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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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. 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

Primary outcome measure(s)

• Baseline Information — Once at baseline
  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
• Feasibility of recruitment — From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months
  Number of weeks/months needed to reach target sample size
• Recruitment rate — Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).
  The percentage of eligible (or approached) participants who actually agree to take part in the study.
• Retention rate — Across the entire trial period, from enrolment to eight weeks post study follow-up
  The percentage of participants who remain in the study
• Dropout rate — Across the entire trial period, from enrolment to eight weeks post study follow-up
  The percentage of participants dropped out after the study enrolment
• Feasibility of the questionnaires — Across the entire trial period, from enrolment to eight weeks post study follow-up
  The percentage of missing responses for each item and the entire scale in each questionnaires
• Feasibility and acceptability of the study intervention- Adherence rate — From week one to week four, during the intervention period
  The percentage of participants who followed the prescribed interventions as intended
• Safety of the intervention- Adverse Events related to the Nurse-led and GP-supported self-management (NGPS) intervention — From week one to week four, during the intervention period
  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
• Acceptability of the intervention — At eight-week follow up
  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.

Trial sites (3)

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