An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer

Not Applicable

Active, not recruiting

• Conditions: Locally Advanced Cancer; Thoracic Cancer; Lymphoma; Metastatic Cancer; Gynecologic Cancer; Genitourinary Cancer
• Interventions: Behavioral: Weekly 45 minute Sessions

• Registration Number: NCT03794635
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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
• 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"

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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."

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caregivers	Weekly 45 minute Sessions	Caregivers of Latino/a advanced cancer patients
Patients	Weekly 45 minute Sessions	Latino/a advanced cancer patients

Primary Outcome Measures

Name	Time	Method
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment	3 months
Feasibility of patient-caregiver communication-based intervention defined by participant retention	3 months

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States