ALIGN for Older Adults With Advanced Cancer in Skilled Nursing Facilities
This study is testing a new approach called ALIGN (Assessing and Listening to Individual Goals and Needs) for older adults with advanced cancer who are moving from a hospital to a skilled nursing facility. ALIGN uses palliative care social workers to help with changing care preferences, family stress, and communication. The main goal is to see if ALIGN can be successfully delivered in different skilled nursing facilities and if researchers can collect information from participants. This study also aims to understand how to best prepare caregivers for making medical decisions. Researchers will compare ALIGN to the usual care. You might be able to join if you are between 18 and 98 years old, have advanced cancer, are being discharged from a hospital to a skilled nursing facility in Colorado, and receive care at the University of Colorado Cancer Center. The study is currently recruiting 120 participants.
- Study design
- This study is an interventional study involving 120 participants. It aims to compare the ALIGN intervention to usual care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess intervention fidelity and treatment contamination for 2.5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ALIGN for Older Adults With Cancer in SNFs
At a glance
Conditions
NCT06616298
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Colorado Anschutz Medical Campus
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sarguni Singh, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Intervention fidelity as assessed by fidelity checklist2.5 years
Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if at least one component of ≥ 80% of domains on the fidelity checklist are addressed, ≥ 50% of components of at least 1 intervention domain are delivered in follow up visits, and if a discharge note is entered for enrolled patients.
- Intervention fidelity as assessed by audio-recordings2.5 years
Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.
- Assessment of treatment contamination in community skilled nursing facilities2.5 years
The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%.
- The proportion (% total) of screened patients that are eligible for enrollment in the trial2.5 years
The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria
- The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)
- The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)
- The proportion (% total) of enrolled patients that are randomized2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized
- The proportion (% total) of enrolled caregivers that are randomized2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized