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Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers

NCT ID: NCT06616298Sponsor: University of Colorado, DenverLast updated: 2026-05-05

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.

Arms & interventions

  • OtherAssessing 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.

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: 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%.

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 2.5 years

Secondary

  • Assessing changes in days at home

    Time frame: 6 months after randomization

  • Assessing Changes in hospice length of stay

    Time frame: 6 months after randomization

  • Health Care Utilization

    Time frame: 6 months after randomization

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

    Time frame: 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

    Time frame: From enrollment and then 1, 3 and 6 months after randomization

  • Change in frailty as assessed by the Practical Geriatric Assessment

    Time frame: From enrollment and then 1, 3, and 6 months after randomization

  • Change in Advance Care Planning Documentation

    Time frame: From enrollment and then at 6 months after randomization

  • Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure

    Time frame: At enrollment and then 1, 3, and 6 months after randomization

  • Changes in caregiver coping as assessed by the Brief-Cope Questionaire

    Time frame: At enrollment and 1, 3, and 6 months after randomization

  • Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey

    Time frame: At enrollment and then 1, 3, and 6 months after randomization

  • Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey

    Time frame: At enrollment and then 1, 3, and 6 months after randomization

  • Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment

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

  • Changes in congruence between patient and oncologist understanding of the goals of treatment

    Time frame: At enrollment and then post-intervention protocol completion

  • Assessing Oncology Clinican Acceptability

    Time frame: After completion of the ALIGN protocol

  • Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life

    Time frame: 1 month or later after patient death

Eligibility criteria

Sex: AllAge: 18 Years to 98 YearsHealthy volunteers: No
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 locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Recruiting
Sarguni Singh, MD · Contact
503.703.0797sarguni.singh@cuanschutz.edu
Sarguni Singh, MD · Principal Investigator