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NCT Number: NCT07313397

Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors

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))?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Greens Medical Group, Dandenong South, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 years or older
  • confirmed diagnosis of breast cancer at stage I, II, or IIIa
  • confirmed diagnosis of CVDs, such as heart failure, hypertension, coronary artery disease, cerebrovascular accidents (e.g., stroke, transient ischemic attack), cardiomyopathy and arrhythmias.
  • able to read, write, and communicate in English
  • have completed active anticancer treatment including chemotherapy and radiotherapy, and are receiving regular healthcare in a primary care centre from GP/practice nurses and are willing to participate in the research study and provide informed consent.

Exclusion criteria

  • patients with unstable health conditions with mental health issues or critically ill patients unable to participate in physical activities (e.g., suffering from life-threatening diseases, extremely weak), cognitive impairment, currently involved in another research study, or scheduled anticancer treatment during the study period.

Treatment and study plan

Self-management Interventions

Other

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.

Primary outcomes

  1. Baseline Information

    Time frame: Once at baseline

    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

  2. Feasibility of recruitment

    Time frame: From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months

    Number of weeks/months needed to reach target sample size

  3. Recruitment rate

    Time frame: Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).

    The percentage of eligible (or approached) participants who actually agree to take part in the study.

  4. Retention rate

    Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up

    The percentage of participants who remain in the study

  5. Dropout rate

    Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up

    The percentage of participants dropped out after the study enrolment

  6. Feasibility of the questionnaires

    Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up

    The percentage of missing responses for each item and the entire scale in each questionnaires

  7. Feasibility and acceptability of the study intervention- Adherence rate

    Time frame: From week one to week four, during the intervention period

    The percentage of participants who followed the prescribed interventions as intended

  8. Safety of the intervention- Adverse Events related to the Nurse-led and GP-supported self-management (NGPS) intervention

    Time frame: From week one to week four, during the intervention period

    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

  9. Acceptability of the intervention

    Time frame: At eight-week follow up

    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.

Secondary outcomes

  1. Physiological outcomes- BMI

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    Measuring weight in kilograms, height in centimeters and height and weight will be combined to report BMI in kg/m^2.

  2. Physiological outcomes-blood pressure

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    Measuring blood pressure in millimeters of mercury.

  3. Physiological outcomes-heart rate

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    Measuring heart rate in beats per minute.

  4. Behavioural outcomes using 15-item food frequency questionnaire

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  5. Behavioural outcomes- Self-reported smoking status

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  6. Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  7. Psychological outcome-Self efficacy

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  8. Psychological outcomes-Quality of Life

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  9. Psychological outcome-Anxiety and Depression

    Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

    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.

  10. Healthcare usage

    Time frame: From week one to week four, during the intervention period and at eight week follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anu Correya, Masters

CONTACT

[email protected]

0431659039

Sponsors and collaborators

Lead sponsor

University of Southern Queensland

Other

Registry information

Official study title

Nurse-led and GP-supported Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors With Cardiovascular Diseases

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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