Geriatric Assessment and Exercise for Gastrointestinal Cancer

(SOAR Trial)

Recruiting at 1 trial location

Overseen By Martine Puts, RN PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Martine Puts

Disqualifiers: Dementia, Recent geriatrician visit, others

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

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a specialized assessment and exercise program can assist older adults with certain types of cancer. Participants will receive a Comprehensive Geriatric Assessment and Management (GAM) plan, combined with a 12-week online chair-based exercise program and health education. The study will investigate whether this combination can improve quality of life during chemotherapy or immunotherapy. It suits individuals aged 65 and over who have cancers such as lung or gastrointestinal, are undergoing chemotherapy or immunotherapy, and are not very active. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer care for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Comprehensive Geriatric Assessment and Management (GAM) improves care outcomes for older adults with cancer, providing better, more personalized care. No major safety concerns have been reported with GAM itself. It involves thorough health check-ups and planning to help doctors understand and meet an older adult's health needs.

For the exercise component, research shows that physical activity is safe and beneficial for cancer patients. It can reduce treatment side effects and lessen fatigue, and it might even help people live longer after cancer treatment. Studies indicate that regular exercise increases the chance of staying cancer-free.

Health education is also part of the treatment. While specific safety data isn't discussed, education generally involves providing information to help patients manage their health better. It's a low-risk element aimed at improving understanding and lifestyle choices.

Overall, previous research findings suggest that the treatments in this trial—GAM, exercise, and health education—are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment and Exercise approach for gastrointestinal cancer because it emphasizes a comprehensive, personalized care plan through the Comprehensive Geriatric Assessment and Management (GAM). Unlike standard treatments that typically focus solely on chemotherapy, immunotherapy, or targeted therapies, this protocol combines geriatric-specific assessments with a virtual, chair-based exercise program and health education. This holistic method aims to not only enhance physical strength and quality of life for older patients but also potentially improve their response to cancer treatment. By integrating remote delivery, it makes the approach more accessible and convenient for elderly patients who may have mobility challenges. This unique focus on personalized, geriatric-centered care could lead to improved outcomes for older patients undergoing cancer treatment.

What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?

Research has shown that a thorough check-up and care plan, known as comprehensive geriatric assessment and management (GAM), can help older adults with cancer. Some studies have found that GAM improves certain health outcomes for these patients. In this trial, participants in the intervention group will receive GAM along with remote exercise and education. Studies indicate that regular exercise can lower cancer risk, improve survival rates, and boost quality of life. Health education, when combined with exercise, further enhances these benefits by increasing patient knowledge and involvement. Overall, these elements together show promise for improving outcomes in older adults with gastrointestinal cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Martine Puts, RN PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for people aged 70 or older with lung or gastrointestinal cancer, starting first or second-line chemo or immunotherapy. Participants must be frail as indicated by a score >3 on the VES-13 survey, have a life expectancy of over 6 months, be physically inactive, and able to understand English. Those with severe dementia or recent geriatrician visits are excluded.

Inclusion Criteria

Have a physician estimated life expectancy of >6 months

Able to speak and understand English

Score >3 (indicating frailty) using the Vulnerable Elders Survey-13 (VES-13)

Exclusion Criteria

Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician

I have seen a geriatrician in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Assessment

Participants undergo a comprehensive geriatric assessment including health, mood, weight loss, vision and hearing, memory, fatigue, pain, and medication review, along with tests for walking, grip strength, and balance.

1 week

1 visit (in-person or virtual)

Treatment

Participants receive a 12-week program of online chair-based exercise and health education, including two weekly group-based exercise sessions via Zoom and weekly health topic discussions.

12 weeks

24 sessions (virtual)

Waitlist Control

Control group receives standard care with the option to receive the intervention after 12 weeks.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of treatment toxicity, grip strength, life space mobility, physical activity, fatigue, quality of life, and healthcare utilization.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Geriatric Assessment and Management (GAM)
• Exercise
• Health Education

Trial Overview The SOAR Study tests if adding Comprehensive Geriatric Assessment and Management (GAM) along with online chair-based exercise and health education can benefit older adults undergoing cancer treatment. It's a Phase 2 study where participants are randomly assigned to start immediately or wait.

How Is the Trial Designed?

Group I: single arm pre-post test study for participants recruited from geriatric oncology clinic Experimental Treatment 1 Intervention

They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment

Group II: Intervention group Active Control 1 Intervention

geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy

Group III: Waitlist control group Active Control 1 Intervention

Wait list, receiving standard of care and option to receive intervention after treatment.

Who Is Running the Clinical Trial?

Martine Puts

Lead Sponsor

Trials

1

Recruited

60+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

A geriatric assessment (GA) tool can be effectively implemented in community oncology clinics, with 339 out of 1088 patients assessed in these settings, demonstrating its feasibility for older adults receiving cancer treatment.

The time taken to complete the GA was comparable between academic and community clinics, suggesting that this assessment can be integrated into routine care without significant delays, although more patients in community settings required assistance with the questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. Williams, GR., Deal, AM., Jolly, TA., et al.[2016]

In a study of 292 cancer patients aged 65 and older, a high prevalence of geriatric conditions was found, including instrumental ADL impairment (78%) and depressive symptoms (65%), indicating significant health challenges in this population.

