ALIGN for Older Adults With Cancer in SNFs

Last updated: April 10, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Treatment

Assessing and Listening to Individual Goals and Needs (ALIGN)

Clinical Study ID

NCT06616298
24-0548.cc
K23AG076866
  • Ages 18-98
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toprovide proxy consent.

  7. Must have access to the technology needed to complete consenting visit andsubsequent intervention visits. This includes internet access through a computer,tablet, or smartphone OR cellular service with adequate allowance of cellularminutes to allow virtual visits (by participant's assessment).

Exclusion

Exclusion Criteria:

  1. Discharging with hospice care

  2. Age less than 18

  3. Lacking capacity without a legal surrogate decision maker or proxy. Patient withlimited 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 interventioncontent 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. (caremanagers, 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 duringthe pilot trial

PCSW

Inclusion Criteria:

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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Assessing and Listening to Individual Goals and Needs (ALIGN)
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
August 01, 2028

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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