An Upstream Palliative Care Intervention for Rural Family Caregivers

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



Sponsors


Source

University of Alabama at Birmingham

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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 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.

Overall Status

Not yet recruiting

Start Date

2018-09-01

Completion Date

2021-04-01

Primary Completion Date

2020-10-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Feasibility of retaining 60 family caregiver-patient dyads
From date of enrollment to 24 weeks
Feasibility of intervention completion
From date of enrollment to 24 weeks

Secondary Outcome

Measure

Time Frame

Family Caregiver Quality of Life
Baseline, week 8, and week 24
Family Caregiver Mood (Anxiety/Depressive Symptoms)
Baseline, week 8, and week 24
Patient Quality of Life
Baseline, week 8, and week 24
Patient Mood (Anxiety/Depressive Symptoms)
Baseline, week 8, and week 24

Enrollment

120

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Project Cornerstone basic elements are:
The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician;
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;
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. Project Cornerstone begins within 60 days of a care recipient being diagnosed with advanced cancer and ends 1 year after care recipient death.

Arm Group Label

Project Cornerstone


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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

James N Dionne-Odom, PhD, RN
Principal Investigator
University of Alabama at Birmingham

Overall Contact

Last Name

James N Dionne-Odom, PhD, RN

Phone

(205) 934-7597

Email

dionneod@uab.edu


Location

Facility

Status

Contact

University of Alabama at Birmingham
Birmingham Alabama 35226 United States
Not yet recruiting
Last Name: Marilyn Doss, MA
Phone: 205-934-3789
Email: irb@uab.edu

Location Countries

Country

United States


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Alabama at Birmingham

Investigator Full Name

James N Dionne-Odom

Investigator Title

Assistant Professor


Keywords


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

Usual Care

Arm Group Type

No Intervention

Description

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


Arm Group Label

Project Cornerstone

Arm Group Type

Experimental



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Matthew C Kenny, MPH

Phone

(205) 996-0093

Email

mckenny@uab.edu


Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

Double (Investigator, Outcomes Assessor)


Study First Submitted

March 1, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

June 8, 2018

Last Update Submitted Qc

June 8, 2018

Last Update Posted

June 11, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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