Home-based exercise intervention for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Breast Cancer+1 More
Home-based exercise intervention - Behavioral
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether exercise can improve the gut microbiome for cancer survivors.

See full description

Eligible Conditions

  • Breast Cancer
  • Malignant Neoplasm of Female Breast

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Home-based exercise intervention will improve 5 primary outcomes and 11 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of At conclusion of 10 week study period.

10 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Change in physical performance
Composition of gut microbiota as measured by fecal samples
Depression and Anxiety measured through specific questionnaire
Fatigue measured through fatigue specific questionnaire
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Post-traumatic stress measured through specific questionnaire
Sleep dysfunction measured through specific questionnaire
Week 10
Feasibility - Participant satisfaction
Baseline
Feasibility - Recruitment
Week 10
Feasibility - Adherence to study protocol activities
Feasibility - Adverse events
Feasibility - Attrition rates

Trial Safety

Trial Design

2 Treatment Groups

Home-based standard attention flexibility/toning control
1 of 2
Home-based aerobic exercise training
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Home-based Exercise Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Home-based aerobic exercise training
Behavioral
home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness.
Home-based standard attention flexibility/toning control
Behavioral
Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based exercise intervention
2015
Completed Phase 4
~410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks after baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 weeks after baseline for reporting.

Who is running the study

Principal Investigator
L. Q. R.
Prof. Laura Q. Rogers,, MD
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-70 years
Women
English speaking
Ambulates without assistance
Willing to avoid taking probiotics during the study
≥1 year post-primary cancer treatment completion
Physician medical clearance
No antibiotics in past 90 days
Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
History of breast cancer stage I, II, or III

Patient Q&A Section

What are common treatments for breast cancer?

"For most patients with early breast cancer, adjuvant therapy would be recommended. In addition, for those with node negative disease, adjuvant chemotherapy should be considered. In general, however, the data suggest that most women with breast cancer do very well using modern treatment options." - Anonymous Online Contributor

Unverified Answer

How does home-based exercise intervention work?

"Home-based exercise interventions can improve physical fitness levels and reduce depressive symptoms in middle-aged women. Physical activity is an important lifestyle factor for maintaining weight control and improving health outcomes in this population." - Anonymous Online Contributor

Unverified Answer

What is home-based exercise intervention?

"The present study provided evidence that home-based exercise may improve QOL among women with BC. However, further research is needed to explore what components of exercise interventions work best for improving QOL and what works best for reducing fatigue/mood disturbance associated with cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in home-based exercise intervention for therapeutic use?

"It is concluded that the HBEF programme is an effective approach to improving physical fitness among patients suffering from various medical conditions. In particular, the HBEF programme has been shown to be effective in reducing fatigue in patients suffering from lung diseases such as COPD." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"One cause could be mammae weakness from an infection that occurred when they were young; another is the action of high doses of estrogen during pregnancy and breastfeeding\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"It is important for all women to know their symptoms and signs of breast cancer as soon as possible. Most often they will tell someone about them but if no one else is aware, then it may be another person in their family who later dies from breast cancer.\n" - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The study concludes that the most recent research shows that new therapies, medications, and treatments are effective in reducing metastases. The paper also provides information about how to choose the type of treatment and referrals to surgeons specializing in breast cancer surgery. It discusses the latest findings regarding the importance of nutrition and exercise in the prevention and management of breast cancer.\n" - Anonymous Online Contributor

Unverified Answer

Has home-based exercise intervention proven to be more effective than a placebo?

"The present study demonstrated that a home-based exercise program was associated with improved HRQOL over time compared to a control group. Home-based exercise programs may provide a viable alternative to conventional care for women recovering from breast cancer surgery." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"The non-diagnosis of breast cancer may be a great loss to the patient, and socioeconomic burden. The great majority of these patients will receive treatment within 3 months, but fewer than 20% will survive 5 years following diagnosis." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Data from a recent study confirmed the existence of familial predisposition to breast cancer. The risk factor profile did not differ significantly between the two groups. Therefore, genetic susceptibility seems to be a more important determinant than environmental factors." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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