ALIGN for Older Adults With Cancer in SNFs

NCT06616298 | Recruiting

• 2 other identifiers: 24-0548.ccK23AG076866
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Skilled Nursing Facility; Caregiver

Outcome Measures

Primary Outcomes (8)

• Intervention fidelity as assessed by fidelity checklist

  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.

  2.5 years

• Intervention fidelity as assessed by audio-recordings

  Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.

  2.5 years

• Assessment of treatment contamination in community skilled nursing facilities

  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%.

  2.5 years

• The proportion (% total) of screened patients that are eligible for enrollment in the trial

  The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria

  2.5 years

• The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes

  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)

  2.5 years

• The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes

  The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)

  2.5 years

• The proportion (% total) of enrolled patients that are randomized

  The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized

  2.5 years

• The proportion (% total) of enrolled caregivers that are randomized

  The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized

  2.5 years

Secondary Outcomes (15)

• Assessing changes in days at home

  6 months after randomization

• Assessing Changes in hospice length of stay

  6 months after randomization

• Health Care Utilization

  6 months after randomization

• Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)

  At enrollment and then at 1, 3, and 6 months after randomization

• Changes in agreement with health-related outcome statements as assessed by the Attitude Scale

  From enrollment and then 1, 3 and 6 months after randomization

Study Arms (3)

Older patients with advanced cancer

EXPERIMENTAL

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

Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

Caregivers of older patients with advanced cancer

EXPERIMENTAL

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

Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

Control Arm

NO INTERVENTION

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.

Interventions

Assessing and Listening to Individual Goals and Needs (ALIGN) 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; Older patients with advanced cancer

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient-selected
• Age ≥ 18
• English speaking
• Able to complete baseline measures.
• Discharging with hospice care
• Age ≤ 18
• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Health Services Needs and Demand

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Sarguni Singh, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarguni Singh, MD

CONTACT

503.703.0797; sarguni.singh@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 27, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)