NCT06616298 · University of Colorado, Denver
ALIGN for Older Adults With Cancer in SNFs
(ALIGN)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Assessing and Listening to Individual Goals and Needs (ALIGN)
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.
Primary outcome measures
Intervention fidelity as assessed by fidelity checklist
Time frame: 2.5 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-recordings
Time frame: 2.5 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 facilities
Time frame: 2.5 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 trial
Time frame: 2.5 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 outcomes
Time frame: 2.5 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 outcomes
Time frame: 2.5 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 randomized
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized
The proportion (% total) of enrolled caregivers that are randomized
Time frame: 2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- English speaking
- Able to complete baseline measures. Exclusion Criteria:
- Discharging with hospice care
- 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: 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
- Aurora, Colorado
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations