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Trial registered on ANZCTR


Registration number
ACTRN12622000584730
Ethics application status
Approved
Date submitted
26/02/2022
Date registered
20/04/2022
Date last updated
16/06/2023
Date data sharing statement initially provided
20/04/2022
Date results information initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehabilitation and Supportive Care in Oncology Treatment of Breast Cancer (PROActive-B): a feasibility study of women with Breast cancer receiving neoadjuvant chemotherapy
Scientific title
Prehabilitation and Supportive Care in Oncology Treatment of Breast Cancer (PROActive-B): a feasibility study of women with Breast cancer receiving neoadjuvant chemotherapy
Secondary ID [1] 305856 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROActive-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 324391 0
Condition category
Condition code
Cancer 321875 321875 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be enrolled in a multimodal early supportive care program within four weeks of commencing neoadjuvant chemotherapy for breast cancer. The study intervention comprises four main components: exercise, education, holistic nursing +/- medical assessment and complementary therapies. This complex intervention is tailored to the needs and preferences of participants. Participants will receive an initial consultation with a nurse lasting approx 40 minutes (face to face or telehealth based on patient preference), supportive care specialist (as needed) and exercise physiologist to tailor the intervention. Participants will be invited to participate in a core periodised exercise program, delivered by an exercise physiologist using both online and face-to-face (hospital) modes of delivery. The exercise plan includes a periodised model of aerobic, resistance, balance and flexibility prescribed according to a progression model adapted for individual symptoms. Sessions will last up to 60 minutes, 3 times a week for the duration of chemotherapy. Responses to treatment are often unpredictable therefore clinical decision-making will inform changes required. Three education modules will be delivered face-to-face by medical, allied health and complementary therapists. The content of the modules will cover lifestyle, nutrition, mindfulness, yoga, lymphoedema, sexuality and intimacy, and preparing for surgery. Sessions will last up to one hour and delivered as hybrid (ZOOM and face-to-face). Complementary therapies will be delivered at the hospital as required and include yoga, acupuncture, mindfulness, reflexology, oncology massage and lymphedema therapists. continue the program until the completion of their chemotherapy (approx. 20 weeks). All visits and online sessions will be recorded to monitor adherance.
Intervention code [1] 322802 0
Rehabilitation
Intervention code [2] 322803 0
Lifestyle
Intervention code [3] 322804 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330384 0
Acceptability and feasibility will be measured as a composite outcome using this set of four-item measures (Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM))
Timepoint [1] 330384 0
program completion (approx 20 weeks)
Primary outcome [2] 330630 0
Recruitment rates determined by an audit of the study enrolment log.
Timepoint [2] 330630 0
Throughout the recruitment period
Primary outcome [3] 330631 0
Adherence to planned intervention rates determined by an audit of session attendance checklists.
Timepoint [3] 330631 0
At the end of the intervention
Secondary outcome [1] 406060 0
Edmonton Symptom Assessment Score (ESAS)
Timepoint [1] 406060 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), at <1 month post-surgery, and 6 months post-intervention commencement
Secondary outcome [2] 406673 0
Anthropometric data will be assessed as a composite outcome using weight-height ratio and BMI: Height will be measured without shoes to the nearest centimetre at the baseline clinic visit using a SECA electronic stadiometer. Weight will be measured using digital scales, and waist will be measured in light clothing. Waist circumference will be measured in a horizontal plane, midway between the inferior margin of the ribs and the superior border of the iliac crest using a Lufkin W606PM tape measure. BMI will be calculated as kilograms per square meter as a composite of weight and height.
Timepoint [2] 406673 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [3] 406900 0
Safety be assessed as a composite outcome at pre-post exercise timepoints using oxygen saturation (SpO2) heart rate (HR) via pulse oximeter and manual pulse palpation (to detect arrhythmias),
Timepoint [3] 406900 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), 6 months post-intervention commencement and at each face-to-face exercise visit throughout the intervention period.
Secondary outcome [4] 406901 0
Program satisfaction (HeiQ Domain 9)
Timepoint [4] 406901 0
At the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [5] 406902 0
Self-efficacy will be measured using the Brief Cancer behaviour inventory (CBI-I)
Timepoint [5] 406902 0
Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [6] 406903 0
