ALIGN for Older Adults With Cancer

(ALIGN Trial)

Overseen By Sarguni Singh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Hospice care, Age < 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6-8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new palliative care approach called ALIGN (Assessing and Listening to Individual Goals and Needs) for older adults with advanced cancer transitioning from a hospital to a skilled nursing facility. Researchers aim to determine the effectiveness of this support and gather valuable feedback from patients and their caregivers. The goal is to assist caregivers in making crucial medical decisions for their loved ones if necessary. This trial may suit individuals who speak English, have advanced cancer, and are being discharged from a hospital in Colorado to a nursing facility. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the ALIGN intervention is safe for older adults with advanced cancer?

Research has shown that the ALIGN program is designed to improve care for older adults with cancer. ALIGN includes regular online meetings with a palliative care social worker, helping patients and their caregivers plan and make decisions about their care.

Previous studies have not identified any safety concerns with ALIGN. As a support program, not a medication or surgery, it typically involves fewer risks. Overall, ALIGN aims to ensure that the care patients receive aligns with their wishes, providing comfort to both patients and their families.

For those considering joining the trial, knowing that ALIGN has been used safely may offer reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ALIGN because it focuses on improving the transition of older adults with advanced cancer from the hospital to skilled nursing facilities, which is a critical phase often overlooked in standard care. Unlike traditional cancer treatments that primarily target the disease itself, ALIGN emphasizes a holistic approach, offering enhanced resources for caregivers and providing comprehensive support to both patients and their support networks. This method aims to improve quality of life and streamline care processes, potentially leading to better overall outcomes in a demographic that often faces complex care challenges.

What evidence suggests that the ALIGN intervention is effective for older adults with advanced cancer?

This trial will evaluate the ALIGN program, which studies have shown can improve care for patients with advanced cancer by focusing on what matters most to them. Older adults with advanced cancer and their caregivers will participate in this trial. This approach uses palliative care social workers to ensure the care provided aligns with the wishes of patients and their families. Research indicates that ALIGN enhances communication and decision-making, especially when patients cannot express their medical preferences. Early findings suggest that this program could improve the quality of life for older adults with advanced cancer and provide support for their caregivers. ^{3 6 7 8 9}

Who Is on the Research Team?

Sarguni Singh, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for older adults with advanced cancer who are hospitalized and will be discharged to a skilled nursing facility (SNF), as well as their caregivers. Participants must be willing to have virtual visits with a social worker and provide feedback on their condition up to 6 months after enrolling.

Inclusion Criteria

My chosen caregiver is over 18, speaks English, and can complete initial health measures.

Patients: Discharging from an acute care hospital to a SNF in Colorado

Patients: Must have access to technology for virtual visits

Exclusion Criteria

I am a caregiver under 18, with limited English, discharging a patient to hospice.

SNF Staff: Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ALIGN palliative care intervention, including virtual visits with a social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge.

6-8 weeks

Virtual visits every 1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, providing information about their status at 1, 3, and 6 months after enrollment.

6 months

Assessments at 1, 3, and 6 months

Extension/Long-term follow-up

Participants may continue to be monitored for long-term outcomes and caregiver satisfaction.

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• ALIGN

Trial Overview The ALIGN intervention, which involves regular virtual meetings with a palliative care social worker during the SNF stay and possibly afterwards, is being tested against standard care. The study checks if this can be delivered effectively in SNFs and how it helps prepare caregivers.

How Is the Trial Designed?

Group I: Older patients with advanced cancer Experimental Treatment 1 Intervention

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

Group II: Caregivers of older patients with advanced cancer Experimental Treatment 1 Intervention

Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.

Group III: Control Arm Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., et al.[2022]

As the population ages, there will be an increasing number of older cancer patients, necessitating careful selection of treatment plans based on individual health and resources.

Utilizing comprehensive geriatric assessments can help identify which older patients will benefit from aggressive cancer treatments versus palliative care, ultimately improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to the older patient with cancer. de la Cruz, M., Bruera, E.[2021]

The Spanish-language self-administered geriatric assessment (GA) was found to be feasible, with a 98% completion rate among 181 older Spanish-speaking women with breast cancer, although 41% required assistance to complete it.

The GA demonstrated high reliability (≥0.82) and validity, indicating it is an effective tool for assessing the health of this population, but it highlighted the need for adaptations based on educational levels, as those with lower education took longer and needed more help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Care for Spanish-Speaking Older Adults with Breast Cancer: Feasibility, Reliability, and Validity of a Self-Administered Spanish Language Geriatric Assessment. Soto-Perez-de-Celis, E., Vazquez, J., Kim, H., et al.[2022]

Approximately two-thirds of cancer patients reported unmet supportive care needs at the start of the study, and this persisted with about half still reporting unmet needs after six months, indicating a significant ongoing challenge in patient care.

The strongest predictor of unmet needs at six months was having unmet needs at baseline, suggesting that early identification and intervention are crucial, especially for patients further along in their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of change in unmet supportive care needs in cancer. McDowell, ME., Occhipinti, S., Ferguson, M., et al.[2022]

A nurse-led consultation model using patient-reported outcomes (PRO) measures was found to be feasible and acceptable for identifying unmet healthcare needs in lung cancer patients, with 20 participants involved in the study.

The use of PRO measures allowed patients to discuss sensitive issues and led to small-to-moderate reductions in reported needs over three consultations, indicating that this approach can enhance personalized care in lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient-reported outcome measures to deliver enhanced supportive care to people with lung cancer: feasibility and acceptability of a nurse-led consultation model. Kotronoulas, G., Papadopoulou, C., Simpson, MF., et al.[2018]

Geriatric assessment (GA) is crucial for understanding the medical and supportive care needs of older adults with cancer, but its implementation with management strategies is not well established in this population.

There is a need for rigorous clinical trials to evaluate the effectiveness of GA with management in older cancer patients, as it has shown benefits in non-cancer populations, such as reducing functional decline and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management in cancer care: Current evidence and potential mechanisms for future research. Magnuson, A., Allore, H., Cohen, HJ., et al.[2022]

Assessing the functional status of older adults with cancer is crucial for tailoring treatment plans, as it can influence the choice of therapies and nursing care.

With an aging population and rising cancer rates among seniors, incorporating functional assessments into cancer treatment planning can enhance patient outcomes and support better resource allocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring measures of functional dependence in the older adult with cancer. Goodwin, JA., Coleman, EA.[2006]

The use of a computer-assisted interactive tailored patient assessment (ITPA) tool in oncology significantly improved the documentation of patient symptoms and care, with more symptoms being addressed in the intervention group (75 patients) compared to the control group (70 patients).

Patients in the intervention group experienced a significant reduction in symptom distress and need for symptom management support across multiple categories, demonstrating that the ITPA tool enhances patient-centered care and outcomes in leukemia and lymphoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a computer-supported interactive tailored patient assessment tool on patient care, symptom distress, and patients' need for symptom management support: a randomized clinical trial. Ruland, CM., Holte, HH., Røislien, J., et al.[2021]

The Comprehensive Assessment for My Plan (CHAMP) is a self-reported electronic geriatric assessment tool designed to improve cancer treatment decision-making for older adults (≥65 years), developed with input from 17 older adults and 9 oncology clinicians.

Usability testing showed that both older adults and clinicians found CHAMP user-friendly, covering important health domains such as functional status, cognitive impairment, and nutrition, which may enhance access to geriatric assessments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of an electronic geriatric assessment tool: Comprehensive health assessment for my plan (CHAMP). Cook, S., Munteanu, C., Papadopoulos, E., et al.[2023]

In a study of 9,553 cancer patients, only 43.1% completed patient-reported outcome (PRO) measures, with older patients, males, and those from Hispanic/Latino backgrounds being less likely to participate.

Patients who completed the PRO assessments had a significantly lower risk of emergency room visits (78% reduced risk) and hospitalizations (20% reduced risk), indicating that monitoring symptoms can lead to better clinical outcomes in a diverse patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms and Needs Monitoring in Diverse Ambulatory Oncology Patients: Usage Characteristics and Impact on Emergency Room Visits and Hospitalization. Natori, A., Sookdeo, VD., Koru-Sengul, T., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04882111

ALIGN Intervention in Patients With Advanced Cancer ... This investigator plans to test a palliative care social work led intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) that aims to ...

2. reporter.nih.gov reporter.nih.gov/project-details/11166605

Project Details - NIH RePORTER Her proposal tests the ALIGN (Assessing and Listening to Individual Goals and Needs) intervention which utilizes palliative care social workers to deliver a ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392424005475

Processes Through Which Palliative Care Social Workers ... Explore processes through which ALIGN may improve goal-concordant care to validate the conceptual model grounding the intervention.

4. journals.sagepub.com journals.sagepub.com/doi/10.1089/jpm.2023.0381

A Process Evaluation of a Palliative Care Social Work ... Assessing and Listening to Individual Goals and Needs (ALIGN) is a palliative care social work intervention that aims to improve delivery of goal-concordant ...

5. withpower.com withpower.com/trial/align-for-older-adults-with-cancer-b6bd0

ALIGN for Older Adults With Cancer (ALIGN Trial) 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38563805/

A Process Evaluation of a Palliative Care Social Work ... ALIGN is a palliative care social work intervention that aims to improve delivery of goal-concordant care for hospitalized older adults with cancer discharged ...

7. clinicaltrial.be clinicaltrial.be/en/details/452560?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

ALIGN for Older Adults With Cancer in SNFs The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33181046/

Integrating Palliative Care Social Workers into Subacute ... ... ALIGN (Assessing & Listening to Individual Goals and Needs) intervention in older persons admitted to Skilled Nursing Facility (SNF) and ...

9. liebertpub.com liebertpub.com/doi/10.1089/jpm.2020.0322

Integrating Palliative Care Social Workers into Subacute ... The ALIGN (Assessing & Listening to Individual Goals and Needs) intervention was developed and is led by a collective of palliative social workers (The Holding ...