Clinical trial NCT03464188: An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers
Official title: An Upstream Palliative Care Intervention for Rural Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Metastatic
Family Members
Keywords: early palliative care
family caregiver
rural
African-American
telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-03-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The burden placed on advanced cancer family caregivers (FCGs) and the toll on their mental and physical health have never been greater and is particularly pernicious for underserved groups in the Southeastern U.S., including rural-dwellers and African-Americans, for whom interventions have not been specifically developed and tested. The purpose of this K99/R00 is provide the awardee with the knowledge and training necessary to become a leading independent clinical investigator in developing and testing telehealth palliative care interventions for family caregivers (FCGs) of underserved persons with advanced cancer. The research specific aim during the K99 phase was to develop and tailor the content, format and delivery of a telehealth intervention for FCGs of persons with advanced cancer in the rural South. To meet this aim, qualitative semi-structured interviews were conducted with 26 lay healthcare navigators, 20 FCGs, and 18 patients with advanced cancer to elicit feedback on a FCG intervention outline based on published evidence-based interventions. After thematic analysis, major findings included that the intervention should: have topical content that is flexible and based on continuous assessment; include at least some face-to-face contact; cautiously consider internet-based technologies because internet access in rural areas is poor; and potentially have navigators lead the intervention with appropriate oversight and additional training. K99 study findings have been used to adapt and develop a potentially scalable FCG intervention in the Southern U.S. population (Project Cornerstone). The K99 study phase in combination with accomplishing the training objectives has successfully catalyzed the awardee's transition from a Postdoctoral Fellow to a Tenure-Track Assistant Professor at the University of Alabama at Birmingham School of Nursing. The overall goal during the R00 phase will be to conduct a small-scale pilot RCT of Cornerstone with 70 FCGs of rural-dwelling and/or African-American patients with advanced cancer to assess acceptability, feasibility, and potential efficacy. The research specific aims during the R00 phase are to: evaluate the acceptability of Cornerstone and the feasibility of enrolling and retaining 70 participants into a RCT of the FCG intervention for 24 weeks (Aim 1) and evaluate the potential efficacy of Cornerstone in improving caregiver (Aim 2) and care recipient (Aim 3) outcomes compared to usual care (quality of life and distress \[anxiety/depressive symptoms\]). The results will directly support an R-01 application to conduct an efficacy RCT of an early, telehealth PC intervention for Southern FCGs of underserved persons with advanced cancer.

Detailed description: Enrollment goal was increased from 60 to 70 participants due to attrition.

Eligibility criteria: FAMILY CAREGIVERS

Inclusion Criteria:

1. ≥18 years of age;
2. 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 care and who may or may not live in the same residence as you and who is not paid for their help";
3. Either caring for a patient: a) residing in a rural zip code (as classified by the U.S. Census' Rural-Urban Commuting Area \[RUCA\] system as small rural, large rural, and isolated \[hereafter referred to as "rural"\]) or b) who is African-American/Black;
4. Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below); and
5. Caregivers will need NOT need to have an agreeable patient willing to participate in the study (for data collection only).
6. English-speaking and able to complete baseline measures.

Exclusion Criteria:

1) Self-reported severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse

PATIENTS

Inclusion Criteria:

1. ≥18 years of age;
2. Diagnosed within past 60 days of initial screening with an advanced cancer, defined as metastatic stage III/IV solid-tumor cancers of the lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and melanoma; and
3. Either: a) resides in a rural zip code or b) is African-American/Black.

Exclusion Criteria:

1) 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.

Primary outcomes:
measure: Feasibility of retaining 70 family caregiver-patient dyads
timeFrame: From date of enrollment to 24 weeks
measure: Feasibility of intervention completion
timeFrame: From date of enrollment to 24 weeks
Secondary outcomes:
measure: Family Caregiver Quality of Life
timeFrame: Baseline, week 8, and week 24
measure: Family Caregiver Mood (Anxiety/Depressive Symptoms)
timeFrame: Baseline, week 8, and week 24
measure: Patient Quality of Life
timeFrame: Baseline, week 8, and week 24
measure: Patient Mood (Anxiety/Depressive Symptoms)
timeFrame: Baseline, week 8, and week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James N Dionne-Odom, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dionne-Odom JN, Azuero A, Taylor RA, Dosse C, Bechthold AC, Currie E, Reed RD, Harrell ER, Engler S, Ejem DB, Ivankova NV, Martin MY, Rocque GB, Williams GR, Bakitas MA. A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial. Cancer. 2022 Mar 15;128(6):1321-1330. doi: 10.1002/cncr.34044. Epub 2021 Dec 7.