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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Southern Queensland

About this trial

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))?

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Self-management Interventions

Treatment groups

15 Participants
are divided into 1 treatment group