ALIGN for Older Adults With Cancer in SNFs (ALIGN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarguni Singh, MD; Phone Number: 503.703.0797; Email: sarguni.singh@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Principal Investigator: Sarguni Singh, MD
      • Contact: Sarguni Singh, MD; Phone Number: 503.703.0797; Email: sarguni.singh@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older patients with advanced cancer; 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); 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.
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.	Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Care Utilization	Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected	6 months after randomization
Change in Advance Care Planning Documentation	Advance Care Planning documents such as Medical Durable Power of Attorney (MDPOA) forms, cardiopulmonary resuscitation (CPR) directives, and the Medical Orders for Scope of Treatment (MOST) forms are documents that communicate end of life wishes for patients and also who they would designate to make medical decisions on their behalf if they are unable to do so themselves. We are measuring completion rates and changes to wishes expressed in these documents in all patients who participate in the trial.	From enrollment and then at 6 months after randomization
Assessing changes in days at home	In this exploratory outcome measure, days at home will be calculated as 180 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.	6 months after randomization
Assessing Changes in hospice length of stay	In this exploratory outcome measures, changes in the length of a hospice stay in both arms of the clinical trial will be measured	6 months after randomization
Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)	In this exploratory outcome measure, patients will be asked to complete this 14 item Likert-type scale that measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Scores range from 0-56. Lower scores indicate lower quality of life.	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	In this exploratory outcome measure, patients will be asked to complete the Attitude Scale which is a 5-point Likert scale that identifies the extent to which patients agree with 8 health-related outcome statements such as: The most important thing to me is living as long as I can, no matter what my quality of life is. Changes in agreement will be measured in both groups of the trial.	From enrollment and then 1, 3 and 6 months after randomization
Change in frailty as assessed by the Practical Geriatric Assessment	In this exploratory outcome measure, patients and caregivers will be asked to complete this 19 item assessment measures individual domain impairments in areas of physical function, nutrition/weight loss, social support, psychological, comorbidities, and cognitive functioning to guide treatment decisions. There is no composite score for this measure, rather scores from each domain help identify impairments. Higher scores in the physical function, comorbidities, psychological health, domain suggest greater impairment. Lower scores in cognitive and nutritional domains suggest greater impairment.	From enrollment and then 1, 3, and 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	In this exploratory outcome measure, patients and caregivers will be asked to complete this 18-item instrument using a 4-point Likert scale. Scores range from 18 -72. Higher scores indicate a greater perception of patient-centeredness of care.	At enrollment and then 1, 3, and 6 months after randomization
Changes in caregiver coping as assessed by the Brief-Cope Questionaire	This scale ascertains how people are responding emotionally to a serious circumstance and will be completed by caregivers in this study as an exploratory outcome measure. Scores are presented over three overarching coping styles (problem-focused, emotion-focused, and avoidant) as average scores indicating the degree to which the respondent has been engaging in that coping style. Scores for each coping strategy can range from 2-8. We will measure changes in coping styles over the course of the trial.	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	In this exploratory outcome measure, this 5 question survey assesses perceived illness understanding and coping support. The range of scores is from 0 - 24 with higher scores indicating increased illness understanding and coping support.	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	In this exploratory outcome measure, this 4 question Likert scale survey will be completed by patients and caregivers to assess how well they felt heard and understood by their oncology team of clinicians. Scores can range from 0-16. Higher scores indicate delivery of higher quality care.	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	In this exploratory outcome measure, caregivers will be asked to complete this 24 item instrument designed to measure the reactions of family members to caring for adults with a variety of illness. The instrument focuses on five dimensions: caregiver esteem, lack of family support, impact on finances, impact on schedule, and impact on health. The minimum score is 0 and the maximum score is 24. A higher score indicates greater caregiver burden.	At enrollment and then at 1, 3 and 6 months after randomization
Assessing Oncology Clinican Acceptability	Involved oncology clinicians will be asked using a Likert scale survey their experience working with the ALIGN social worker conducting the intervention in this exploratory outcome measure.	After completion of the ALIGN protocol
Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life	In this exploratory outcome, bereaved caregivers will be asked to complete a 10-item validated bereaved family survey assessing their satisfaction with end-of-life care received by the patient. Domains assessed will include physical and emotional support, focus on the individual, and shared decision making. Higher scores indicate greater satisfaction with care.	1 month or later after patient death
Changes in congruence between patient and oncologist understanding of the goals of treatment	In this exploratory outcome measure, patients, caregivers, and oncologists will be asked a focus of treatment question (Please select one of the options below that best describes your current focus of treatment) and asked to select from the following options: curative, life prolonging/rehabilitative, or comfort focused. Patients, caregivers, and oncologists will be asked this question at enrollment and when patients are discharged from ALIGN after the protocol has been completed. We are measuring whether there is increased congruence in the response between patient and their oncologists.	At enrollment and then post-intervention protocol completion

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sarguni Singh, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Skilled Nursing Facility; Caregiver
• Additional Relevant MeSH Terms: Delivery of Health Care; Health Care Quality, Access, and Evaluation; Health Care Economics and Organizations; Health Planning; Health Services Research; Health Services Needs and Demand
• Other Study ID Numbers: 24-0548.cc; K23AG076866 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No