Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001271190
Ethics application status
Approved
Date submitted
22/08/2019
Date registered
13/09/2019
Date last updated
3/11/2021
Date data sharing statement initially provided
13/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity adherence, psychological health and immunological outcomes (PAPHIO study) in breast cancer survivors
Scientific title
The effect of self-directed physical activity and motivational interviewing on quality of life, psychological health and immune outcomes in female breast cancer survivors
Secondary ID [1] 299077 0
Nil known
Universal Trial Number (UTN)
U1111-1238-9013
Trial acronym
PAPHIO study
Linked study record
No linked study

Health condition
Health condition(s) or problem(s) studied:
breast cancer survivors 314107 0
Condition category
Condition code
Cancer 312482 312482 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-directed physical activity with wearable step tracker; all participants will be provided with a wearable step counter (Fitbit Alta HR). At the first week, the researcher who is an exercise physiologist will explain the step-count-based activity and how to record their own activity through Fitbit's application via computer or smartphone or they can record in a notebook. Participants will be asked to record their steps daily over a 24 week period. They will wear Fitbit during the daytime or when they are available for physical activity throughout the 24 weeks. They will be advised to perform their activity on their own pace as tolerated and will be advised to gradually increase their daily time spent for physical activity at their perception of taking some effort but can talk during physical activity (the recommendation by the department of health, Australian government).The participants will be advised for safety during physical activity. They will be suggested to stop physical activity if adverse symptoms occur. Supervised physical activity using step tracker at moderate intensity (at their perception of taking some effort but can talk during physical activity) will be done once during the program at the first week and then participants will perform physical activity by their own management and monitoring throughout 24 weeks.They can choose physical activity which they prefer such as walking, jogging and cycling at their home and community.
Motivational interviewing (MI); it is open-end questions, friendly and supportive communication and induction of behavioral changes. The study will apply MI for physical activity motivation. MI will be scheduled during self-directed physical activity for physical activity motivation by 1 time face-to-face (20 minutes per time) and 3 times phone call (15 minutes per time). Participants in group 1 will have motivational interviewing for the first 12 weeks; 1 time face-to-face at week 1 (T1), and 3 times phone call at week 2, 4, and 9. Participants in group 2 will have motivational interviewing for the second 12 weeks; 1 time face-to-face at week 12 (T2), and 3 times phone call at week 13, 15 and 20.
MI sessions will be conducted by a mental health counsellor.
The participants in both groups will cross over at week 12, we decide not to have washout period because we stop MI in experimental group since week 9 (so we assume the effect of MI can be washed out after finishing MI 3 weeks then this group will be started as the control condition)
Intervention code [1] 315344 0
Lifestyle
Intervention code [2] 315345 0
Behaviour
Comparator / control treatment
Comparator: a 12 week self-directed physical activity combining with MI

Control: a 12 week self-directed physical activity without MI

When participants are in control condition, they will perform self-directed physical activity wearing step count tracker.
Control group
Active

Outcomes
Primary outcome [1] 321126 0
Quality of Life (QoL); Score of 4 aspects of QoL (physical, social emotional and functional well-being by FACT-B version 4 questionnaire; a reliable and valid questionnaire consisting of the general parts on cancer (FACT-G) and specific concerns of breast cancer scale to analyse participants’ symptoms and ascertain their QoL.
The change of Qol score after 12 weeks self-directed physical activity combining with MI.

The change of QoL score after 12 weeks self-directed physical activity combining with MI
Timepoint [1] 321126 0
At week 1 (baseline), 12 (primary timepoint) and 24 during physical activity program
Primary outcome [2] 321127 0
Psychological health; Score of the level of stress, anxiety and depression by DASS-21 questionnaire. This measurement is valid to evaluate psychological distress in patients with various cancers.
The change of pyschological health score after 12 weeks self-directed physical activity combining with MI.
Timepoint [2] 321127 0
At week 1 (baseline), 12 (primary timepoint) and 24 during physical activity program
Primary outcome [3] 321128 0
Immune function; The concentration of cell surface biomarkers; CD40, CD80, CD83, CD86, MHC-I, MHC-II, CD14, CD16, CD206, CD209 by peripheral blood mononuclear cells isolation and flow cytometry technique.
This is a composite primary outcome because it is one of primary outcomes and it has combined several outcomes (cell surface biomakers; CD and MHC) in a single measurement (immune function).
The change of concentration of cell surface biomarkers after 12 weeks self-directed physical activity combining with MI.
Timepoint [3] 321128 0
At week 1 (baseline), 12 (primary timepoint) and 24 during physical activity program
Secondary outcome [1] 374062 0
Average daily step count; Participants will record their daily step count from wearable step tracker and researcher can track their daily step by the tracker application in a computer or smartphone. The average daily step count will be calculated at the baseline and every 12 weeks during the program.
Timepoint [1] 374062 0
at week 1 (baseline), 12 and 24 during physical activity program
Secondary outcome [2] 374066 0
Adherence in step tracker usage; The participants’ adherence to self-directed physical activity will be evaluated by their compliance with step tracker. The compliance will be defined as step count tracker wearing time with data capture (daily hours and the number of wearing days)
Timepoint [2] 374066 0
The mean of daily hours and number of wearing days per week will be calculated at the end of week 12 and week 24.
Secondary outcome [3] 374070 0
Exercise self-regulation; the score of self-regulation of exercise assessing external, introjected, identified, intrinsic and amotivated factors by using the behavioral regulations in exercise questionnaire version 2 (BREQ2).
Timepoint [3] 374070 0
At week 1 (baseline), 12 and 24 during physical activity program
Secondary outcome [4] 374072 0
Exercise barrier self-efficacy; the score of the confidence of participants performing exercise when experienced some difficulties by using 9 item-scale- rating barrier self-efficacy
Timepoint [4] 374072 0
At week 1 (baseline), 12 and 24 during physical activity program
Secondary outcome [5] 374407 0
Exercise task self-efficacy; the score of the confidence of participants undertaking 4 challenging exercise by using 4 items rating task self-efficacy.
Timepoint [5] 374407 0
At week 1 (baseline), 12 and 24 during physical activity program

