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

Trial Summary

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 data supports the effectiveness of the treatment ALIGN for older adults with cancer?

Research shows that using patient-reported outcomes (PRO) to monitor symptoms and needs can improve cancer care by helping healthcare providers better understand and address individual patient needs. This approach has been linked to better patient care and reduced symptom distress, which suggests that ALIGN, focusing on individual goals and needs, may be effective in improving outcomes for older adults with cancer. ^{1 2 3 4 5}

How is the ALIGN treatment different from other treatments for older adults with cancer?

ALIGN is unique because it focuses on assessing and listening to the individual goals and needs of older adults with cancer, using a comprehensive geriatric assessment (GA) to inform treatment decisions. This approach is designed to improve accessibility and decision-making by using a self-reported electronic tool, which is particularly beneficial in settings with limited geriatric resources. ^{6 7 8 9 10}

What is the purpose of this 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 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.

Research Team

Sarguni Singh, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

If I can't make decisions, someone legally allowed will decide for me.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Symptoms and Needs Monitoring in Diverse Ambulatory Oncology Patients: Usage Characteristics and Impact on Emergency Room Visits and Hospitalization. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of change in unmet supportive care needs in cancer. [2022]

3. England 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. [2021]

4. United States 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. [2022]

5. Germany 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. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The development of an electronic geriatric assessment tool: Comprehensive health assessment for my plan (CHAMP). [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management in cancer care: Current evidence and potential mechanisms for future research. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Approach to the older patient with cancer. [2021]

9. Switzerland 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Exploring measures of functional dependence in the older adult with cancer. [2006]