Costs (UK Cancer Cost Questionnaire)
Timepoint [6] 406903 0
Baseline, and 6 months post-intervention commencement
Secondary outcome [7] 406904 0
Program delivery costs will be calculated from all consultation and intervention costs using hospital visit medical record data and study visit data.
Timepoint [7] 406904 0
At the completion of the program (approximately 20 weeks post-intervention commencement)
Secondary outcome [8] 406905 0
Hospital length of stay assessed by accessing patient electronic medical records
Timepoint [8] 406905 0
At the completion of the program (approximately 20 weeks post-intervention commencement)
Secondary outcome [9] 406906 0
Surgical satisfaction (BREAST-Q Breast Cancer - satisfaction module only)
Timepoint [9] 406906 0
Baseline, and 6 months post-intervention commencement
Secondary outcome [10] 406907 0
Surgical complications assessed by accessing the patient electronic medical record: Superficial or Deep Incisional Surgical Site Infection (SSI), full thickness skin dehiscence, seroma or hematoma requiring drainage or surgery, skin necrosis,unplanned readmission, unplanned return to theatre, other complication that requires intervention
Timepoint [10] 406907 0
at <1 month post-surgery,
Secondary outcome [11] 406908 0
Relative dose intensity (RDI) will be calculated as actual/planned. Reasons for dose reduction will be recorded.
Timepoint [11] 406908 0
At the completion of the program (approximately 20 weeks post-intervention commencement)
Secondary outcome [12] 406909 0
Quality of life assessed using the The Functional Assessment of Cancer Therapy - Breast (FACT-B)
Timepoint [12] 406909 0
Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), <4 weeks post-surgery and 6 months post-intervention commencement
Secondary outcome [13] 406910 0
Functional strength/endurance will be measured by 30 second chair stand. This is the calculated as the number of full chair stands (to stand up and sit down) completed in 30 seconds
Timepoint [13] 406910 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [14] 406911 0
Cardiometabolic outcomes will be assessed using blood samples collected for the following markers: glucose, HbA1c, fasting serum insulin, IGF1, Triglycerides, Chol, HDL, LDL, thyroid
Timepoint [14] 406911 0
Baseline, 1 month post-surgery, and 6 months post-intervention commencement
Secondary outcome [15] 406912 0
Micronutrient status will be assessed by collecting blood samples of the following markers Vitamin B12, zinc, Vitamin D, iron studies, folate
Timepoint [15] 406912 0
Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [16] 408222 0
Body composition will be measured using the SOZO bioelectrical spectroscopy (Predicted fat free mass, fat mass and skeletal muscle mass)
Timepoint [16] 408222 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [17] 408223 0
Hospital readmissions assessed by accessing patient electronic medical records
Timepoint [17] 408223 0
At the completion of the program (approximately 20 weeks post-intervention commencement)
Secondary outcome [18] 408224 0
Emergency Department or unplanned outpatient visits accessing patient electronic medical records
Timepoint [18] 408224 0
At the completion of the program (approximately 20 weeks post-intervention commencement)
Secondary outcome [19] 408225 0
Surgical histopathology assessed by accessing the patient medical record
Timepoint [19] 408225 0
at <1 month post-surgery,
Secondary outcome [20] 408229 0
Single leg balance test will be used to assess static postural and balance control. ·The participant holds onto the back of the chair and is instructed to lift the non-supporting leg and close her eyes. The tester will say “1, 2, hands off”. The number of seconds is recorded to the nearest 0.01 seconds from a stopwatch, up to a maximum of 60 seconds.
Timepoint [20] 408229 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [21] 408230 0
Upper and lower body strength will be assessed by finding the greatest amount of weight that can be lifted with good form for the whole range of motion, one time only, using the leg press and seated row.
Timepoint [21] 408230 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [22] 408231 0
Leisure-time physical activity will be assessed using the Godin Leisure time Activity Questionnaire
Timepoint [22] 408231 0
Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), <4 weeks after surgery and 6 months post-intervention commencement
Secondary outcome [23] 408232 0
Grip strength will be assessed using a Hand Grip Dynamometer Instruct - the participant squeezes with their maximum strength (the peak red needle will record the highest force exerted.
Timepoint [23] 408232 0
Baseline, mid-program (approximately 10 weeks post-intervention commencement), at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement
Secondary outcome [24] 408233 0
Health Care Professionals (4-5 participants) who are responsible for the delivery of the program' will be recruited via convenience sampling to provide their perceptions in a semi-structured interview regarding the feasibility and value of the program for people with breast cancer.
Timepoint [24] 408233 0
At the completion of the program.

