Clinical trial NCT04282967: Streaming Web-based Exercise At Home: A Pilot Study
Official title: IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Breast Cancer Female
Keywords: Exercise
Breast Cancer Survivor
Prostate Cancer Survivor
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.


Eligibility criteria: Inclusion Criteria:

* Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer.
* For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable.
* For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment.
* Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across.
* Physically able to complete modified Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment.
* Physician clearance to participate in this study. Can be done through review of patients' medical records.
* Ability to read, write, and understand English.
* Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair).
* Ambulatory without assistance.
* Has a clear 5 x 6-foot space at home in which to exercise.
* Age \>18 years.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer.
* Known metastatic disease.
* Grade 3 or higher peripheral neuropathy.
* Major surgery within 3 months of baseline visit.
* Positive pregnancy test for women of child-bearing potential.
* Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician.
* Known allergy to Fitbit device.
* Currently meeting physical activity guidelines (score of \>23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).

Primary outcomes:
measure: Attendance
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Patient consent
timeFrame: 1 day
measure: Manipulation check
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in oxygen uptake (baseline - mid-study visit)
timeFrame: 12 weeks
measure: Changes in oxygen uptake (mid-study visit - end of study visit)
timeFrame: 12 weeks
measure: Changes in oxygen uptake (baseline - end of study visit)
timeFrame: 24 weeks
measure: Changes in strength test (baseline - mid-study visit)
timeFrame: 12 weeks
measure: Changes in strength test (mid-study visit - end of study visit)
timeFrame: 12 weeks
measure: Changes in strength test (baseline - end of study visit)
timeFrame: 24 weeks
measure: Changes in resting heart rate (baseline - mid-study visit)
timeFrame: 12 weeks
measure: Changes in resting heart rate (mid-study visit - end of study visit)
timeFrame: 12 weeks
measure: Changes in resting heart rate (baseline - end of study visit)
timeFrame: 24 weeks
measure: Changes in body composition (baseline - mid-study visit)
timeFrame: 12 weeks
measure: Changes in body composition (mid-study visit - end of study visit)
timeFrame: 12 weeks
measure: Changes in body composition (baseline - end of study visit)
timeFrame: 24 weeks
measure: Subjective impact
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Celina Shirazipour, PhD
role: PRINCIPAL_INVESTIGATOR
References: