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Behavioral Intervention

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

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Empower Trial Summary

This trial will test a new physiotherapy and exercise intervention delivered via an electronic health application to see if it is feasible and effective in helping people with breast cancer undergoing chemotherapy.

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.Check my eligibility
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.See study design
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.

Empower Trial 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.

Empower Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion rate
Secondary outcome measures
Arm volume
Attendance rate
Balance
+17 more
Other outcome measures
Core muscular endurance (optional)
Grip strength (optional)

Empower 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

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,104 Total Patients Enrolled
13 Trials studying Breast Cancer
2,253 Patients Enrolled for Breast Cancer
Margaret McNeelyPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Exercise Rehabilitation Via a Mobile Application (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05254678 — N/A
Breast Cancer Research Study Groups: Standard exercise program, Integrated physiotherapy and exercise
Breast Cancer Clinical Trial 2023: Exercise Rehabilitation Via a Mobile Application Highlights & Side Effects. Trial Name: NCT05254678 — N/A
Exercise Rehabilitation Via a Mobile Application (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254678 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this clinical trial?

"Yes, the information posted on clinicaltrials.gov signifies that this medical trial is currently seeking participants. It was initially announced on October 20th 2022 and has recently been updated on November 9th 2022. This investigation requires 30 volunteers to be recruited from 1 medical facility."

Answered by AI

Is the enrollment phase of this research still open?

"Data revealed on clinicaltrials.gov confirms that the trial is currently seeking participants, beginning October 20th 2022 and last edited November 9th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Alberta
What site did they apply to?
University of Alberta/ Cross Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy
2023. "Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254678.
All > Physical Therapy
~7 spots leftby Jun 2024
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