Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Karen Wonders

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Current standard of care; Other: Supervised, individualized exercise oncology program

Study type: Interventional

Funder types: Other

Identifiers

NCT04106609

Maple Tree Exercise

Details and patient eligibility

About

To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.

Enrollment: 251 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female; determined from electronic medical record
• Initial stage 0, 1 or 2 breast cancer diagnosis within the past 12 weeks determined from electronic medical record
• Age 30-80; determined from electronic medical record
• Physician clearance to participate in exercise

Exclusion criteria

• Participation in supervised physical exercise within 6 months prior to study enrollment
• Currently pregnant or planning to become pregnant
• Non-English speaking
• Unable to make own medical decisions and/or to follow verbal instructions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Exercise Group

Experimental group

Description:

Patients will complete a 60-minute exercise session once per week for 12 weeks. The exercise sessions will be individualized to the patient's needs and fitness level by a trainer. A patient will work with the same trainer throughout the study, who will plan the patient's individualized exercise regimen, and who will provide one-on-one supervision for the duration of each 60-minute session. Each 60-minute session will include cardiovascular, strength, and flexibility training. The intensity level for the aerobic exercise ranges from 30-45% of the individual's predicted VO2max, controlled by heart monitors and lasting 30 min. Strength training will involve a full body workout, with emphasis on all major muscle groups and employing machines, free weights, and resistance tubing. Patients will complete 3 sets of 10 repetitions for each strength exercise. Flexibility training will involve static stretching of all major muscle groups for 15-20 seconds at the completion of each workout.

Treatment:

Other: Supervised, individualized exercise oncology program

Control Group

Active Comparator group

Description:

The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.

Treatment:

Other: Current standard of care