ALIGN for Older Adults With Cancer in SNFs
Recruiting now · Not applicable
Conditions studied: Advanced Cancer
In brief
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 facts
- Study ID
- NCT06616298
- Run by
- University of Colorado, Denver
- People needed
- 120
- Starts
- 2025-02-24
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older, up to 98. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults between 18-98 years
- Stage I-IV solid tumors
- Discharging from an acute care hospital to a SNF in Colorado
- English speaking
- Receiving or establishing care at the University of Colorado Cancer Center
- If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.
- Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits.
- Must have an email address or caregiver with an email address to facilitate communication during the trial
You may not qualify if…
- Discharging with hospice care
- Age less than 18
- Lacking capacity without a legal surrogate decision maker or proxy.
- Limited English proficiency
- Hospitalized for a planned admission or procedure
- Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study
- Caregivers
- Inclusion Criteria:
- Patient-selected
- Age ≥ 18
- English speaking
- Able to complete baseline measures.
- Exclusion Criteria:
- Discharging with hospice care
- Age ≤ 18
- Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.
- Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study
- SNF Staff
- Inclusion Criteria:
- Working at a SNF that cared for a patient who received the ALIGN intervention
- Exclusion Criteria:
- Not employed by a community SNF where patients were discharged to during the pilot trial
- PCSW
- Inclusion Criteria:
- PCSWs who conducted the ALIGN intervention and consent to an interview
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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