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Trial registered on ANZCTR


Registration number
ACTRN12621001174875
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
31/08/2021
Date last updated
31/08/2021
Date data sharing statement initially provided
31/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Living well with secondary breast cancer - the clinical outcomes and patient perceptions of a combined exercise and educational support group.
Scientific title
Living well with secondary breast cancer - the clinical outcomes and patient perceptions of a combined exercise and educational support group.
Secondary ID [1] 304708 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 322724 0
Condition category
Condition code
Cancer 320312 320312 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 321088 0
Rehabilitation
Intervention code [2] 321263 0
Treatment: Other
Intervention code [3] 321298 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328163 0
Quality of Life will be measured using the European Organisation for Research and Treatment of Cancer QLQ Cancer (EORTC QLQ-30).
Timepoint [1] 328163 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Primary outcome [2] 328380 0
Quality of Life will also be measured using the European Organisation for Research and Treatment of Cancer QLQ Breast Cancer (EORTC QLQBR23).
Timepoint [2] 328380 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks.
Secondary outcome [1] 397900 0
Pain will be measured using the Brief Pain Inventory short form (BPI-sf).
Timepoint [1] 397900 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [2] 397901 0
Psychological and emotional symptoms will be measured using the Distress thermometer.
Timepoint [2] 397901 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [3] 397902 0
Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy Fatigue subscale version 4 (FACIT-F).
Timepoint [3] 397902 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [4] 397903 0
Functional exercise capacity will be measured using the 6-minute walk test (6MWT).
Timepoint [4] 397903 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [5] 397904 0
Lower limb strength will be measured using the 30-second sit-to-stand, a measurement that assesses functional lower extremity strength and endurance. The number of stands completed in 30 seconds is recorded and compared with normative data for age and gender.
Timepoint [5] 397904 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [6] 397905 0
Upper limb strength will be reflected by a measurement of hand grip strength, using a hand dynamometer.
Timepoint [6] 397905 0
Completed prior to commencing the exercise and educational support program and upon conclusion at 8 weeks post-intervention commencement.
Secondary outcome [7] 397906 0
For the qualitative study, participants of the program will be invited to upon completion. Interviews will explore the program acceptibiity and participant perceptions. Questions will include participant experience of the program (positive and negative perceptions) and the influence on emotional and psychological well-being and physical function. Other questions will explore the impact of the program on communication with a support team and the influence on knowledge and self-management strategies. Interviews will be conducted via telephone and will be audio recorded.
Timepoint [7] 397906 0
Completed upon the conclusion of the exercise and educational support program at 8 weeks post-intervention commencement.
Secondary outcome [8] 398814 0
Psychological and emotional symptoms will also be measured using the Depression Anxiety Stress Scales (DASS)
Timepoint [8] 398814 0
Completed upon the conclusion of the exercise and educational support program at 8 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Women with a diagnoses of metastatic breast cancer, deemed appropriate for participation by assessment by the rehabilitation physician.
Minimum age
18 Years
Maximum age
99 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistical analysis will be undertaken using Statistical Package for Social Sciences (v 26.0). Descriptive statistics will be used to describe the data using mean ± SD or median ± interquartile range, depending on the distribution. Pre and post intervention measures for quality of life, functional exercise capacity, upper and lower limb strength, symptoms of pain and fatigue, and measures of anxiety and depression will be analysed using Paired t-tests or Wilcoxon signed rank test, with alpha set at 0.05:

For the qualitative study, interviews will be audiotaped and transcribed verbatim, with transcripts checked for accuracy by the associate investigator. The interviews will be conducted and analysed based on principles of deductive thematic analysis. This approach will obtain an in-depth evaluation of thoughts and feedback from the participants’ responses to questions around pre-determined themes and categories about the exercise and educational support program; according to which the data is evaluated. Analysis will be completed by the research assistant outcome investigator with the chief investigator and associate investigator 1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19928 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 34631 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 309078 0
Hospital
Name [1] 309078 0
Cabrini Health
Address [1] 309078 0
181/183 Wattletree Road, Malvern VIC 3144
Country [1] 309078 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Health
Address
181/183 Wattletree Road, Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 310214 0
None
Name [1] 310214 0
Address [1] 310214 0
Country [1] 310214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308952 0
Cabrini Research Governance
Ethics committee address [1] 308952 0
154 Wattletree Road, Malvern VIC 3144
Ethics committee country [1] 308952 0
Australia
Date submitted for ethics approval [1] 308952 0
Approval date [1] 308952 0
22/10/2020
Ethics approval number [1] 308952 0

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112450 0
Ms Danielle Feil
Address 112450 0
Cabrini Health 181/183 Wattletree Road, Malvern VIC 3144.
Country 112450 0
Australia
Phone 112450 0
+61 418571352
Fax 112450 0
Email 112450 0
dfeil@cabrini.com.au
Contact person for public queries
Name 112451 0
Ms Danielle Feil
Address 112451 0
Cabrini Health 181/183 Wattletree Road, Malvern VIC 3144.
Country 112451 0
Australia
Phone 112451 0
+61 418571352
Fax 112451 0
Email 112451 0
dfeil@cabrini.com.au
Contact person for scientific queries
Name 112452 0
Ms Annemarie lee
Address 112452 0
Cabrini Health 181/183 Wattletree Road, Malvern VIC 3144.
Country 112452 0
Australia
Phone 112452 0
+61 488021266
Fax 112452 0
Email 112452 0
AnnemarieLee@cabrini.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 12440 0
Study protocol
Citation [1] 12440 0
Link [1] 12440 0
Email [1] 12440 0
Other [1] 12440 0
Attachment
Type [2] 12441 0
Informed consent form
Citation [2] 12441 0
Link [2] 12441 0
Email [2] 12441 0
Other [2] 12441 0
Attachment
Type [3] 12442 0
Ethical approval
Citation [3] 12442 0
Link [3] 12442 0
Email [3] 12442 0
Other [3] 12442 0
Attachment
Summary results
No Results