Mortality rates were notably high, with 38% of patients dying within 3 months and 64% within 12 months, but mortality was primarily linked to cancer-related factors rather than geriatric conditions, suggesting that cancer severity may be a more critical determinant of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. Hamaker, ME., Buurman, BM., van Munster, BC., et al.[2021]

A systematic review of 31 studies indicates that geriatric assessments (GA) are strong predictors of negative outcomes, such as postoperative complications and survival rates, in older patients with gastrointestinal malignancies, particularly colorectal cancer.

Elements of GA, including frailty, are consistently linked to poorer treatment outcomes, suggesting that incorporating GA into clinical practice could improve patient management and outcomes for older adults with GI cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Geriatric Assessment in the Care of Patients with Gastrointestinal Malignancies. Rostoft, S.[2023]

Integrating a patient-reported Geriatric Assessment (GA) in the management of older adults with gastrointestinal cancers is feasible, with 91.2% of eligible patients completing the assessment during their first clinic visit.

The assessment revealed significant impairments in this population, including high rates of dependence in daily activities (54.7%), falls (20.9%), and polypharmacy (74.0%), highlighting the need for tailored care in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating geriatric assessment into routine gastrointestinal (GI) consultation: The Cancer and Aging Resilience Evaluation (CARE). Williams, GR., Kenzik, KM., Parman, M., et al.[2021]

In a study of 143 colorectal cancer patients aged 70 and older, malnutrition and frailty were found to significantly increase the risk of mortality in those receiving palliative chemotherapy, with hazard ratios of 2.76 and 2.72, respectively.

Poor nutritional status, as indicated by the Mini Nutritional Assessment (MNA), was linked to a lower likelihood of completing chemotherapy, suggesting that addressing malnutrition could improve treatment tolerance and outcomes for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty and malnutrition predictive of mortality risk in older patients with advanced colorectal cancer receiving chemotherapy. Aaldriks, AA., van der Geest, LG., Giltay, EJ., et al.[2022]

A survey of 69 Australian medical oncologists revealed that they recognize the importance of geriatric assessments (GA) in optimizing care for older cancer patients, particularly in addressing challenges like comorbidities and functional status.

While most oncologists see the value in incorporating GA and collaborating with geriatricians, they face barriers to access, emphasizing the need for timely reports to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilisation of geriatric assessment in oncology - a survey of Australian medical oncologists. To, THM., Soo, WK., Lane, H., et al.[2020]

In a multicenter randomized controlled trial involving 350 older adults with cancer, the geriatric assessment and management (GAM) intervention resulted in a median of seven recommendations per participant, with an overall adherence rate of 69%.

Adherence varied significantly by recommendation type, with high compliance (98%) for laboratory tests but much lower adherence (28%) for psychosocial and psychiatric referrals, indicating a need for improved strategies to enhance support for mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing geriatric assessment and management for older Canadians with cancer: Adherence to and satisfaction with the intervention, results of the 5C study. Puts, M., Waked, JAA., Strohschein, F., et al.[2023]

In a study of 28 older patients (mean age 78.5 years) with colorectal cancer undergoing chemotherapy, 25% experienced increased dependence in daily activities within 3 months, highlighting the importance of monitoring functional status during treatment.

Deterioration in functional status was linked to significantly shorter overall survival and worsened quality of life, emphasizing the need for regular geriatric assessments to support treatment decisions and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential Geriatric Assessment in Older Patients with Colorectal Cancer during Chemotherapy: Subgroup Analysis of a Prospective, Multicenter Study EpiReal 75. Li, M., Schulte, N., Elting, F., et al.[2022]

A randomized phase 2 trial successfully enrolled 61 older adults (aged ≥70) with various cancers, demonstrating that geriatric assessment and management (GAM) can be feasibly implemented in oncology settings.

Participants who survived at least 6 months after the intervention reported a greater improvement in quality of life compared to those who did not survive as long, suggesting that GAM may enhance well-being in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase II trial of geriatric assessment and management for older cancer patients. Puts, MTE., Sattar, S., Kulik, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147235/

The effectiveness of comprehensive geriatric assessment ... Williams (1987) reported that 79% of CGA patients and 81% of control patients were satisfied with their evaluation and care plan [15].

2. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(25)00062-5/fulltext

Effectiveness of comprehensive geriatric assessment with ... Recently published randomised controlled trials (RCTs) have shown that implementing CGA improves outcomes for older patients with cancer. It ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.12011

Comprehensive geriatric assessment and management for ... CGA was not effective in improving quality of life for older adults receiving cancer treatment in this study.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406823001820

The effect of comprehensive geriatric assessment on care ... This systematic review seeks to evaluate the impact of a 'GA with intervention' or CGA (GA/CGA) on outcomes for older adults with cancer receiving systemic ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05607-9

The value and effectiveness of geriatric assessments for older ... GAs seems to be beneficial for older adults with cancer across some outcomes, with strong evidence demonstrating the impact of GA with management for treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5927346/

Comprehensive geriatric assessment prediction of ... This meta-analysis set out with the aim of identifying the effectiveness of CGA for predicting postoperative complications in gastrointestinal ...

7. esmoopen.com esmoopen.com/article/S2059-7029(24)01426-1/fulltext

Adequate assessment yields appropriate care—the role of ... Several large randomized trials have demonstrated the positive effects of GAM on outcomes in older adults with cancer. •. The ESMO/SIOG Cancer ...

8. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(22)00169-6/fulltext

Integrated Geriatric Assessment and Treatment ... The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear.