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

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. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Comprehensive Geriatric Assessment and Management (GAM) for gastrointestinal cancer?

Research shows that elements from a geriatric assessment can predict important outcomes like survival and recovery in older adults with gastrointestinal cancer. Additionally, geriatric assessment and management (GAM) has been shown to improve health outcomes in older adults with cancer in several studies. ^{1 2 3 4 5}

Is the Geriatric Assessment and Exercise program safe for older adults with gastrointestinal cancer?

The Geriatric Assessment (GA) is generally considered safe for older adults, as it helps evaluate their overall health and predict outcomes like treatment risks and benefits. While specific safety data for the exercise component isn't detailed, GA itself is a systematic evaluation that supports safe decision-making in cancer care. ^{1 2 6 7 8}

How is the treatment Comprehensive Geriatric Assessment and Management (GAM) unique for gastrointestinal cancer?

Comprehensive Geriatric Assessment and Management (GAM) is unique because it involves a thorough evaluation of an older patient's overall health, including their physical and mental abilities, other health conditions, nutrition, and social support, to tailor cancer treatment specifically to their needs. This approach helps predict outcomes and optimize care, which is not typically part of standard cancer treatments. ^{1 2 6 7 9}

What is the purpose of this trial?

Phase 2 randomized controlled study using a waitlist control group. The study also has a single arm pre-post test 12-week chair-based exercise arm for those who have received the geriatric assessment in the older adults with cancer clinic (geriatric oncology clinic). Study Duration 2.5 years Study Agent/ Intervention/ Procedure Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.

Research Team

Martine Puts, RN PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Integrating geriatric assessment into routine gastrointestinal (GI) consultation: The Cancer and Aging Resilience Evaluation (CARE). [2021]

3. Netherlands 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. [2023]

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

A randomized phase II trial of geriatric assessment and management for older cancer patients. [2019]

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

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. [2021]

6. Switzerland 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. [2022]

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

Frailty and malnutrition predictive of mortality risk in older patients with advanced colorectal cancer receiving chemotherapy. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Utilisation of geriatric assessment in oncology - a survey of Australian medical oncologists. [2020]