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

NCT ID: NCT07313397

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-02-28

Brief Summary

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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))?

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Self-management Interventions

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Queensland

OTHER

Sponsor Role lead

Responsible Party

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Anu Correya

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Queensland

Locations

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Greens Medical Group, Dandenong South

Melbourne, Victoria, Australia

Site Status

Keys Medical Centre, Keysborough

Melbourne, Victoria, Australia

Site Status

TLC Medical Clinic, Noble Park

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Central Contacts

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Anu Correya, Masters

Role: CONTACT

0431659039

Facility Contacts

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Riekie Joose

Role: primary

0390878351

Riekie Jooste

Role: primary

0390878351

Mayuriben Prasad

Role: primary

(03) 9548 0868

Other Identifiers

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ETH2025-0291

Identifier Type: -

Identifier Source: org_study_id

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