Cancer, MetastaticNCT03464188
An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers
A study testing Project Cornerstone in people with Cancer, Metastatic and Family Members, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastatic, Family Members
- What is being tested?
- Project Cornerstone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- 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";
- 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;
- Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below); and
- Caregivers will need NOT need to have an agreeable patient willing to participate in the study (for data collection only).
- English-speaking and able to complete baseline measures.
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- ≥18 years of age;
- 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
- Either: a) resides in a rural zip code or b) is African-American/Black.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35226
About this study
Official title: 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 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.
Read the detailed description
Enrollment goal was increased from 60 to 70 participants due to attrition.
- Conditions
- Cancer, Metastatic, Family Members
- Being tested
- Project Cornerstone
- Keywords
- early palliative care, family caregiver, rural, African-American, telehealth
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project CornerstoneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care family caregiver participants will be informed of the UAB Comprehensive Cancer Center Patient and Family Resources webpage. |
| Project Cornerstone | Experimental | 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. Receives: Behavioral: Project Cornerstone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of retaining 70 family caregiver-patient dyads
Proportion of participants completing study-related assessments from enrollment to 24 weeks
Measured: From date of enrollment to 24 weeks
Feasibility of intervention completion
Proportion of participants completing core coaching sessions from enrollment to 24 weeks
Measured: From date of enrollment to 24 weeks
Secondary outcomes (4)
Family Caregiver Quality of Life
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.
Measured: Baseline, week 8, and week 24
Family Caregiver Mood (Anxiety/Depressive Symptoms)
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.
Measured: Baseline, week 8, and week 24
Patient Quality of Life
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.
Measured: Baseline, week 8, and week 24
Patient Mood (Anxiety/Depressive Symptoms)
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.
Measured: Baseline, week 8, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start20 Oct 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, MetastaticStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, James N Dionne-Odom, University of Alabama at Birmingham
- Investigators
- James N Dionne-Odom, PhD, RN, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464188
- Sponsor's protocol ID
- K99NR015903
- Status last verified
- May 2021
- First submitted
- 1 Mar 2018
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34874061
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Upstream Palliative Care Intervention for Rural Family Caregivers
- ClinicalTrials.gov ID
- NCT03464188
- Acronym / sponsor ID
- K99NR015903
- Conditions
- Cancer, Metastatic, Family Members
- Keywords
- early palliative care, family caregiver, rural, African-American, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care family caregiver participants will be informed of the UAB Comprehensive Cancer Center Patient and Family Resources webpage. |
| Project Cornerstone | Experimental | Behavioral: Project CornerstoneThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years of age;
- 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";
- 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;
- Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below); and
- Caregivers will need NOT need to have an agreeable patient willing to participate in the study (for data collection only).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project CornerstoneProject 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. | Behavioural | Project Cornerstone |
Primary outcome
Feasibility of retaining 70 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
4 secondary outcomes
Family Caregiver Quality of Life
Time frame: Baseline, week 8, and week 24
Family Caregiver Mood (Anxiety/Depressive Symptoms)
Time frame: Baseline, week 8, and week 24
Patient Quality of Life
Time frame: Baseline, week 8, and week 24
Patient Mood (Anxiety/Depressive Symptoms)
Time frame: Baseline, week 8, and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 34874061Dionne-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N Dionne-Odom, PhD, RN principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Cornerstone in people with Cancer, Metastatic and Family Members, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of retaining 70 family caregiver-patient dyads (time frame: From date of enrollment to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.