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

Официальное название

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

Обзор

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))?

Вмешательства

• Другое 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.

Первичные конечные точки

• Baseline Information [Срок оценки: Once at baseline]
• Feasibility of recruitment [Срок оценки: From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months]
• Recruitment rate [Срок оценки: Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).]
• Retention rate [Срок оценки: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Dropout rate [Срок оценки: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Feasibility of the questionnaires [Срок оценки: Across the entire trial period, from enrolment to eight weeks post study follow-up]
• Feasibility and acceptability of the study intervention- Adherence rate [Срок оценки: 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 [Срок оценки: From week one to week four, during the intervention period]
• Acceptability of the intervention [Срок оценки: At eight-week follow up]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австралия · 3 центра

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

Идентификаторы

NCT: NCT07313397 · ETH2025-0291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