Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2023-07-05
2024-08-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study Aims:
1\. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Assigning windows of time within the day to complete exercise (e.g. 5-10am exercise start time vs. 3-8pm exercise start time) will be feasible among this patient population.
1a. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Engaging in exercise at an assigned time-of-day will be acceptable in this patient population.
2\. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables. Tests to be conducted at baseline and end of study to measure physical function and human performance variables include: Timed up and go test, 30-second chair stand, handgrip strength, cardiorespiratory fitness.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At baseline and end of study assessments, participants will complete the following physical tests to evaluate physical function, strength, and cardiorespiratory fitness: timed up and go test, 30-second chair stand test, handgrip strength test, cardiorespiratory fitness test. These tests and assessments will be carried out with the Huntsman Cancer Institute (HCI) Wellness Center's Personal Optimism With Exercise Recovery (POWER) program. These tests will occur at the HCI Wellness Center gym. At the end of study assessments participants will also be asked to complete an exit survey, and two short questionnaires related to sleeping and eating habits.
Participants will complete two personalized resistance exercise training sessions supervised by a Cancer Exercise Specialist via the telehealth platform in the electronic medical record. These resistance training sessions are part of the POWER program. Participants will also be required to engage in weekly, moderate-intensity aerobic exercise, with the goal of completing 90 minutes of aerobic exercise per week. The type of aerobic exercise engaged in (e.g., walking, biking, hiking, etc), and location to complete the aerobic exercise (e.g., at home, local park, local gym, HCI Wellness Center gym, etc.) is the participant's choice. Participant's will be required to submit weekly aerobic exercise training logs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Morning Group
Participants must start their exercise between the hours of 5am and 10am.
Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.
Evening Group
Participants must start their exercise between the hours of 3pm and 8pm.
Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise Timing Groups
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ECOG 0, 1, 2
Exclusion Criteria
* ECOG \>/= 3
* Stage I-III Breast Cancer patients who do not have plans to start chemotherapy or who have received more than one cycle of breast cancer chemotherapy.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adriana Coletta
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adriana M Coletta, PhD, MS, RD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB_00162526
Identifier Type: -
Identifier Source: org_study_id