Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06616298

Conditions

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Assessing and Listening to Individual Goals and Needs (ALIGN)

Study Details

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 ID

NCT06616298

Start date

Feb 24, 2025

Status verified date

Apr, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Older patients with advanced cancer

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

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Intervention fidelity as assessed by fidelity checklist [ Time Frame: 2.5 years ]
  • Intervention fidelity as assessed by audio-recordings [ Time Frame: 2.5 years ]
  • Assessment of treatment contamination in community skilled nursing facilities [ Time Frame: 2.5 years ]
  • The proportion (% total) of screened patients that are eligible for enrollment in the trial [ Time Frame: 2.5 years ]
  • The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes [ Time Frame: 2.5 years ]
  • The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes [ Time Frame: 2.5 years ]
  • The proportion (% total) of enrolled patients that are randomized [ Time Frame: 2.5 years ]
  • The proportion (% total) of enrolled caregivers that are randomized [ Time Frame: 2.5 years ]

Central Contacts and Locations

Central contacts

Sarguni Singh, MD

503.703.0797sarguni.singh@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sarguni Singh, MD

503.703.0797sarguni.singh@cuanschutz.edu

Principal Investigator:

Sarguni Singh, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Skilled Nursing Facility
  • Caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-05.