Palliative care intervention for older adults with advanced cancer in skilled nursing facilities
Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers
This study is testing a new palliative care program for older adults with advanced cancer in nursing facilities to see if it helps them and their caregivers make better medical decisions compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 98 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06616298 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of delivering a palliative care intervention called ALIGN to older adults with advanced cancer who are transitioning from acute care hospitals to skilled nursing facilities. Participants will engage in virtual visits with a palliative care social worker every 1-2 weeks during their stay and up to 45 days post-discharge. The study will also focus on preparing caregivers to make informed medical decisions for their loved ones. Researchers will compare the outcomes of the ALIGN intervention with standard care practices.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 18-98 with stage II-IV solid tumors who are being discharged to a skilled nursing facility in Colorado.
Not a fit: Patients discharging with hospice care or those without a legal surrogate decision-maker may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of palliative care for older adults with advanced cancer and support their caregivers in decision-making.
How similar studies have performed: While similar palliative care interventions have shown promise, this specific approach in skilled nursing facilities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients Inclusion Criteria: 1. Adults between 18-98 years 2. Stage I-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. 8. Must have an email address or caregiver with an email address to facilitate communication during the trial Exclusion Criteria: 1. Discharging with hospice care 2. Age less than 18 3. Lacking capacity without a legal surrogate decision maker or proxy. 4. Limited English proficiency 5. Hospitalized for a planned admission or procedure 6. 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: 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. 4. 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: 1\. Working at a SNF that cared for a patient who received the ALIGN intervention Exclusion Criteria: 1\. Not employed by a community SNF where patients were discharged to during the pilot trial PCSW Inclusion Criteria: 1\. PCSWs who conducted the ALIGN intervention and consent to an interview
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Sarguni Singh, MD — University of Colorado, Denver
- Study coordinator: Sarguni Singh, MD
- Email: sarguni.singh@cuanschutz.edu
- Phone: 503.703.0797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.