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

NCT03794635 | Active Not Recruiting

• 1 other identifier: 18-530
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Locally Advanced Cancer; Thoracic Cancer; Gynecologic Cancer; Genitourinary Cancer; Lymphoma

Keywords

Latina; Latino; Spanish; Caregiver; 18-530; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients

EXPERIMENTAL

Latino/a advanced cancer patients

Behavioral: Weekly 45 minute Sessions

Caregivers

EXPERIMENTAL

Caregivers of Latino/a advanced cancer patients

Behavioral: Weekly 45 minute Sessions

Interventions

Weekly 45 minute Sessions BEHAVIORAL

The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study: 1. A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish) 2. 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. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window. Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention.

Caregivers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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."

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis; Urogenital Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kelly Trevino, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 7, 2019
• Study Start: December 20, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)