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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Self-management Interventions

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anu Correya, Masters; Phone Number: 0431659039; Email: anu.correya@unisq.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3173
      • Greens Medical Group, Dandenong South
      • Contact: Riekie Joose; Phone Number: 0390878351; Email: pm@greensmedicalgroup.com.au
    • Melbourne, Victoria, Australia, 3173
      • Keys Medical Centre, Keysborough
      • Contact: Riekie Jooste; Phone Number: 0390878351; Email: pm@greensmedicalgroup.com.au
    • Melbourne, Victoria, Australia, 3173
      • TLC Medical Clinic, Noble Park
      • Contact: Mayuriben Prasad; Phone Number: (03) 9548 0868; Email: tlcmedicalclinic1a@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Self-management intervention group; A combined face-to-face and telehealth self-management intervention will be conducted over four weeks, following assessment of the patients' cardiac condition, breast cancer, health literacy, and access to resources. The interventions will be carried out mainly by nurses, GPs, and allied health professionals, who will be included if needed. Patients and caregivers will be involved in the sessions. The self-management interventions will be behaviour change interventions, such as physical exercise, dietary modifications, smoking cessation and weight management.

Other: Self-management Interventions; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Once at baseline
Feasibility of recruitment	Number of weeks/months needed to reach target sample size	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.	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	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	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	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	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	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.	At eight-week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological outcomes- BMI	Measuring weight in kilograms, height in centimeters and height and weight will be combined to report BMI in kg/m^2.	At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-blood pressure	Measuring blood pressure in millimeters of mercury.	At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-heart rate	Measuring heart rate in beats per minute.	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.	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.	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.	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.	From week one to week four, during the intervention period and at eight week follow-up
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.	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.	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.	At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

Collaborators and Investigators

• Sponsor: University of Southern Queensland
• Investigators: Principal Investigator: Alison Wang, PhD, University of Southern Queensland

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Breast Cancer; Self-management Interventions; Breast Cancer Suvivors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Cardiovascular Diseases; Breast Neoplasms
• Other Study ID Numbers: ETH2025-0291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No