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Living well with secondary breast cancer - the clinical outcomes and patient perceptions of a combined exercise and educational support group.

Living well with secondary breast cancer - the clinical outcomes and patient perceptions of a combined exercise and educational support group.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001174875
Enrollment
40
Registered
2021-08-31
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the efficacy and patient perceptions of an 8-week exercise and educational support program for women with metastatic breast cancer in improving disease-specific quality of life, symptoms of anxiety and depression, and exercise capacity, as well as reducing pain and fatigue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have a diagnosis of metastatic breast cancer. Study details All participants will take part in an 8-week program consisting of two 60-minute exercise sessions per week involving aerobic and strength-based exercises, as well as two 60-minute educational support sessions per week. Exercise sessions will be supervised and run at the Cabrini Exercise and Wellness Centre. Once the patient is safely established on a supervised exercise regime, an unsupervised home exercise program will be prescribed for them to complete at home. Educational support sessions will cover a range of topics including mindfulness, energy conservation, superannuation and services, sleep, nutrition and lymphoedema, with the option to ‘opt out’ of particular sessions or request additional one-on-one support sessions with the social worker or psychologist if desired. Participants will be required to fill out a number of questionnaires and perform brief tests of physical function before the start of the program and after completion of the 8-week program. It is hoped that this study will demonstrate that a combined exercise and educational support program is effective for managing undesirable side effects of metastatic breast cancer and its treatment, and at improving functional exercise capacity and quality of life in these patients.

Interventions

Participants will undertake an 8-week individualised outpatient rehabilitation program of exercise and educational support at Cabrini Exercise and Wellness Centre. Exercise sessions will run twice weekly for 60 minutes duration incorporating aerobic and resistance exercises aligned with the Clinical Oncology Society of Australia (COSA) guidelines, which recommends a minimum of 150 minutes of moderate intensity or 75 minutes of vigorous intensity aerobic exercise weekly and two to three resistan

Participants will undertake an 8-week individualised outpatient rehabilitation program of exercise and educational support at Cabrini Exercise and Wellness Centre. Exercise sessions will run twice weekly for 60 minutes duration incorporating aerobic and resistance exercises aligned with the Clinical Oncology Society of Australia (COSA) guidelines, which recommends a minimum of 150 minutes of moderate intensity or 75 minutes of vigorous intensity aerobic exercise weekly and two to three resistance sessions targeting major muscle groups. Exercise recommendations and prescription will be tailored to individual's abilities following the review of the objectively measured outcomes, noting that specific exercise programming adaptations may be required for people based on disease and treatment-related adverse effects, anticipated disease trajectory, their health status and current/previous level of exercise. Aerobic exercise will consist of a combination of treadmill walking, cycling, rowing or elliptical cross trainer, based on patient preference and physiotherapist discretion. Approximately 30 minutes of time will be allocated to the aerobic exercise component. The initial exercise intensity will be set for a moderate intensity exercise, with an exercise stimulus that requires the patient to work at a level of exertion, perceived as 'somewhat hard' a rating of perceived exertion (RPE) of 12-14 on the Borg scale. Starting prescription will be based on the 6-minute walk test, at n intensity of 80% of the average walking speed measured and progressed over time. Exercise prescription will occur under the supervision of a physiotherapist, with the intensity targeted to achieve a score of 12-14 for perceived exertion on the Borg scale. For patients who exercise regularly, exercise intensity may be progressed quicker from moderate to vigorous intensity exercise, with exertion perceived as 'hard to very hard' on the Borg scale, a score of 15-17 and may include running on the treadmill or cycling at a hard pace. The resistance or weight training component of the program will consist of upper limb and lower limb exercises. Examples for lower limbs include squats, step ups, lunges; examples for upper limbs include chest press, push ups and free weights. Following assessment of 10 repetition maximum, the initial load will correspond to 2 sets of 10 repetition maximum, a weight that can be lifted correctly and comfortably, twice 10 times and elicits a RPE of 12-14 on the Borg scale. If a participant is considered at risk or have bony metastases, resistant training will be modified under the guidance of the therapist. Strengthening exercises will be progressed to maintain a RPE score of 12-14, with a progression of set number, followed by weight. Approximately 30 minutes will be allocated to the resistance component for each individual, with the target goal of completing 2 resistance training sessions per week. Once the patient is safely established on a supervised exercise regime, an unsupervised home exercise program will be prescribed to achieve guidelines as recommended by COSA. Patients will be educated on monitoring symptoms and their level of exertion and will be instructed to exercise at an intensity level similar to that achieved in the supervised session. Frequency of unsupervised exercise will be determined by the patients function and capabilities, commencing once a week gradually increasing to three times per week. For the exercise component of the intervention, adherence will be monitored by marking session attendance and indicating individual exercises completed within a session. This will assist in monitoring progress or change. The educational support program will run twice weekly for 60 minutes (2 x 60 minute sessions), delivered by an interdisciplinary team including exercise physiologists, physiotherapists, breast care nurse, health psychologist, occupational therapist, dietitian and social worker. The educational support program will be delivered directly following the each exercise session. Weekly educational topics will include mindfulness, energy conservation, superannuation and services, sleep, nutrition and lymphoedema. Educational sessions will be delivered via a pre-planned didactic presentation, face to face. The content has been determined in consultation with professionals and patient advocates. Individuals will have the opportunity to ask questions and have a guided discussion with peers in a safe environment, reflecting upon the information presented. The once weekly emotional supportive elements of the program will be facilitated by a health psychologist, covering themes including relationships, sexuality and psychological flexibility. Participants who feel uncomfortable about a specific topic have the ability to 'opt out' if they do not wish to attend a particular session. Participants who are identified by clinicians or self-identified as benefiting or requiring additional support or guidance, or who do not want to discuss a topic within the group, can organise a one-on-one session with the social worker or psychologist to further explore issues uncovered. Adherence to the educational component will be monitored by marking session attendance

Sponsors

Cabrini Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

Women with a diagnoses of metastatic breast cancer, deemed appropriate for participation by assessment by the rehabilitation physician.

Exclusion criteria

Nil exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026