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Quality of life study for caregivers involving in-person or telephone coaching sessions.

Clinicaltrials.gov identifier:
NCT04318886

Quality of Life
Quality of life study for caregivers involving in-person or telephone coaching sessions

Study Contact Information:

Sally Engler, MPH, (205) 996-7564, [email protected]


Coaching for Family Caregivers of People with Advanced Cancer from Rural and Minority Communities

About the Study

This study provides coaching to urban African Americans and rural white or African American families only in the Southeast with cancer and only at the two study sites listed below. Navigators working with an outpatient team, provide six health coaching sessions either in person or over the phone to help with managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning Monthly follow-up is also provided from diagnosis through early bereavement.

What the Study Involves

Participants will be randomly assigned to usual care or are paired with a navigator coach. Family caregivers receive a series of six, brief 20–60-minute telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advanced care planning. After the core sessions, caregivers receive monthly follow-up from the care team until the patient's death. Caregiver and patient outcomes are collected at the beginning of the study and every 12 weeks until the patient's death.

Study Sites

Alabama

Birmingham
University of Alabama at Birmingham
Contact: Sally Engler, MPH, (205) 996-7564, [email protected]

Mobile
University of South Alabama, Mitchell Cancer Institute
Contact: Sally Engler, MPH, (205) 996-7564, [email protected]

 

This Study is Open To:

FAMILY CAREGIVERS (21 years or older)

  • An unpaid spouse/partner, relative or friend who knows the patient well and who provides regular support due to their cancer. This person does not have to live in the same home.
  • Either: a) caring for a patient residing in a rural zip code or b) is African-American.
  • Caring for a patient with cancer. Caregivers will NOT need to have an agreeable patient willing to participate in the study.
  • English-speaking and able to complete baseline measures as described by the study team.

PATIENTS (data collection only, 21 years or older)

  • Diagnosed within past 60 days of initial pre-screening with an advanced cancer, defined as and/or recurrent/progressive III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal (stomach or intestinal), , bladder or kidney cancer, and hematologic malignancies (i.e. leukemia, multiple myeloma, non-Hodgkins , Hodgkins ).
  • Either: a) a patient residing in a rural zip code or b) is African-American.
  • English-speaking and able to complete baseline measures as described by the study team.

*Contact your doctors or the study coordinators for a complete list of inclusion criteria.

This Study is Not Open To:

FAMILY CAREGIVERS with:

  • Self-reported untreated active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal thoughts, uncorrected hearing loss, or active substance abuse, such as drug or alcohol abuse

PATIENTS:

  • Receiving hospice; or
  • Medical record documentation or self-report of untreated active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse. , such as drug or alcohol abuse.

*Contact your doctors or the study coordinators for a complete list of exclusion criteria.