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Trial Title:
ALIGN for Older Adults With Cancer in SNFs
NCT ID:
NCT06616298
Condition:
Advanced Cancer
Conditions: Keywords:
Skilled Nursing Facility
Caregiver
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Assessing and Listening to Individual Goals and Needs (ALIGN)
Description:
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.3 The intervention is
implemented virtually in community SNFs and follows patients for 45 days after SNF
discharge to reflect real-world patient flow.
Arm group label:
Caregivers of older patients with advanced cancer
Arm group label:
Older patients with advanced cancer
Summary:
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.
Criteria for eligibility:
Criteria:
Patients
Inclusion Criteria:
1. Adults between 18-98 years
2. Stage II-IV solid tumors
3. Discharging from an acute care hospital to a SNF in Colorado
4. English speaking
5. Receiving or establishing care at the University of Colorado Cancer Center
6. If a patient lacks capacity, a legal surrogate decision-maker will be approached to
provide proxy consent.
7. 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 (by participant's assessment).
Exclusion Criteria:
1. Discharging with hospice care
2. Age less than 18
3. Lacking capacity without a legal surrogate decision maker or proxy. Patient with
limited English
Caregivers
Inclusion Criteria:
1. Patient-selected
2. Age ≥ 18
3. English speaking
4. Able to complete baseline measures.
Exclusion Criteria:
1. Discharging with hospice care
2. Age < 18
3. Caregivers with limited English proficiency will be excluded as ALIGN intervention
content and documents have only been validated in an English-speaking population.
SNF Staff
Inclusion Criteria:
1. One of 25 interdisciplinary clinicians from the 5 most common community SNFs
2. Staff must be employed by on of the 5 most common community SNFs named above. (care
managers, social workers, nurses, physical therapists, occupational therapists,
advanced practice providers, and physicians)
Exclusion Criteria:
1. Not employed by one of the top 5 community SNFs patients were discharged to during
the pilot trial
PCSW
Inclusion Criteria:
1. PCSWs who conducted the ALIGN intervention and consent to an interview
Gender:
All
Minimum age:
18 Years
Maximum age:
98 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Colorado Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Contact:
Last name:
Sarguni Singh, MD
Phone:
503-703-0797
Email:
sarguni.singh@ucdenver.edu
Investigator:
Last name:
Sarguni Singh, MD
Email:
Principal Investigator
Start date:
January 2025
Completion date:
March 2028
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06616298
