None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the safety and feasibility of exercise in women who are either undergoing treatment or have recently completed treatment for Stage II+ breast cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, reside or work in greater Brisbane, and have been diagnosed with stage II+ breast cancer for which you are either still undergoing treatment, or completed treatment within the last 24 months. All participants must also report at least one cancer-related or treatment-related health condition, e.g. fatigue, obesity, high blood pressure etc. Study details All participants in this trial will be randomly allocated (by chance) to receive the exercise program at enrolment, or 12 weeks following enrolment. The exercise program lasts for 12 weeks and involves completing 150 minutes of moderate intensity aerobic and resistance exercise under the guidance of an accredited exercise physiologist (an allied health professional with expertise in prescribing exercise to people with chronic diseases). Supervised session (between 5 and 20 sessions) will be scheduled for a time and location that is convenient to each participant. Participants will be asked to report any side effects of the treatment and complete questionnaires and function/fitness testing to evaluate the exercise program. It is hoped that the findings from this study will inform physicians and patients on the safety and feasibility of exercise in breast cancer patients with a high disease burden, in the hopes that it may be prescribed as a safe and effective adjuvant therapy for these patients to improve function, quality of life and survival.
Interventions
Intervention: The exercise intervention will involve a minimum prescription of 150 minutes of moderate intensity aerobic- and resistance-exercise each week, with the type, intensity and duration per session individualised according to patient’s interests, fitness, presence of treatment-related side effects and co-morbidities. That is, while each woman’s exercise program will be individualised, total exercise dose prescribed per week will be at least 150 minutes of moderate-intensity exercise eac
Intervention: The exercise intervention will involve a minimum prescription of 150 minutes of moderate intensity aerobic- and resistance-exercise each week, with the type, intensity and duration per session individualised according to patient’s interests, fitness, presence of treatment-related side effects and co-morbidities. That is, while each woman’s exercise program will be individualised, total exercise dose prescribed per week will be at least 150 minutes of moderate-intensity exercise each week. For example, patient #1 may accumulate the required exercise dose by walking 3 days/week for 30 minutes and undertaking resistance-based exercise (using machine weights) for 30 minutes on an additional 2 days/week. Patient #2 may exercise (including walking, stationary cycling and resistance-based exercise using hand weights) twice daily for 10-15 minutes. In line with exercise promoted within breast cancer rehabilitation models, the intervention will encourage women to exercise in both a supervised and unsupervised setting. However, given the patient population to be studied, and that safety is a primary outcome of interest, unsupervised sessions will be introduced slowly. Participants will receive a workbook that includes information relating to the exercise program and a logbook to record details about the exercise sessions, as well as presentation of adverse events. All women will perform the supervised sessions at their homes (or another location as specified as convenient for the participant (e.g., local gymnasium) under the supervision of a trained Accredited Exercise Physiologist (AEP). The study is a randomised wait-list study with a two-group design. The wait-list control group will be provided with a modified intervention; that is, the exercise program will be delivered with less face-to-face contact with the AEP (that is, 5 sessions instead of 20 sessions). However, the dose of exercise prescribed will be identical in both groups (150 minutes of moderate-intensity exercise/ week). Group 1 (immediate-intervention group) will attend 20 sessions with an AEP over the 12 weeks (2 sessions per week for the first 8 weeks and 1 session per week for the final 4 weeks). Group 2 (wait-list control) will attend 5 sessions with an AEP over 12 weeks (the five sessions will be scheduled taking into consideration AEP clinical judgement and participant preference). All participants will also complete unsupervised sessions throughout the 12 weeks under the guidance of the AEP.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II+; treated at one of the referring hospitals. The residence criterion will allow for the Accredited Exercise Physiologist (AEP) to travel to participants’ homes for intervention sessions. All participants must be undergoing or have completed treatment within the past 24 months, with the exception of hormone therapy. Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently not meet national physical activity level recommendations (<150 minutes of weekly physical activity) PLUS meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one co-morbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index>25], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper-body morbidity, neuropathy, fatigue, arthralgia). We will also accept self-report of moderate to severe in intensity treatment sequelae, even in the absence of a clinical diagnosis. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care (Cheville et al. 2012). Our self-report measures are ones that we have included our prospective cohort studies.
Exclusion criteria
Exclusion criteria: Currently meeting the current exercise recommendations (i.e., sufficiently active); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) during the study period; unable to consent.
Outcome results
None listed