None listed
Conditions
Brief summary
Hypothesis It is estimated that >30% of early breast cancer patients who have received systemic adjuvant treatment will experience survivorship issues in the subsequent 5 years following diagnosis. During this period, it may affect physical and psychosocial functioning, with changes to their employment and/or financial status, and the severity and incidence will diminish over time. Aim The aim is to identify how a prior diagnosis of breast cancer and its treatment impacts on physical and psychosocial functioning over time. For this trial, no study specific visit at the clinic is required. Who is it for? In this trial, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors. In addition, some demographic information will be collected. Study details Upon return of signed Participant PICF a delegated BCRC-WA trial staff and PI will review eligibility. The Participant will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaire to complete within 42 days of the consent signature. It is anticipated that this will take them 15-30 minutes overall. The trial data collected will only be analysed after recruitment is complete and all data has been collected. It is clearly stated in the Patient Informed Consent that data is not collected for treatment purpose. The trial recruitment period is planned to last 6-12 months, the expected duration of the project is January 2018 to January 2020. It is anticipated that 200 participants will be recruited.
Interventions
In this study, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors.
All participants will complete the following questionnaires/surveys to evaluate:
a. Demographics
In this study, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors. All participants will complete the following questionnaires/surveys to evaluate: a. Demographics and socioeconomic information via a modified survey based on the Australia Bureau of Statistic Forms of Employment survey b. Mood disturbances: PHQ-9 & GAD-7 c. Quality of life based on prior adjuvant treatment received: Fact-B d. Cognitive functioning: Fact-Cog e. Impact of spirituality: Facit-Sp-12 f. Financial impact: Cost – FACIT g. Fatigue: Facit-F In addition, participants who have received taxane based chemotherapy, endocrine therapy or both will also complete the following quality of life questionnaires, as relevant: h. Taxane based chemotherapy: FACT-Taxane i. Endocrine treatment: FACT-ES Participants sign a consent form to confirm in writing they agree to take part in the study. Upon return of signed PIC, delegated BCRC-WA staff will review eligibility and confirm final eligibility with the PI. Study staff will then obtain demographic information about the participant. Then participants will be asked to complete the questionnaires at home within 42 days of signing consent. It is anticipated that this will take them 15-30 minutes overall. Participants will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaires.
Sponsors
Breast Cancer Research Centre-WA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of written informed consent 2. At least 18 years of age at the time of consent 3. Diagnosis of early (non-metastatic) breast cancer. This includes patients diagnosed with DCIS only, provided they have undergone surgery. 4. Have undergone definitive breast surgery 5. Have completed recommended chemotherapy with or without trastuzumab treatment and/or targeted radiation therapy as part of their adjuvant treatment (patients who did not complete planned treatment as a consequence of intolerable toxicity and/or at the recommendation of the treating breast specialist remain eligible for inclusion). Patients for whom no chemotherapy was recommended are also eligible. 6. Patients must have received their surgical, systemic and/or radiation treatment under the care of a doctor at BCRC-WA 7. Patients who were diagnosed with any psychological disorder prior to or following breast cancer diagnosis are eligible 8. Clinically assessed as disease-free by the treating clinician at the time of study consent 9. Commits to completing all questionnaires online within 42 days of consent. This is estimated to take up to 30 minutes, which does not need to be done at one time point.
Exclusion criteria
1. Patients who do not regard Western Australia as their state of residence. 2. Patients who work and live outside Western Australia > 6 months of the year. 3. Patients who are unable to read and understand English 4. Patients who have declined part or all recommended breast cancer treatment against medical advice.
Outcome results
None listed