ALIGN for Older Adults With Cancer in SNFs

NCT ID: NCT06616298

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2028-08-01

Brief 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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Older patients with advanced cancer

Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).

Group Type: EXPERIMENTAL

Assessing and Listening to Individual Goals and Needs (ALIGN)

Intervention Type: OTHER

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.

Caregivers of older patients with advanced cancer

Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.

Group Type: EXPERIMENTAL

Assessing and Listening to Individual Goals and Needs (ALIGN)

Intervention Type: OTHER

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.

Control Arm

Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

1. Patient-selected

2. Age ≥ 18

3. English speaking

4. Able to complete baseline measures.

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)

1. PCSWs who conducted the ALIGN intervention and consent to an interview

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

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

1. Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial

PCSW

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarguni Singh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarguni Singh, MD

Role: CONTACT

sarguni.singh@cuanschutz.edu

503.703.0797

Facility Contacts

Sarguni Singh, MD

Role: primary

sarguni.singh@cuanschutz.edu

503-703-0797

Other Identifiers

K23AG076866

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0548.cc

Identifier Type: -

Identifier Source: org_study_id