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

Official title

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

Overview

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))?

Interventions

• 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.

Primary outcome measures

• Baseline Information [Time frame: Once at baseline]
• 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]
• Recruitment rate [Time frame: Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).]
• Retention rate [Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Dropout rate [Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Feasibility of the questionnaires [Time frame: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Feasibility and acceptability of the study intervention- Adherence rate [Time frame: 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 [Time frame: From week one to week four, during the intervention period]
• Acceptability of the intervention [Time frame: At eight-week follow up]

Secondary outcome measures (10)

• Physiological outcomes- BMI [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Physiological outcomes-blood pressure [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Physiological outcomes-heart rate [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Behavioural outcomes using 15-item food frequency questionnaire [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Behavioural outcomes- Self-reported smoking status [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• 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)]
• Psychological outcome-Self efficacy [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Psychological outcomes-Quality of Life [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Psychological outcome-Anxiety and Depression [Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)]
• Healthcare usage [Time frame: From week one to week four, during the intervention period and at eight week follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Australia · 3 centers

• Greens Medical Group, Dandenong South — Melbourne
• Keys Medical Centre, Keysborough — Melbourne
• TLC Medical Clinic, Noble Park — Melbourne

Identifiers

NCT: NCT07313397 · ETH2025-0291

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