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
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Metastatic Family Members||Behavioral: Project Cornerstone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
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:
- 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
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: James N Dionne-Odom, PhD, RN||(205) email@example.com|
|Contact: Matthew C Kenny, MPH||(205) firstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35226|
|Contact: Marilyn Doss, MA 205-934-3789 email@example.com|
|Principal Investigator:||James N Dionne-Odom, PhD, RN||University of Alabama at Birmingham|