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Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion moved earlier from Dec 31, 2027 to Jun 30, 2027v18
  2. Minor Completion pushed from Jun 30, 2027 to Dec 31, 2027v17
  3. Minor Eligibility criteria expanded, about 40 words Study description expanded, about 766 wordsv16 Show 1 more changeShow less
    • Study description expanded, about 766 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study description shortened, about 38 wordsv15 See this version in full on ClinicalTrials.gov ↗
  5. Minor Enrollment target: estimated 412 to confirmed 387v14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv13
  2. Notable Start date: Jan 7, 2020 to Jan 7, 2021 Trial status: Recruiting to Active, Not Recruiting · Site details revised · Collaborator revisedv12 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Trial status: Active, Not Recruiting to Recruiting Primary completion date: Jun 30, 2025 to Dec 31, 2025 · Completion date: Dec 31, 2025 to Jun 30, 2027 · Site details revisedv11 Show 3 more changesShow less
    • Primary completion date: Jun 30, 2025 to Dec 31, 2025
    • Completion date: Dec 31, 2025 to Jun 30, 2027
    • Site details revised
  4. Notable Primary completion date: Dec 31, 2024 to Jun 30, 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 30, 2025 to Dec 31, 2025 · Site details revisedv10 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 30, 2025 to Dec 31, 2025
    • Site details revised
  5. Minor Primary completion date changed from estimate of Dec 2024 to Dec 31, 2024 Completion date: Jun 2025 to Jun 30, 2025v9 Show 1 more changeShow less
    • Completion date: Jun 2025 to Jun 30, 2025
  6. Minor Enrollment target: 588 to 412 Study description revisedv8 Show 1 more changeShow less
  7. Minor 3 versions Re-verified since Dec 4, 2021, no change to tracked fieldsv5-v7
  8. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2020 to Jan 7, 2020v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2020 to Jan 7, 2020
  9. Notable Start date: Jul 2020 to Nov 2020v3
  10. Minor Study title expanded, about 11 words Study description expanded, about 3 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multi-Year Funded Merit Award - Years 6-7: For this 2-year merit award funding, we propose to continue enrollment beyond 24-weeks and extend follow-up with participants long-term, through the patient's end of life and for 24 weeks post-patient death to test the effectiveness of Cornerstone on caregiver and patient outcomes compared to usual care. * Hypothesis Primary Aim 1: Compared to usual care, Cornerstone caregiver participants will report lower distress as measured by the Hospital Anxiety and Depression Scale in the 24 weeks prior to death. * Hypotheses Secondary Aim 1: Compared to usual care, Cornerstone participants will report better a) QOL (PROMIS Global Health 10)40,54 and b) lower burden (Montgomery-Borgatta Burden Scale)39 in the 24 weeks prior to death. * Hypotheses Aim 2: Compared to usual care, Cornerstone participants' care recipients will report a) lower distress as measured by the Hospital Anxiety and Depression Scale (HADS), b) better QOL, c) better quality of death and dying, and d) lower healthcare utilization, including EOL healthcare utilization, in the 24 weeks prior to deathAim 3: Test the long-term effects of Cornerstone on caregiver bereavement outcomes. * Hypotheses Aim 3: Compared to usual care, Cornerstone caregiver participants will report a) lower distress (HADS), b) higher QOL, c) lower burden, d) higher resilience, and e) lower grief over 24 weeks post-patient death. * Parent Study - Years 1 - 5: This hybrid type I randomized effectiveness-implementation trial is designed to answer the question "Is ENABLE Cornerstone efficacious in enhancing caregiver and patient outcomes?" The primary aims are to assess the effectiveness of ENABLE Cornerstone over 24 weeks (Primary and Secondary Aim). The investigators will also explore implementation cost and cost effectiveness, including healthcare utilization (Aim 3) and other potential mediator/moderator effects of the intervention on coping, social support, and preparedness (Exploratory Aim). The study will recruit 206 family caregivers over the age of 21 reporting that they are the primary unpaid provider of support to a close family member or friend who has been newly-diagnosed with an advanced stage cancer within the past 60 days. Half of the participants will be randomized to ENABLE Cornerstone (n=103) which consists of 6 brief, weekly in-person/telephone sessions followed by monthly follow-up every 4 weeks as needed by participants. The other half will be assigned to a usual care condition (n=103).
Trial Details
NCT Number NCT04318886
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Cancer Institute (NCI)
Conditions Cancer Metastatic, Family Members
Enrollment 387 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov