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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Self-management Interventions

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Self-management intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Baseline Information

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

Time frame
Once at baseline
2

Feasibility of recruitment

Number of weeks/months needed to reach target sample size

Time frame
From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months
3

Recruitment rate

The percentage of eligible (or approached) participants who actually agree to take part in the study.

Time frame
Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).
4

Retention rate

The percentage of participants who remain in the study

Time frame
Across the entire trial period, from enrolment to eight weeks post study follow-up

Secondary outcomes

1

Physiological outcomes- BMI

Measuring weight in kilograms, height in centimeters and height and weight will be combined to report BMI in kg/m\^2.

Time frame
At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
2

Physiological outcomes-blood pressure

Measuring blood pressure in millimeters of mercury.

Time frame
At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
3

Physiological outcomes-heart rate

Measuring heart rate in beats per minute.

Time frame
At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
4

Behavioural outcomes using 15-item food frequency questionnaire

Behavioural outcome-dietary outcome Dietary outcomes: dietary intake will be measured by using a 15-item Food Frequency Questionnaire. This food frequency questionnaire is widely used in cardiac patients to screen for poor dietary patterns and has an overall good agreement with the diet history. This has been tested in female patients. The dietary intake was captured using frequency-based units with participants reporting their usual consumption of key food groups. The participants will be asked to mark each component on the 15-item food frequency questionnaire to best reflect their dietary pattern based on the scoring system on the scale. During analysis, a summary diet quality score will be calculated, with higher scores indicating better outcomes and healthier dietary patterns.

Time frame
At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)

Other outcomes

Sponsors and contacts

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