The goal of this proposed single-group pre-post pilot study is to assess the feasibility and acceptability of the codesigned Nurse-led and GP-supported self-management interventions (NGPS) to reduce cardiovascular risks in breast cancer survivors with cardiovascular diseases. The study will also assess the preliminary effects of the NGPS intervention on various outcomes, such as behavioural, physiological, psychological, and healthcare usage. These outcomes will be measured at three time points, which include the baseline measurement at recruitment (T1-week 1), right after the four weeks' intervention (T2-week 4), and eight weeks after completing the intervention (T3-week 12). The study will be conducted in the primary care centres, and the self-management interventions are behavioural change interventions such as physical activity, diet modifications, tobacco cessation, weight management, eliminating or reducing alcohol consumption, and mind-body exercises such as yoga. The main questions it aims to answer are: 1. What are the recruitment, retention, attrition, and completion rates of participants and potential adverse effects related to the NGPS interventions for the participants throughout the pilot study? 2. What are the adherence rates of the NGPS protocol, participants' response and completion rates of the study instruments during the data collection period of the pilot study? 3. Do this pilot study results indicate any significant differences in cardiovascular health outcomes (e.g., BMI and blood pressure), physical activity, dietary intake, QoL, self-efficacy, anxiety and depression between and across different time points (Baseline (T1), post-intervention (T2), follow-up (T3))?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Self-management interventions will cover physical activity, smoking cessation, weight management, diet modifications, eliminate or reduce alcohol consumption and mind-body exercise such as taichi, yoga.
Greens Medical Group, Dandenong South
Melbourne, Victoria, Australia
Keys Medical Centre, Keysborough
Melbourne, Victoria, Australia
TLC Medical Clinic, Noble Park
Melbourne, Victoria, Australia
Baseline Information
Collect socio-demographic characteristics of the breast cancer survivors such as age, height, race/ethinicity, religion, education level, marital status, employment status and annual household income as well as medical history
Time frame: Once at baseline
Feasibility of recruitment
Number of weeks/months needed to reach target sample size
Time frame: From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months
Recruitment rate
The percentage of eligible (or approached) participants who actually agree to take part in the study.
Time frame: Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).
Retention rate
The percentage of participants who remain in the study
Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up
Dropout rate
The percentage of participants dropped out after the study enrolment
Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up
Feasibility of the questionnaires
The percentage of missing responses for each item and the entire scale in each questionnaires
Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up
Feasibility and acceptability of the study intervention- Adherence rate
The percentage of participants who followed the prescribed interventions as intended
Time frame: From week one to week four, during the intervention period
Safety of the intervention- Adverse Events related to the Nurse-led and GP-supported self-management (NGPS) intervention
Asking the participants to record any discomfort feelings or adverse events related to the NGPS intervention, keeping daily logbook and report via telephone or face-to-face
Time frame: From week one to week four, during the intervention period
Acceptability of the intervention
Feedback on the NGPS program will be gained by using an investigator-created questionnaire. Participants are asked to specify the extent to which they agree with each statement about the intervention by selecting one response option that best indicates their views. The numeric value will range from 1 to 5, where 1 indicates strongly disagree, 2 indicates disagree, 3 indicates neither agree nor disagree, 4 indicates agree, and 5 indicates strongly agree. The minimum value is 1, and the maximum score is 5. Higher scores indicate greater acceptability of the intervention and a better outcome.
Time frame: At eight-week follow up
Physiological outcomes- BMI
Measuring weight in kilograms, height in centimeters and height and weight will be combined to report BMI in kg/m\^2.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-blood pressure
Measuring blood pressure in millimeters of mercury.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-heart rate
Measuring heart rate in beats per minute.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes using 15-item food frequency questionnaire
Behavioural outcome-dietary outcome Dietary outcomes: dietary intake will be measured by using a 15-item Food Frequency Questionnaire. This food frequency questionnaire is widely used in cardiac patients to screen for poor dietary patterns and has an overall good agreement with the diet history. This has been tested in female patients. The dietary intake was captured using frequency-based units with participants reporting their usual consumption of key food groups. The participants will be asked to mark each component on the 15-item food frequency questionnaire to best reflect their dietary pattern based on the scoring system on the scale. During analysis, a summary diet quality score will be calculated, with higher scores indicating better outcomes and healthier dietary patterns.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes- Self-reported smoking status
Behavioural outcome- smoking status Self-reported smoking status. Participants will be asked to report their smoking status by selecting one option that best describes them. The numeric values will be 0, 1 and 2. O indicates never smoked (have never smoked cigarettes or tobacco products), 1 indicates former smoker (previously smoked but does not currently smoke), and 2 indicates current smoker (currently smoke cogarettes or tobacco products). The minimum value will be 0, and the maximum value will be 2. Higher scores indicate a poor outcome or greater current exposure to smoking.
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Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire
Behavioural outcome-Physical activity Physical activity: it will be measured by using the International Physical Activity Questionnaire (IPAQ). This IPAQ is a well-validated tool in Australian adults and has good reliability and validity for assessing physical activity in breast cancer survivors. IPAQ data will be collected minutes per day or hours per day and converted to MET-minutes per week for analysis. Responses will be scored and classified according to established IPAQ scoring guidelines into one numeric value of 1-3 based on reported frequency, duration, and intensity of physical activity. The numeric value of 1 indicates low physical activity, 2 indicates moderate physical activity, and 3 indicates high physical activity. The minimum value is 1, and the maximum value is 3. Higher scores indicate better outcomes or greater levels of physical activity.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Self efficacy
Psychological outcome: Self-efficacy: It will be measured by using the General Self-Efficacy Scale (GSES). This 10-item scale will measure patients' beliefs in their ability to cope with various challenging situations. GSES demonstrated high reliability and validity across a range of populations. The GSES uses a 4-point Likert response scale yielding a total score ranging from 10 to 40, with higher score indicating greater self efficacy.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcomes-Quality of Life
Psychological outcome: Quality of life (QoL): It will be measured by using the Functional Assessment of Cancer Therapy-Breast (FACT-B). This is a targeted QoL measurement tool for breast cancer patients with satisfactory reliability and validity. This tool will assess physical well-being, social well-being, emotional well-being and functional well-being, as well as 10 items for additional concerns. The FACT-B uses a 5-point Likert response scale (0-4)across its subscales, with the summed score representing breast cancer specific QoL.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Anxiety and Depression
Psychological outcome: Anxiety and depression: They will be measured by using the well-established 14-item Hospital Anxiety and Depression Scale (HADS). HADS is a widely adopted tool in various populations, including cancer patients and primary healthcare settings. The HADS uses a 4-point Likert scoring system (0-3), yielding subscale scores from 0-21 for anxiety and depression.
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Healthcare usage
When a participant uses health services related to the cardiovascular conditions such as hospital visits and GP visits will be recorded using an investigator created logbook.
Time frame: From week one to week four, during the intervention period and at eight week follow-up