Mobile Health Exercise for Cancer

(GO-EXCAP2 Trial)

Recruiting in Rochester (>99 mi)

Overseen By Becky Gravenstede

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Physical, psychological, social impairments

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

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

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

What data supports the effectiveness of the treatment Mobile Health Exercise for Cancer?

Research shows that mobile health exercise programs like GO-EXCAP can improve physical function, mood, and quality of life in cancer patients. These programs are feasible and usable, especially for older patients, and have been shown to increase activity levels and adherence to exercise regimens. ^{1 2 3 4 5}

Is the Mobile Health Exercise for Cancer treatment safe for humans?

The Mobile Health Exercise for Cancer treatment, including its variations like GO-EXCAP, has been tested in older cancer patients and shown to be feasible and usable, with no significant safety concerns reported. Studies indicate it can improve physical and psychological outcomes without adverse effects, suggesting it is generally safe for human use. ^{2 4 5 6 7}

How is the GO-EXCAP Mobile App treatment different from other treatments for cancer?

The GO-EXCAP Mobile App is unique because it delivers a personalized exercise program specifically designed for older adults with cancer, using a mobile app to improve adherence and track progress, which is not commonly done with traditional cancer treatments. ^{1 2 5 8 9}

Research Team

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for English-speaking older adults (60+) with Myeloid Neoplasms who are undergoing outpatient chemotherapy. They should be able to walk and have an ECOG status of 0-3, indicating varying levels of functional capacity. Those with conditions that prevent exercise or impair participation in the study cannot join.

Inclusion Criteria

English speaking

I can care for myself but may not be able to do heavy physical work.

I am getting or planning to get outpatient cancer treatments.

Exclusion Criteria

Physical, psychological, or social impairments that would interfere with patient's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the GO-EXCAP mobile health exercise intervention or a chemotherapy education control for 12 weeks

12 weeks

Regular virtual check-ins via the mobile app

Follow-up

Participants are monitored for changes in physical function, quality of life, depression, and fatigue after treatment

4 weeks

Treatment Details

Interventions

• Behavioral Placebo Control
• GO-EXCAP Mobile App

Trial Overview The trial is testing a mobile health exercise app called GO-EXCAP against a control group receiving chemotherapy education. The goal is to see if the app improves physical function, mood, fatigue, and quality of life in patients compared to just getting educational support.

Participant Groups

Group I: GO-EXCAP Experimental Treatment 1 Intervention

GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program

Group II: Behavioral Placebo Control Active Control 1 Intervention

Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The pilot study involving 7 colorectal cancer survivors showed that a 12-week mHealth home-based exercise intervention was highly feasible, with an 88.6% workout completion rate and 100% retention, indicating strong participant engagement.

Participants reported improved quality of life and expressed a desire for more intense workouts, suggesting that the intervention was not only safe (with no adverse events) but also positively received, particularly the moderate-intensity continuous exercise (MICE) approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. Moraitis, AM., Rose, NB., Johnson, AF., et al.[2023]

The GO-EXCAP program, a mobile app-based exercise intervention tailored for older adults with myeloid neoplasms, aims to improve physical function and reduce symptoms during outpatient chemotherapy, with a focus on 100 patients aged 60 and older over approximately 12 weeks.

This pilot trial will assess the efficacy of GO-EXCAP compared to a behavioral placebo, measuring outcomes like physical function, fatigue, mood, and quality of life, highlighting the potential of mobile health interventions in enhancing care for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a pilot randomized controlled trial of a mobile health exercise intervention for older patients with myeloid neoplasms (GO-EXCAP 2). Loh, KP., Sanapala, C., Janelsins, M., et al.[2023]

A 12-week program of unsupervised home-based exergaming significantly improved walking distance in patients with prostate cancer undergoing androgen-deprivation therapy, as measured by the 6-minute walking test, compared to usual care.

