ANZCTR - Registration

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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

PROActive-B

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer

Condition category

Condition code

Cancer

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]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

program completion (approx 20 weeks)

Primary outcome [2]

Recruitment rates determined by an audit of the study enrolment log.

Timepoint [2]

Throughout the recruitment period

Primary outcome [3]

Adherence to planned intervention rates determined by an audit of session attendance checklists.

Timepoint [3]

At the end of the intervention

Secondary outcome [1]

Edmonton Symptom Assessment Score (ESAS)

Timepoint [1]

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]

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]

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]

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]

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]

Program satisfaction (HeiQ Domain 9)

Timepoint [4]

At the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement

Secondary outcome [5]

Self-efficacy will be measured using the Brief Cancer behaviour inventory (CBI-I)

Timepoint [5]

Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement

Secondary outcome [6]

Costs (UK Cancer Cost Questionnaire)

Timepoint [6]

Baseline, and 6 months post-intervention commencement

Secondary outcome [7]

Program delivery costs will be calculated from all consultation and intervention costs using hospital visit medical record data and study visit data.

Timepoint [7]

At the completion of the program (approximately 20 weeks post-intervention commencement)

Secondary outcome [8]

Hospital length of stay assessed by accessing patient electronic medical records

Timepoint [8]

At the completion of the program (approximately 20 weeks post-intervention commencement)

Secondary outcome [9]

Surgical satisfaction (BREAST-Q Breast Cancer - satisfaction module only)

Timepoint [9]

Baseline, and 6 months post-intervention commencement

Secondary outcome [10]

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]

at <1 month post-surgery,

Secondary outcome [11]

Relative dose intensity (RDI) will be calculated as actual/planned. Reasons for dose reduction will be recorded.

Timepoint [11]

At the completion of the program (approximately 20 weeks post-intervention commencement)

Secondary outcome [12]

Quality of life assessed using the The Functional Assessment of Cancer Therapy - Breast (FACT-B)

Timepoint [12]

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]

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]

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]

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]

Baseline, 1 month post-surgery, and 6 months post-intervention commencement

Secondary outcome [15]

Micronutrient status will be assessed by collecting blood samples of the following markers Vitamin B12, zinc, Vitamin D, iron studies, folate

Timepoint [15]

Baseline, at the completion of the program (approximately 20 weeks post-intervention commencement), and 6 months post-intervention commencement

Secondary outcome [16]

Body composition will be measured using the SOZO bioelectrical spectroscopy (Predicted fat free mass, fat mass and skeletal muscle mass)

Timepoint [16]

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]

Hospital readmissions assessed by accessing patient electronic medical records

Timepoint [17]

At the completion of the program (approximately 20 weeks post-intervention commencement)

Secondary outcome [18]

Emergency Department or unplanned outpatient visits accessing patient electronic medical records

Timepoint [18]

At the completion of the program (approximately 20 weeks post-intervention commencement)

Secondary outcome [19]

Surgical histopathology assessed by accessing the patient medical record

Timepoint [19]

at <1 month post-surgery,

Secondary outcome [20]

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]

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]

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]

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]

Leisure-time physical activity will be assessed using the Godin Leisure time Activity Questionnaire

Timepoint [22]

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]

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]

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]

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]

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

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]

Chris O’Brien Lifehouse - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

SurFebruary

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Private Donors

Country [2]

Australia

Primary sponsor type

Hospital

Name

Chris O'Brien Lifehouse Hospital

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

97-105 Boundary Street 
Darlinghurst
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/01/2022

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Suzanne Grant

Address

Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 419126209

Email

[email protected]

Contact person for public queries

Name

Suzanne Grant

Address

Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 419126209

Email

[email protected]

Contact person for scientific queries

Name

Justine Stehn

Address

Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8514 0000

Email

[email protected]

Trial Review

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