An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2018 |
| Start Date: | October 20, 2018 |
| End Date: | April 2021 |
| Contact: | James N Dionne-Odom, PhD, RN |
| Email: | dionneod@uab.edu |
| Phone: | (205) 934-7597 |
An Upstream Palliative Care Intervention for Rural Family Caregivers
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 60 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 60 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.
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 60 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 60 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.
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.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-934-3789
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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