ALIGN for Older Adults With Cancer in SNFs

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06616298
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 98 Years
Healthy Volunteers
Not accepted

Interventions

  • Assessing and Listening to Individual Goals and Needs (ALIGN) — OTHER
    Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences. A patient navigator supports the patient/caregiver and social worker dynamic by helping patients access care and resources. The intervention is implemented virtually in community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow.

Study Details

The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are: * Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities? * Can the investigator successfully collect information from participants throughout the study? * How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves? Researchers will compare ALIGN to care as it is usually delivered. Participants will: * Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician. * Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.

Key Dates

Start date
Feb 24, 2025
Status verified
Apr 2026
Primary completion
Aug 24, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Older patients with advanced cancer
    Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).
  • Experimental: Caregivers of older patients with advanced cancer
    Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.
  • No Intervention: Control Arm
    Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials.

Primary Outcome Measure

Intervention fidelity as assessed by fidelity checklist [ Time Frame: 2.5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Sarguni Singh, MD
[email protected]
503.703.0797
Sarguni Singh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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