Decision Support Training for Family Caregivers of Patients with Advanced Cancer, CASCADE Factorial Study

Status: active

This phase II trial evaluates decision support training for family caregivers of patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Over 70% of patients with cancer involve relatives, friends, and partners in healthcare decisions, including choices about cancer treatments, surgery, transitions and location of care, accessing palliative and hospice care, and many others. Patients making healthcare decisions with unprepared family caregivers may experience inadequate family decision support leading to increased distress and receipt of care/treatments that don't align with their values and preferences. This in turn may increase distress for family caregivers. Hence, there is a critical need to train cancer family caregivers to effectively support patient decision-making. The Care Supporters Coached to be Adept Decision partners (CASCADE) program was developed to help family members provide the best decision support possible to the relatives they care for. Providing additional supportive care services for family members and close friends who support someone with cancer, may improve family and patient outcomes.

Inclusion Criteria

FAMILY CAREGIVERS: >= 21 years of age
FAMILY CAREGIVERS: Self-endorsing or identified by the patient as “a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help”
FAMILY CAREGIVERS: Caring for a patient with advanced-stage cancer (see definition under patient inclusion criteria below)
FAMILY CAREGIVERS: Caregivers will need to have an agreeable patient willing to participate in the study for data collection
FAMILY CAREGIVERS: English-speaking and able to complete baseline measures
PATIENTS: >= 21 years of age
PATIENTS: Diagnosed within 60 days of initial screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma, and hematologic malignancies

Exclusion Criteria

FAMILY CAREGIVERS: Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse
PATIENTS: Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse

Additional locations may be listed on ClinicalTrials.gov for NCT04803604.

State:

United States

Alabama

Birmingham

University of Alabama at Birmingham Cancer Center

Status: Active

Contact: James Nicholas Odom

Phone: 205-934-7597

Email: dionneod@uab.edu

Georgia

Atlanta

Emory University Hospital/Winship Cancer Institute

Status: Active

Contact: Dio Kavalieratos

Email: d.kavalieratos@emory.edu

PRIMARY OBJECTIVES:

I. Identify CASCADE decision support training components (main effects/interactions) that contribute meaningfully to improvement over 24 weeks in the primary outcome, patient-reported decisional conflict, measured by the Decisional Conflict Scale and secondary outcomes.

II. Apply results obtained in Aim 1 to build: (1) an intervention made up of only active components and (2) a second intervention that is optimized for scalability and cost.

EXPLORATORY OBJECTIVE:

I. Explore mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) of the relationship between intervention components and patient and caregiver outcomes.

OUTLINE: Participants are randomized to 1 of 16 conditions.

CONDITION I: Participants complete 1 coaching session on support effectiveness, 1 session on communication training, 1 session on Ottawa Guide training, and receive a single follow-up call on study.

CONDITION II: Participants complete 1 coaching session on decision support effectiveness, 1 session on communication training, 1 session on Ottawa Guide training, and receive monthly follow-up calls until week 24 on study.

CONDITION III: Participants complete 1 coaching session on decision support effectiveness, 1 session on communication training, and receive a single follow-up call on study.

CONDITION IV: Participants complete 1 coaching session on decision support effectiveness, 1 session on communication training, and receive monthly follow-up calls until week 24 on study.

CONDITION V: Participants complete 1 coaching session on decision support effectiveness, 1 session on Ottawa Guide training, and receive a single follow-up call on study.

CONDITION VI: Participants complete 1 coaching session on decision support effectiveness, 1 session on Ottawa Guide training, and receive monthly follow-up calls until week 24 on study.

CONDITION VII: Participants complete 1 coaching session on decision support effectiveness and receive a single follow-up call on study.

CONDITION VIII: Participants complete 1 coaching session on decision support effectiveness and receive monthly follow-up calls until week 24 on study.

CONDITION IX: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on communication training, 1 session on Ottawa Guide training, and receive a single follow-up call on study.

CONDITION X: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on communication training,1 session on Ottawa Guide training, and receive monthly follow-up calls until week 24 on study.

CONDITION XI: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on communication training, and receive a single follow-up call on study.

CONDITION XII: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on communication training, and receive monthly follow-up calls until week 24 on study.

CONDITION XIII: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on Ottawa Guide training, and receive a single follow-up call on study.

CONDITION XIV: Participants complete 3 coaching sessions on decision support effectiveness, 1 session on Ottawa Guide training, and receive monthly follow-up calls until week 24 on study.

CONDITION XV: Participants complete 3 coaching sessions on decision support effectiveness and receive a single follow-up call on study.

CONDITION XVI: Participants complete 3 coaching sessions on decision support effectiveness and receive monthly follow-up calls until week 24 on study.

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Decision Support Training for Family Caregivers of Patients with Advanced Cancer, CASCADE Factorial Study

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