AzTrials
AzTrials

Advanced CancerALIGNNCT06616298

ALIGN for Older Adults With Cancer in SNFs

A study testing Assessing and Listening to Individual Goals and Needs (ALIGN) in people with Advanced Cancer, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 98 years
Conditions the study is for
Advanced Cancer
What is being tested?
Assessing and Listening to Individual Goals and Needs (ALIGN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
24 Feb 2025to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 98 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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
  • Patient-selected
  • Age ≥ 18
  • English speaking
  • Able to complete baseline measures.
  • 1. Working at a SNF that cared for a patient who received the ALIGN intervention
  • 1. PCSWs who conducted the ALIGN intervention and consent to an interview

Who cannot join

  • 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
Show all 14Show fewer
  • Caregivers
  • 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
  • SNF Staff
  • 1. Not employed by a community SNF where patients were discharged to during the pilot trial
  • PCSW

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Sarguni Singh, MD, 503.703.0797, sarguni.singh@cuanschutz.edu

    Sarguni Singh, MD

    Recruiting

Other trials in United States

About this study

Official title: 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?
Read more

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
Being tested
Assessing and Listening to Individual Goals and Needs (ALIGN)
Keywords
Skilled Nursing Facility, Caregiver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06616298
Study groupRoleWhat they receive
Older patients with advanced cancerExperimentalOlder adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).
Receives: Other: Assessing and Listening to Individual Goals and Needs (ALIGN)
Caregivers of older patients with advanced cancerExperimentalCaregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.
Receives: Other: Assessing and Listening to Individual Goals and Needs (ALIGN)
Control ArmNo interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2.5 years

  2. Intervention fidelity as assessed by audio-recordings

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

    Measured: 2.5 years

  3. 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%.

    Measured: 2.5 years

  4. 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

    Measured: 2.5 years

  5. 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)

    Measured: 2.5 years

  6. 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)

    Measured: 2.5 years

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

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

    Measured: 2.5 years

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

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

    Measured: 2.5 years

Secondary outcomes (15)
  1. 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.

    Measured: 6 months after randomization

  2. 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

    Measured: 6 months after randomization

  3. Health Care Utilization

    Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected

    Measured: 6 months after randomization

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: From enrollment and then at 6 months after randomization

  8. 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.

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

  9. 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.

    Measured: At enrollment and 1, 3, and 6 months after randomization

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

    Measured: At enrollment and then post-intervention protocol completion

  14. 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.

    Measured: After completion of the ALIGN protocol

  15. 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.

    Measured: 1 month or later after patient death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start24 Feb 2025
  3. Primary completion24 Aug 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616298
Sponsor's protocol ID
24-0548.cc
Other IDs
K23AG076866
Acronym
ALIGN
Status last verified
Apr 2026
First submitted
12 Sep 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Assessing and Listening to Individual Goals and Needs (ALIGN) in people with Advanced Cancer, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarguni Singh, MD (503.703.0797, sarguni.singh@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention fidelity as assessed by fidelity checklist (time frame: 2.5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in