Breast CancerNCT07313397
Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors
A study testing Self-management Interventions in people with Breast Cancer, run by University of Southern Queensland at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Self-management Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesAustralia
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
Greens Medical Group, Dandenong South
Melbourne, Victoria, 3173
Riekie Joose, 0390878351, pm@greensmedicalgroup.com.au
Keys Medical Centre, Keysborough
Melbourne, Victoria, 3173
Riekie Jooste, 0390878351, pm@greensmedicalgroup.com.au
TLC Medical Clinic, Noble Park
Melbourne, Victoria, 3173
Mayuriben Prasad, (03) 9548 0868, tlcmedicalclinic1a@gmail.com
About this study
Official title: Nurse-led and GP-supported Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors With Cardiovascular Diseases
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))?
- Conditions
- Breast Cancer
- Being tested
- Self-management Interventions
- Keywords
- Breast Cancer, Cardiovascular disease, Self-management Interventions, Breast Cancer Suvivors
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management InterventionsOther
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 group | Role | What they receive |
|---|---|---|
| Self-management intervention group | Experimental | 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. Receives: Other: Self-management Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once at baseline
Feasibility of recruitment
Number of weeks/months needed to reach target sample size
Measured: From recruitment start (Day 1 of the recruitment) to recruitment close (the day that the target sample reached), up to 12 months
Recruitment rate
The percentage of eligible (or approached) participants who actually agree to take part in the study.
Measured: Recruitment rate will be assessed monthly over the recruitment period (up to 12 months).
Retention rate
The percentage of participants who remain in the study
Measured: Across the entire trial period, from enrolment to eight weeks post study follow-up
Dropout rate
The percentage of participants dropped out after the study enrolment
Measured: Across the entire trial period, from enrolment to eight weeks post study follow-up
Feasibility of the questionnaires
The percentage of missing responses for each item and the entire scale in each questionnaires
Measured: Across the entire trial period, from enrolment to eight weeks post study follow-up
Feasibility and acceptability of the study intervention- Adherence rate
The percentage of participants who followed the prescribed interventions as intended
Measured: 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
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
Measured: From week one to week four, during the intervention period
Acceptability of the intervention
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.
Measured: At eight-week follow up
Secondary outcomes (10)
Physiological outcomes- BMI
Measuring weight in kilograms, height in centimeters and height and weight will be combined to report BMI in kg/m^2.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-blood pressure
Measuring blood pressure in millimeters of mercury.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-heart rate
Measuring heart rate in beats per minute.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
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.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes- Self-reported smoking status
Behavioural outcome- smoking status Self-reported smoking status. Participants will be asked to report their smoking status by selecting one option that best describes them. The numeric values will be 0, 1 and 2. O indicates never smoked (have never smoked cigarettes or tobacco products), 1 indicates former smoker (previously smoked but does not currently smoke), and 2 indicates current smoker (currently smoke cogarettes or tobacco products). The minimum value will be 0, and the maximum value will be 2. Higher scores indicate a poor outcome or greater current exposure to smoking.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire
Behavioural outcome-Physical activity Physical activity: it will be measured by using the International Physical Activity Questionnaire (IPAQ). This IPAQ is a well-validated tool in Australian adults and has good reliability and validity for assessing physical activity in breast cancer survivors. IPAQ data will be collected minutes per day or hours per day and converted to MET-minutes per week for analysis. Responses will be scored and classified according to established IPAQ scoring guidelines into one numeric value of 1-3 based on reported frequency, duration, and intensity of physical activity. The numeric value of 1 indicates low physical activity, 2 indicates moderate physical activity, and 3 indicates high physical activity. The minimum value is 1, and the maximum value is 3. Higher scores indicate better outcomes or greater levels of physical activity.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Self efficacy
Psychological outcome:
Self-efficacy: It will be measured by using the General Self-Efficacy Scale (GSES). This 10-item scale will measure patients' beliefs in their ability to cope with various challenging situations. GSES demonstrated high reliability and validity across a range of populations. The GSES uses a 4-point Likert response scale yielding a total score ranging from 10 to 40, with higher score indicating greater self efficacy.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcomes-Quality of Life
Psychological outcome:
Quality of life (QoL): It will be measured by using the Functional Assessment of Cancer Therapy-Breast (FACT-B). This is a targeted QoL measurement tool for breast cancer patients with satisfactory reliability and validity. This tool will assess physical well-being, social well-being, emotional well-being and functional well-being, as well as 10 items for additional concerns. The FACT-B uses a 5-point Likert response scale (0-4)across its subscales, with the summed score representing breast cancer specific QoL.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Anxiety and Depression
Psychological outcome:
Anxiety and depression: They will be measured by using the well-established 14-item Hospital Anxiety and Depression Scale (HADS). HADS is a widely adopted tool in various populations, including cancer patients and primary healthcare settings. The HADS uses a 4-point Likert scoring system (0-3), yielding subscale scores from 0-21 for anxiety and depression.
Measured: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Healthcare usage
When a participant uses health services related to the cardiovascular conditions such as hospital visits and GP visits will be recorded using an investigator created logbook.
Measured: From week one to week four, during the intervention period and at eight week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anu Correya, University of Southern Queensland
- Investigators
- Alison Wang, PhD, Principal investigator, University of Southern Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313397
- Sponsor's protocol ID
- ETH2025-0291
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led and GP-supported Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors With Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07313397
- Acronym / sponsor ID
- ETH2025-0291
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cardiovascular disease, Self-management Interventions, Breast Cancer Suvivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Southern QueenslandUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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))?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-management intervention group | Experimental | Other: Self-management InterventionsA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management InterventionsSelf-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. | Other | Self-management intervention group |
Primary outcome
Baseline Information
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Physiological outcomes- BMI
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-blood pressure
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Physiological outcomes-heart rate
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes using 15-item food frequency questionnaire
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes- Self-reported smoking status
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Behavioural outcomes-Physical activity assessment using the International Physical Activity Questionnaire
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Self efficacy
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcomes-Quality of Life
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Psychological outcome-Anxiety and Depression
Time frame: At baseline (T1), immediately post intervention (T2), and eight-week follow-up (T3)
Healthcare usage
Time frame: From week one to week four, during the intervention period and at eight week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison Wang, PhD principal investigator
University of Southern Queensland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management Interventions in people with Breast Cancer, run by University of Southern Queensland at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anu Correya, Masters (0431659039, anu.correya@unisq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Information (time frame: Once at baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.