Eligibility
Key inclusion criteria
Study participant Group 1:
1. Female, aged over 18 years, diagnosed with breast cancer.
2. Has been identified as a patient for the NACT pathway by treating breast surgeon and/or medical oncologist.
3. Willingness to provide written consent and able to complete written study assessments and understand instruction for program in English.
Study participant Group 2:
1. HCP participants who have been involved in the program delivery.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Unable to give informed consent
3. Has completed more than 2 cycles of neoadjuvant chemotherapy at time of enrolment
4. Unable to participate due to no computer at home or device to teleconference.
5. Contraindications to participation will be determine based on oncologist and exercise physiologist review based on the PAR-Q and the Exercise and Sports Science Australia. The PAR-Q+ will be used as a preliminary tool. The PAR-Q+ is designed to identify symptoms or conditions requiring medical evaluation before participating in exercise. In this setting, cardiac risk is assessed to determine eligibility for NACT and medical records are reviewed before Exercise Physiology assessment. Additional information will be collected based on recommendations of Exercise and Sports Science Australia. These are outlined below:
• Health history
• physical activity and exercise history
• cancer and non-cancer co-morbidities
• expected treatment related toxicities
• identification of patient capacity and contraindications
• psychosocial and physiological constraints, accessibility, preferences, self-efficacy, barriers and facilitators to exercise
• patient-centred requirements

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
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used for all secondary outcome measures, at all time points measured. Continuous variables, including self-reported measures, will be summarised either as mean (standard error) or median (range), as appropriate. Changes from baseline will be similarly reported. Categorical variables such as surgical complications will be tabulated.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
17/08/2022
Date of last participant enrolment
Anticipated
9/12/2022
Actual
6/06/2023
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
30
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21846 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 36903 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310208 0
Charities/Societies/Foundations
Name [1] 310208 0
SurFebruary
Country [1] 310208 0
Australia
Funding source category [2] 310857 0
Other
Name [2] 310857 0
Private Donors
Country [2] 310857 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse Hospital
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311300 0
None
Name [1] 311300 0
Address [1] 311300 0
Country [1] 311300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309889 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 309889 0
97-105 Boundary Street
Darlinghurst
NSW 2010
Ethics committee country [1] 309889 0
Australia
Date submitted for ethics approval [1] 309889 0
Approval date [1] 309889 0
19/01/2022
Ethics approval number [1] 309889 0
2021/ETH12198

Summary
Brief summary
The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a multimodal early supportive care program delivered during neoadjuvant chemotherapy treatment for women with breast cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned to receive neoadjuvant (i.e. prior to surgery) chemotherapy.

Study details
All participants will receive the supportive care program for the duration of their chemotherapy treatment. The program will involve an holistic nursing assessment, tailored exercise (3x per week), three education modules and complementary therapies (acupuncture, massage etc) prescribed and provided when symptom burden is moderate to severe. Participants will complete a number of questionnaires, tests of physical function, and blood tests at the time of enrolment, mid-program, upon completion of the program, after completion of surgery, and at 6 months post-enrolment, in order to determine the safety, acceptability, and effectiveness of the program.

It is hoped that this study may show that the multimodal early supportive care program is safe, acceptable to patients and their treating clinicians, and effective in modifying side effects of treatment, chemotherapy adherence, anthropometric measures, and selected cardiac, and disease recurrence risk factors, self-efficacy and satisfaction with surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115738 0
Dr Suzanne Grant
Address 115738 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 115738 0
Australia
Phone 115738 0
+61 419126209
Fax 115738 0
Email 115738 0
s.grant@lh.org.au
Contact person for public queries
Name 115739 0
Dr Suzanne Grant
Address 115739 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 115739 0
Australia
Phone 115739 0
+61 419126209
Fax 115739 0
Email 115739 0
s.grant@lh.org.au
Contact person for scientific queries
Name 115740 0
Dr Justine Stehn
Address 115740 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 115740 0
Australia
Phone 115740 0
+61 2 8514 0000
Fax 115740 0
Email 115740 0
justine.stehn@lh.org.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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.