An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers

NCT ID: NCT03464188

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2021-03-30

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.

Conditions

Cancer, Metastatic; Family Members

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

Usual care family caregiver participants will be informed of the UAB Comprehensive Cancer Center Patient and Family Resources webpage.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Project Cornerstone

The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician. Regular caregiver distress thermometer screening and problem support and self-care coaching. Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions.

Group Type: EXPERIMENTAL

Project Cornerstone

Intervention Type: BEHAVIORAL

Project Cornerstone basic elements are:

1. The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician;

2. 6 base telephone/in-person sessions: Sessions cover specific topics (every 1-2 weeks, 20-60 minutes/session; by phone or in-person), followed by monthly follow-up and additional coaching sessions as needed;

3. Regular caregiver distress thermometer screening and problem support and self-care coaching.

4. Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions. Project Cornerstone begins within 60 days of a care recipient being diagnosed with advanced cancer and ends 1 year after care recipient death.

Interventions

Project Cornerstone

Project Cornerstone basic elements are:

1. The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician;

2. 6 base telephone/in-person sessions: Sessions cover specific topics (every 1-2 weeks, 20-60 minutes/session; by phone or in-person), followed by monthly follow-up and additional coaching sessions as needed;

3. Regular caregiver distress thermometer screening and problem support and self-care coaching.

4. Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions. Project Cornerstone begins within 60 days of a care recipient being diagnosed with advanced cancer and ends 1 year after care recipient death.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

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.

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) 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

James N Dionne-Odom

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James N Dionne-Odom, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34874061 (View on PubMed)

Other Identifiers

K99NR015903

Identifier Type: NIH

Identifier Source: org_study_id

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