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

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ClinicalTrials.gov Identifier: NCT03464188
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
James N Dionne-Odom, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Cancer, Metastatic Family Members Behavioral: Project Cornerstone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Upstream Palliative Care Intervention for Rural Family Caregivers
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Usual care family caregiver participants will be informed of the UAB Comprehensive Cancer Center Patient and Family Resources webpage.
Experimental: Project Cornerstone Behavioral: 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.




Primary Outcome Measures :
  1. Feasibility of retaining 60 family caregiver-patient dyads [ Time Frame: From date of enrollment to 24 weeks ]
    Proportion of participants completing study-related assessments from enrollment to 24 weeks

  2. Feasibility of intervention completion [ Time Frame: From date of enrollment to 24 weeks ]
    Proportion of participants completing core coaching sessions from enrollment to 24 weeks


Secondary Outcome Measures :
  1. Family Caregiver Quality of Life [ Time Frame: Baseline, week 8, and week 24 ]
    The Caregiver Quality of Life Index- Cancer (CQOLC) scale is a 35-item cancer-specific instrument that assesses the carer of a cancer patient's quality of life, that is, some of the physical, social, emotional, and financial aspects of well-being, and functioning.

  2. Family Caregiver Mood (Anxiety/Depressive Symptoms) [ Time Frame: Baseline, week 8, and week 24 ]
    This Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, containing 7 items each for symptoms of depression and anxiety over the past 7 days. Subscale scores range from 0-21 with scores ≥8 indicating abnormally high symptoms.

  3. Patient Quality of Life [ Time Frame: Baseline, week 8, and week 24 ]
    The Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) is a 46-item scale, composed of physical, emotional, social, and functional well-being and additional concern subscales. Scores range from 0 to 184, where a higher score represents higher quality of life.

  4. Patient Mood (Anxiety/Depressive Symptoms) [ Time Frame: Baseline, week 8, and week 24 ]
    This Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, containing 7 items each for symptoms of depression and anxiety over the past 7 days. Subscale scores range from 0-21 with scores ≥8 indicating abnormally high symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464188


Contacts
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Contact: James N Dionne-Odom, PhD, RN (205) 934-7597 dionneod@uab.edu
Contact: Matthew C Kenny, MPH (205) 996-0093 mckenny@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35226
Contact: Marilyn Doss, MA    205-934-3789    irb@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: James N Dionne-Odom, PhD, RN University of Alabama at Birmingham

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Responsible Party: James N Dionne-Odom, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03464188     History of Changes
Other Study ID Numbers: K99NR015903 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James N Dionne-Odom, University of Alabama at Birmingham:
early palliative care
family caregiver
rural
African-American
telehealth