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

University of Southern Queensland

Status: Begins enrollment this month

Conditions: Breast Cancer

Treatments: Other: Self-management Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT07313397

ETH2025-0291

Details and patient eligibility

About

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))?

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Self-management intervention group

Experimental group

Description:

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.

Treatment:

Other: Self-management Interventions