While exergaming showed benefits in physical function, it did not significantly impact other measures such as leg extensor power, body composition, quality of life, or fatigue, indicating that while it is a safe intervention, its effects may be limited to specific physical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based 'exergaming' was safe and significantly improved 6-min walking distance in patients with prostate cancer: a single-blinded randomised controlled trial. Villumsen, BR., Jorgensen, MG., Frystyk, J., et al.[2023]

The GO-EXCAP intervention, which combines a mobile app with a home-based exercise program, was found to be feasible and usable for older patients (average age 72) with myeloid neoplasms undergoing outpatient chemotherapy, with an 88% retention rate and 82% of patients logging exercise data.

Patients increased their average daily steps from 2848 to 3184 and engaged in resistance exercises for about 26.2 minutes per day, indicating that the program effectively encouraged physical activity despite the challenges older patients face in adhering to exercise regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Loh, KP., Sanapala, C., Watson, EE., et al.[2022]

Digital activity trackers (E-DATs) are feasible for use in cancer survivors, with adherence rates exceeding 70% in most studies, indicating that these tools can help patients stick to exercise regimens.

E-DATs significantly improved step counts, activity levels, and health-related quality of life (HRQoL) in cancer survivors compared to control groups, although they did not show significant changes in certain biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Randomized Controlled Trials of Exercise Interventions Using Digital Activity Trackers in Patients With Cancer. Schaffer, K., Panneerselvam, N., Loh, KP., et al.[2021]

Daily step count monitoring in older adults (aged 65+) undergoing treatment for metastatic prostate cancer was found to be feasible, with a high retention rate of 94% and a participation rate of 52.2%.

A 15% decline in daily steps was associated with the emergence of moderate to severe symptoms, showing good predictive validity (sensitivity of 81.8%), although it was less effective for predicting pain specifically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily physical activity monitoring in older adults with metastatic prostate cancer on active treatment: Feasibility and associations with toxicity. Feng, G., Parthipan, M., Breunis, H., et al.[2023]

The BEAT Cancer intervention significantly reduced fatigue intensity, fatigue interference, depressive symptoms, and anxiety in 222 breast cancer survivors over a 3-month period, with effects lasting up to 6 months post-intervention.

Participants in the BEAT Cancer program experienced clinically meaningful improvements, indicating that this multicomponent physical activity intervention can effectively enhance mental and physical well-being after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multicomponent physical activity behavior change intervention on fatigue, anxiety, and depressive symptomatology in breast cancer survivors: randomized trial. Rogers, LQ., Courneya, KS., Anton, PM., et al.[2022]

Exercise is beneficial and safe for older adults with cancer, and individualized exercise prescriptions can improve their health and well-being.

Oncology providers need to be prepared to discuss the benefits of exercise and help older patients create tailored exercise plans, emphasizing the importance of assessing functional status and making appropriate referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Promotion in Geriatric Oncology. Burhenn, PS., Bryant, AL., Mustian, KM.[2018]

Exercise interventions can effectively address both physical and psychological declines in older cancer patients and survivors, potentially improving their overall cancer-related outcomes.

Despite the known benefits of exercise, it remains underutilized in this population due to barriers and gaps in research, highlighting the need for further studies to promote its acceptance and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing exercise clinical trials for older adults with cancer: Recommendations from 2015 Cancer and Aging Research Group NCI U13 Meeting. Kilari, D., Soto-Perez-de-Celis, E., Mohile, SG., et al.[2019]

References

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

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. [2023]

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

Protocol for a pilot randomized controlled trial of a mobile health exercise intervention for older patients with myeloid neoplasms (GO-EXCAP 2). [2023]

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

Home-based 'exergaming' was safe and significantly improved 6-min walking distance in patients with prostate cancer: a single-blinded randomised controlled trial. [2023]

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

A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. [2022]

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

Systematic Review of Randomized Controlled Trials of Exercise Interventions Using Digital Activity Trackers in Patients With Cancer. [2021]

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

Daily physical activity monitoring in older adults with metastatic prostate cancer on active treatment: Feasibility and associations with toxicity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effects of a multicomponent physical activity behavior change intervention on fatigue, anxiety, and depressive symptomatology in breast cancer survivors: randomized trial. [2022]

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

Exercise Promotion in Geriatric Oncology. [2018]

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

Designing exercise clinical trials for older adults with cancer: Recommendations from 2015 Cancer and Aging Research Group NCI U13 Meeting. [2019]