Assessment Tool for Cancer Care Planning

Recruiting at 7 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Chemotherapy

Disqualifiers: Non-English speakers, Phase I trial, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

1062 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer. PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is the Assessment Tool for Cancer Care Planning safe for humans?

The research suggests that using a geriatric assessment (a detailed evaluation of an older person's health) to guide cancer care planning is generally safe and can help reduce treatment-related side effects in older adults with cancer. ^{1 2 3 4 5}

How does the Assessment Tool for Cancer Care Planning differ from other treatments for cancer?

The Assessment Tool for Cancer Care Planning is unique because it focuses on a comprehensive evaluation of older cancer patients' health status to tailor treatment plans specifically for them. Unlike standard treatments, it uses a multidisciplinary approach to identify medical, psychosocial, and functional issues, ensuring that the treatment is personalized and considers the patient's overall health and tolerance to cancer therapies. ^{2 6 7 8 9}

What data supports the effectiveness of the Assessment Tool for Older Patients With Cancer treatment?

The research suggests that using assessment tools for older cancer patients helps identify unrecognized problems and allows for targeted interventions, which can improve treatment outcomes and patient compliance. Regular multidisciplinary evaluations can modify treatment plans for a significant portion of patients, enhancing their care. ^{2 6 10 11 12}

Who Is on the Research Team?

Dale William, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with any type of cancer who are about to start a new chemotherapy regimen. They must have confirmed cancer, understand English, and not be enrolled in another phase I clinical trial or this trial previously.

Inclusion Criteria

Pathologically confirmed cancer

Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen

Must be able to understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Patients undergo assessments of functional status, cognition, and complete self-administered questionnaires

1-2 weeks

Treatment

Patients begin planned chemotherapy

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments and questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Assessment Tool for Older Patients With Cancer

Trial Overview The study is testing an assessment tool designed to evaluate cognitive functions and daily activity abilities in older cancer patients. This includes understanding how they think, learn, remember, make judgments during their treatment process.

How Is the Trial Designed?

Group I: Geriatric Assessment Tool Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

As the population ages, there is a growing need for effective tools to assess the functional and overall health status of older cancer patients, which can help oncologists tailor treatment plans more effectively.

Geriatric assessments have been shown to uncover previously unrecognized health issues in older patients, leading to targeted interventions that can improve treatment outcomes and patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaires and instruments for a multidimensional assessment of the older cancer patient: what clinicians need to know? Pallis, AG., Wedding, U., Lacombe, D., et al.[2022]

A systematic review of 725 publications identified at least 528 different outcome assessment instruments used in palliative care, highlighting the lack of consensus on standardized tools for measuring outcomes.

The study found that while many instruments exist across various domains (like quality of life and symptom management), most are not validated, suggesting a need for a unified framework to improve comparability and identify gaps in assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome assessment instruments in palliative and hospice care--a review of the literature. Stiel, S., Pastrana, T., Balzer, C., et al.[2021]

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]

A geriatric assessment (GA) intervention significantly reduced the incidence of moderate to severe symptomatic toxicity in older patients (age ≥ 70) with advanced cancer, as shown in a study of 706 patients.

Patients receiving the GA intervention reported fewer grade ≥ 2 symptoms compared to those receiving usual care (88.9% vs 94.8%), indicating that tailored management recommendations can improve patient experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. Culakova, E., Mohile, SG., Peppone, L., et al.[2023]

In a study of 136 older cancer patients (average age 77), over half were exposed to potentially inappropriate medications (PIMs) and one-third had relevant potential drug-drug interactions (rPDDIs), which increased after starting cancer therapy.

The presence of rPDDIs was significantly associated with severe overall toxicity and specifically with hematological toxicity during treatment, indicating a need for careful medication management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication risks in older patients (70 +) with cancer and their association with therapy-related toxicity. Ortland, I., Mendel Ott, M., Kowar, M., et al.[2022]

A new comprehensive geriatric assessment tool was developed specifically for older patients with advanced cancer, addressing various medical, psychosocial, and functional issues, which is crucial given that 60% of elderly patients may have cancer.

The tool incorporates validated measures across multiple domains, ensuring it is brief, reliable, and valid for use in palliative care settings, with plans for further testing and implementation in a comprehensive geriatric palliative care project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a comprehensive cancer specific geriatric assessment tool. Rao, S., Salins, N., Deodhar, J., et al.[2016]

A systematic review of 9 studies involving older adults (aged ≥65 years) found that eHealth tools for receiving health test results generally improved satisfaction and quality of life, indicating their potential benefit in cancer treatment decision-making.

Challenges such as poorly designed user interfaces and older adults' lack of confidence in using eHealth tools hindered their uptake, highlighting the need for more intuitive designs tailored to this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Medical Information to Older Adults in a Web-Based Environment: Systematic Review. McLean, B., Hossain, N., Donison, V., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Questionnaires and instruments for a multidimensional assessment of the older cancer patient: what clinicians need to know? [2022]

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

Integrating a geriatric evaluation in the clinical setting. [2022]

3. England pubmed.ncbi.nlm.nih.gov

What are we trying to measure? Rethinking approaches to health outcome assessment for the older person with cancer. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Outcome assessment instruments in palliative and hospice care--a review of the literature. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Approach to the older patient with cancer. [2021]

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

Using Geriatric Assessment to Guide Conversations Regarding Comorbidities Among Older Patients With Advanced Cancer. [2023]

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

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. [2023]

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

Medication risks in older patients (70 +) with cancer and their association with therapy-related toxicity. [2022]

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

Geriatric oncology and clinical trials. [2018]

10. India pubmed.ncbi.nlm.nih.gov

Developing a comprehensive cancer specific geriatric assessment tool. [2016]

11. Canada pubmed.ncbi.nlm.nih.gov

Providing Medical Information to Older Adults in a Web-Based Environment: Systematic Review. [2021]

12. France pubmed.ncbi.nlm.nih.gov

[Geriatric assessment: principles and feasibility in oncology]. [2009]