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

NCT07313397 | Not Yet Recruiting

• 1 other identifier: ETH2025-0291
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 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. 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))?

Conditions

Breast Cancer

Keywords

Breast Cancer; Cardiovascular disease; Self-management Interventions; Breast Cancer Suvivors

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (10)

• Physiological outcomes- BMI

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

• Physiological outcomes-blood pressure

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

• Physiological outcomes-heart rate

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

• Behavioural outcomes using 15-item food frequency questionnaire

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

• Behavioural outcomes- Self-reported smoking status

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

Study Arms (1)

Self-management intervention group

EXPERIMENTAL

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

Interventions

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.

Self-management intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female breast cancer survivors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• confirmed diagnosis of breast cancer at stage I, II, or IIIa
• confirmed diagnosis of CVDs, including heart failure, coronary artery disease, stroke, or transient ischemic attack
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Queensland: lead

Study Sites (3)

Greens Medical Group, Dandenong South

Melbourne, Victoria, 3173, Australia

Location

Keys Medical Centre, Keysborough

Melbourne, Victoria, 3173, Australia

Location

TLC Medical Clinic, Noble Park

Melbourne, Victoria, 3173, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alison Wang, PhD

  University of Southern Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anu Correya, Masters

CONTACT

0431659039; anu.correya@unisq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)