What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy and radiation therapy, often lead to a range of side effects. Chemotherapy can cause fatigue, nausea, vomiting, hair loss, and an increased risk of infections due to lowered white blood cell counts. Radiation therapy may result in skin irritation, fatigue, and localized pain. Both treatments can contribute to long-term issues such as lymphedema, reduced physical fitness, and decreased quality of life. Integrative approaches, including physiotherapy and exercise programs, have shown promise in mitigating these side effects, improving physical fitness, and enhancing overall quality of life for patients.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that aim to improve physical fitness, reduce treatment-related symptoms, and enhance quality of life. Notable approvals include trastuzumab (Herceptin) for HER2-positive breast cancer, which has shown efficacy in reducing tumor size and improving survival rates. Additionally, the combination of BRAF and MEK inhibitors, such as dabrafenib and trametinib, has been approved for BRAF V600E-mutated tumors, demonstrating significant response rates. These treatments, along with supportive therapies like exercise and physiotherapy, contribute to better overall outcomes for breast cancer patients.

What other types of research exist?

Promising alternatives to an integrated physiotherapy and exercise program via eHealth application for breast cancer patients include: 1) Blended physiotherapy interventions combining in-person sessions with web-based applications, which have shown cost-effectiveness and improvements in quality-adjusted life years (QALYs) and physical functioning in patients with osteoarthritis. 2) Digitally delivered exercise and education programs, which have demonstrated significant improvements in low back pain outcomes and could be adapted for breast cancer patients. 3) Structured exercise programs, such as aerobic activity and progressive resistance training, which have been effective in improving quality of life in head and neck cancer survivors and could be beneficial for breast cancer patients as well.

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Behavioral Intervention

Mobile App-Based Exercise for Breast Cancer (Empower Trial)

N/A

Waitlist Available

Led By Margaret McNeely

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

adult females with a diagnosis of breast cancer (Stage Ic-III);

Have completed cancer surgery involving a mastectomy or breast conserving surgery involving either an axillary lymph node dissection or sentinel lymph node biopsy

Must not have

Are scheduled to undergo neoadjuvant chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combined physical therapy and exercise program delivered via a mobile app for breast cancer patients undergoing chemotherapy. The program aims to improve fitness and manage symptoms through guided exercises and educational content.

Who is the study for?

This trial is for adult women with breast cancer stages Ic-III who've had surgery and are starting or have started chemotherapy. They must speak English, be able to do mild exercise, and commit to a 10-week virtual program. It's not for those without internet/smart device access or undergoing neoadjuvant chemotherapy.

What is being tested?

The study tests an eHealth app delivering physiotherapy and general exercise programs to see if it's feasible and effective in improving arm function, fitness, symptom management, and quality of life in women with breast cancer during chemotherapy.

What are the potential side effects?

Since the intervention involves general exercises tailored for individuals undergoing chemotherapy, potential side effects may include muscle soreness or fatigue. However, these activities are designed considering patients' conditions to minimize discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman diagnosed with Stage Ic-III breast cancer.

Select...

I have completed surgery for cancer that involved removing my breast or part of it and checking the lymph nodes.

Select...

I am a woman diagnosed with Stage Ic-III breast cancer.

Select...

I have had surgery for cancer that removed either my breast or part of it and checked the lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion rate

Secondary study objectives

Arm volume

Attendance rate

Balance

+17 more

Other study objectives

Core muscular endurance (optional)

Grip strength (optional)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated physiotherapy and exerciseExperimental Treatment1 Intervention

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules.

Group II: Standard exercise programActive Control1 Intervention

Participants in this group will take part the general exercise program delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

general exercise

2020

N/A

~120

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves removing the tumor and possibly surrounding tissue, which can directly reduce cancer burden. Chemotherapy uses drugs to kill rapidly dividing cancer cells but can also affect healthy cells, leading to side effects like fatigue and reduced physical fitness. Radiation therapy uses high-energy rays to target and kill cancer cells, which can also cause fatigue and skin changes. Hormone therapy blocks hormones that fuel certain types of breast cancer, while targeted therapy focuses on specific molecules involved in cancer growth. Integrating physiotherapy and exercise via eHealth applications can mitigate these side effects by improving physical fitness, reducing fatigue, and enhancing overall quality of life, making it a valuable adjunct to traditional treatments.

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses.