None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the feasibility and efficacy of using Fitbit devices in combination with an individual exercise counselling session to increase physical activity in women with stage II+ breast cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, and have been diagnosed with stage II+ breast cancer for which you are either currently undergoing treatment, or have finished treatment within the previous 24 months. Participants must also reside or work in greater Brisbane and be insufficiently physically active. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either an individual exercise counselling session plus use of a Fitbit device for 12 weeks, or to receive only the individual exercise counselling session. The exercise counselling session will involve a 60 minute appointment at an exercise clinic (Queensland University of Technology, Brisbane) with an accredited exercise physiologist to discuss recommended physical activity levels and methods for increasing physical activity. Individuals in the Fitbit group will then be provided with a Fitbit device to use as much as they choose for the following 12 weeks. All participants will then have their physical activity levels assessed (by wearing a small physical activity monitor on their hip) and report on their levels of physical activity in order for researchers to compare between the two groups. It is hoped that the findings from this study will inform physicians and patients on easily accessible, cost-effective and feasible approaches for maintaining physical activity participation in the absence of supervised exercise in breast cancer patients with a high disease burden.
Interventions
The intervention will involve one face-to-face, 60-minute structured physical activity counselling session with an Accredited Exercise Physiologist (AEP), plus provision of a Fitbit physical activity monitor (Fitbit Charge HR, https://www.fitbit.com/au/chargehr) for 12-weeks. The physical activity counselling session will be one-on-one, and conducted at an exercise clinic by an AEP with experience in exercise prescription and supervision for women with stage II+ breast cancer. During this sessio
The intervention will involve one face-to-face, 60-minute structured physical activity counselling session with an Accredited Exercise Physiologist (AEP), plus provision of a Fitbit physical activity monitor (Fitbit Charge HR, https://www.fitbit.com/au/chargehr) for 12-weeks. The physical activity counselling session will be one-on-one, and conducted at an exercise clinic by an AEP with experience in exercise prescription and supervision for women with stage II+ breast cancer. During this session, the AEP will use a patient-centred approach by following the Chronic Disease Self-Management Intervention Model to develop individualised physical activity goals that are consistent with National and International physical activity guidelines for women with breast cancer. During the 60-minute session, the AEP will lead each participant through a study-specific physical activity maintenance handbook that has been developed in accordance with the CDSM. Participants will be informed of current National and International physical activity guidelines for women with breast cancer provided to them in the study handbook and will discuss physical activity goal setting. Specifically, participants will be encouraged to: identify and discuss benefits associated with maintenance physical activity and exercise participation; identify expected benefits remaining physically active; identify forms of motivation to maintain long-term physical activity participation; identify barriers to physical activity participation and use a problem-solving approach to address barriers, and; develop individualised goals that are realistic and measurable. Participants will also be shown how to use the Fitbit physical activity monitor. Following completion of the 60-minute face-to-face physical activity counselling session, participants will use the Fitbit independently to self-monitor and self- manage their physical activity as desired during the 12-week period. Participants will be able to use and access the Fitbit and associated software as desired over the 12 weeks. Adherence to use of the Fitbit will be assessed by evaluating the total number of days and mean number of hours per day the device was worn (obtained via self-report). No additional AEP contact, physical activity counselling or structured sessions with the AEP during the 12-week period (i.e., after completion of the 60-minute physical activity session). Self-reported and objectively assessed physical activity levels will be assessed at baseline and 12-week.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible, women need to be 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+. The residence criterion will allow for the AEP to travel to participants’ homes for intervention sessions. All participants must be currently undergoing treatment, or recently completed treatment (within the past 24 months). Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently be insufficiently physical active (that is, engage in <150 minutes of moderate-intensity physical activity per week), plus meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one comorbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index > 25 kg/m2], 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). Self-report of moderate- to severe-intensity treatment-sequelae, even in the absence of a clinical diagnosis will also be accecpted. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care. These self-report measures are ones that have been included in previous prospective cohort studies. These eligibility criterion will ensure the subgroup of the breast cancer population that have typically been excluded from previous study can participate. That is, this study aims to evaluate women with the characteristics of typical women with later-stage breast cancer.
Exclusion criteria
Exclusion criteria include: being sufficiently active (that is, currently meet the National physical activity recommendations); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) or adjuvant treatment during the study period; unable to provide informed consent.
Outcome results
None listed