Mobile Health Exercise for Cancer

(GO-EXCAP2 Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called GO-EXCAP, which provides an exercise program designed to improve physical function and quality of life for older patients with multiple myeloma or other blood cancers undergoing chemotherapy. The trial compares the app's effects with standard chemotherapy education (Behavioral Placebo Control). It also examines the app's impact on fatigue, mood, and certain biological markers related to inflammation. Participants must be 60 or older, have a blood cancer diagnosis, and be receiving outpatient cancer treatment, with no medical issues that prevent exercise. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative research that could enhance cancer care.

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 prior data suggests that the GO-EXCAP Mobile App is safe for older patients with cancer?

Research shows that the GO-EXCAP mobile app is practical and easy to use for older patients with certain blood cancers receiving chemotherapy outside the hospital. Studies have found that the Exercise for Cancer Patients (EXCAP©®) program, included in the GO-EXCAP app, can improve physical abilities and lessen symptoms in cancer patients. Small initial studies tested the program, and participants handled it well. These results suggest that the GO-EXCAP app is safe and may help manage tiredness, mood, and overall quality of life for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional cancer treatments that often focus on medication or surgery, the GO-EXCAP Mobile App is a unique approach because it uses a mobile app to deliver an exercise program specifically designed for cancer patients. This app provides a progressive walking and resistance exercise regimen that is easily accessible, allowing patients to engage in physical activity tailored to their needs. Researchers are excited about this method because it offers a non-invasive way to potentially improve physical fitness and quality of life during cancer treatment, which could be a valuable complement to existing therapies.

What evidence suggests that the GO-EXCAP Mobile App is effective for improving physical function and patient-reported outcomes in older cancer patients?

Research has shown that the GO-EXCAP Mobile App, a treatment under study in this trial, combines a health platform with an exercise program for cancer patients and may improve physical abilities and reduce symptoms. Previous studies found that the EXCAP exercise program helped manage symptoms and reduce inflammation in patients. Early findings suggest that the app is practical and easy to use for older patients with myeloid neoplasms, a type of blood cancer, who are receiving chemotherapy. While more data is needed, initial results are promising for those who want to stay active during treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. ashpublications.org ashpublications.org/bloodadvances/article/6/13/3850/484461/A-single-arm-pilot-study-of-a-mobile-health

A single-arm pilot study of a mobile health exercise ... To improve exercise adherence, we integrated a mobile app with EXCAP (GO-EXCAP) and assessed its feasibility and usability in a single-arm pilot ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9058183/

Protocol for a pilot randomized controlled trial of a mobile ... We have shown the Exercise for Cancer Patients (EXCAP©®) exercise program improved physical function and symptoms and reduced inflammatory markers in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2473952922001859

A single-arm pilot study of a mobile health exercise ... The GO-EXCAP intervention is feasible and usable for older patients with myeloid neoplasms undergoing outpatient chemotherapy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04035499

A Mobile Health Exercise Intervention for Older Patients ... This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid ...

5. oncologynurseadvisor.com oncologynurseadvisor.com/news/myeloid-neoplasm-mobile-exercise-app-feasible-outpatient-chemotherapy/

Mobile Exercise App Feasible During Outpatient ... This study found the GO-EXCAP intervention was feasible among older patients receiving outpatient chemotherapy for myeloid neoplasms. Additional ...

6. withpower.com withpower.com/trial/phase-neoplasms-10-2021-9fe49

Mobile Health Exercise for Cancer (GO-EXCAP2 Trial) Research shows that mobile health exercise programs like GO-EXCAP can improve physical function, mood, and quality of life in cancer patients. These programs ...