Nurse-led and GP-supported Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors With Cardiovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
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:
- 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?
- 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?
- 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))?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Self-management intervention group
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.
干预措施: Self-management Interventions (Other)
结局指标
主要结局
Feasibility of recruitment
时间窗: 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
时间窗: 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.
Dropout rate
时间窗: 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
时间窗: 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
时间窗: From week one to week four, during the intervention period
The percentage of participants who followed the prescribed interventions as intended
Baseline Information
时间窗: 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
Safety of the intervention- Adverse Events related to the Nurse-led and GP-supported self-management (NGPS) intervention
时间窗: 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
时间窗: 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.
Baseline Information
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Physiological outcomes-heart rate(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Behavioural outcomes- Self-reported smoking status(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcome-Self efficacy(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcomes-Quality of Life(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcome-Anxiety and Depression(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Healthcare usage(From week one to week four, during the intervention period and at eight week follow-up)
- Physiological outcomes- BMI(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Physiological outcomes-blood pressure(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Physiological outcomes-heart rate(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Behavioural outcomes using 15-item food frequency questionnaire(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Behavioural outcomes- Self-reported smoking status(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcome-Self efficacy(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcomes-Quality of Life(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Psychological outcome-Anxiety and Depression(At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3))
- Healthcare usage(From week one to week four, during the intervention period and at eight week follow-up)
研究者
Anu Correya
Principal Investigator
University of Southern Queensland