Eligibility
Key inclusion criteria
- Female breast cancer survivors who are within 3 years of diagnosis and at least 6 months post active treatments [stage 0 to III including those with ductal carcinoma in situ (DCIS)] both premenopausal and postmenopausal over the age of 18.
- Survivors on hormonal therapy such as tamoxifen or aromatase inhibitors as well as those on Herceptin (immune targeted therapy) will be eligible.
- Participants who are English literate but we will also include participants who are unable to read/write English but are literate and can speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who are undergoing active treatment (surgery, chemotherapy, and radiation) and those within 6 months of active treatment.
- Known metastatic disease patients.
- Individuals with cognitive impairment and illiteracy to complete the questionnaires.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We justified the sample size of this study regarding the level of significance, power of study, and estimated effect size (Kadam & Bhalerao, 2010). We found that there was large ES of an 12 weeks exercise intervention on the overall score of QoL (by FACT-B assessment) in breast cancer survivors which calculated ES (Cohen’s d) = 2.23 (there was same sample size between groups (N=29) in this randomized controlled with crossover study; mean score between-group difference was 27.9) (Milne et al, 2008). Regarding to our study design; randomised controlled with 2 x 2 crossover design and the hypothesis test for equality, we calculated sample size using software calculator for crossover study. Within participants’ standard deviation of FACT-B score is 13 and minimal difference in mean is 8 (Milne et al, 2008) . Therefore we need a total of 53 participants in this study. We will recruit a total of 64 participants whilst anticipating 20 % drop out rate (32 participants are needed per group).
Repeated measures analysis of variance (ANOVA) will be used to compare physical activity volume by step count, psychological health, the QoL and immune biomarkers of participants at 3 times (T1 to T3) between 2 groups.
Linear-mixed models will be used to identify the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), self-regulation (BREQ2) and self-efficacy at T1, T2 and T3; the relationship between activity volume by step counting and biomarker changes at T1,T2, and T3.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/09/2019
Actual
6/02/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
64
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14606 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 27626 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 303612 0
University
Name [1] 303612 0
Victoria University
Country [1] 303612 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Footscray Park campus, Ballarat road, Footscray. VIC 3011
Country
Australia
Secondary sponsor category [1] 303707 0
None
Name [1] 303707 0
Address [1] 303707 0
Country [1] 303707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304141 0
Melbourne Health HREC
Ethics committee address [1] 304141 0
Office for research, the Royal Melbourne Hospital, Level 2 South west 300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 304141 0
Australia
Date submitted for ethics approval [1] 304141 0
29/10/2018
Approval date [1] 304141 0
29/04/2019
Ethics approval number [1] 304141 0
HREC/45268/MH-2018

Summary
Brief summary
This study will investigate the effect of self-directed physical activity and motivational interviewing on quality of life, psychological health and immune outcomes in female breast cancer survivors.
Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been diagnosed with breast cancer or ductal carcinoma in situ within 3 years and are at least 6 months post-active treatment.
Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in both groups will be administered 2 components of the intervention: a self-directed physical activity component (supplied with a step count tracker) and a motivational interviewing component. The self-directed physical activity component involves one supervised session by an exercise physiologist at the first week and independent physical activity at home or community using a step tracker throughout 24 weeks. The supervised session will be last 30 minutes for the application of step tracker and jogging or walking at moderate intensity exertion (at their perception of taking some effort but can talk during physical activity).
The motivational interviewing components involve a combination of face-to-face and phone calls during self-directed physical activity. The timing of the motivational interviewing component will be randomly allocated to the first 12 weeks or the last 12 weeks.
Quality of life, psychological health and immune function will be assessed using questionnaires and blood tests before, during and after the intervention.
The study hopes to see the benefits of self-directed physical activity combined with motivational interviewing on the improvement of psychological well-being, quality of life and immune outcomes in female breast cancer survivors. So this program implementation could be rolled out more widely at a low cost in the future in female breast cancer survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95938 0
Dr Meron Pitcher
Address 95938 0
176 Furlong Road, Sunshine Hospital, Department of Surgery, St Albans VIC 3021
Country 95938 0
Australia
Phone 95938 0
+61 383456910
Fax 95938 0
Email 95938 0
meron.pitcher@wh.org.au
Contact person for public queries
Name 95939 0
Prof Vasso Apostolopoulos
Address 95939 0
Building C, Footscray Park campus, Victoria University, Ballarat Road, Footscray, 3011, VIC
Country 95939 0
Australia
Phone 95939 0
+61 3 9919 2025
Fax 95939 0
Email 95939 0
vasso.apostolopoulos@vu.edu.au
Contact person for scientific queries
Name 95940 0
Prof Vasso Apostolopoulos
Address 95940 0
Building C, Footscray Park campus, Victoria University, Ballarat Road, Footscray, 3011, VIC
Country 95940 0
Australia
Phone 95940 0
+61 3 9919 2025
Fax 95940 0
Email 95940 0
vasso.apostolopoulos@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The patient’s personal information and health history which are necessary for this research study must be protected for their privacy and confidentiality. The statements of data confidentiality and privacy are indicated in informed consent and clinical trial research agreement between Western health and Victoria University.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4222Study protocol  vasso.apostolopoulos@vu.edu.au
4225Informed consent form  vasso.apostolopoulos@vu.edu.au
4226Ethical approval  vasso.apostolopoulos@vu.edu.au


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.