessments<br><br> - As per self-report, currently being treated for schizophrenia, substance use or<br> dependence, and/or bi-polar disorder<br><br>Patient-Caregiver Dyads:<br><br> - Both dyad members respond b or d on the item in Appendix K, How would you<br> describe your/the patients health status: a) Relatively healthy, b) Relatively<br> healthy and terminally ill, c) Seriously ill but not terminally ill, or d) Seriously<br> and terminally ill and respond months on the item When you think about your/the<br> patient's life expectancy, do you think in terms of months or years.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of patient-caregiver communication-based intervention defined by participant enrollment;Feasibility of patient-caregiver communication-based intervention defined by participant retention
- Secondary Outcome Measures
Name Time Method