None listed
Conditions
Brief summary
This study is being undertaken to understand the feasibility of generating clinically meaningful patient reported outcome measures using app-based approaches in a population of HR+, HER2– advanced or metastatic breast cancer patients. As well as for assessing virtual decentralised approaches for recruitment. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with HR+, HER2– advanced or metastatic breast cancer, you have recently started taking palbociclib as a treatment for your cancer and you are able to use a smartphone or other compatible device for the duration of the study. Study details All participants who choose to enroll in this study will be directed to download the Pippa study app (aka ClaimIt) to their smartphone or other compatible device, where participants can consent if they want to take part of the study. Immediately after enrolment, participants will be asked to provide demographic and clinical information related to breast cancer. Participants will then be asked to complete three questionnaires about their treatment regime and their health and abilities using the study app, at 1 month, 3 months, 6 months, 9 months and 12 months post-recruitment. It is anticipated that it will take 10-15 minutes for participants to enter these details at each timepoint. Participants may also be asked to complete a survey about their experience using the app at the completion of the study, or if they withdraw from the study at an earlier time. It is hoped this research will determine whether it is practical and acceptable to collect patient health-related information via a specially designed app. If the app is found to be useful, it may be made available on a larger scale so that all breast cancer patients can report their health status regularly and without needing to attend face-to-face appointments.
Interventions
The study is a prospective and multicenter study of patients who have recently initiated on Palbociclib for HR+, HER2– Advanced Breast Cancer in Australia. 149 – 199 patients will be recruited into the study through a “hybrid” approach with 50 – 100 patients recruited through site based channels and 99 patients through virtual channels.
All participants are going to be observed for 12 months, recruitment is expected to take 10 months.
Patients will either be recruited by their treating doct
The study is a prospective and multicenter study of patients who have recently initiated on Palbociclib for HR+, HER2– Advanced Breast Cancer in Australia. 149 – 199 patients will be recruited into the study through a “hybrid” approach with 50 – 100 patients recruited through site based channels and 99 patients through virtual channels. All participants are going to be observed for 12 months, recruitment is expected to take 10 months. Patients will either be recruited by their treating doctor (a.k.a. site-based cohort) or through social media or other virtual channels via an online screening (a.k.a virtual cohort). This study is being completed using a mobile phone-based app. Participants will be sent an email with instructions on how to download a mobile phone-based app called ‘ClaimIt’ as well as their unique study number. Their email address will be kept separate from their study information. Before participating in this study, participants will be asked to give their consent to by clicking on the agree button at the end of the electronic document. Participants will be given the option to send the consent to their email address and can access it at any time on the app. Participants will be asked to complete questionnaires about their health and how they feel upon commencement of the study and again at month 1, month 3, month 6, month 9 and month 12. At each timepoint, the data collection should take no more than 10 - 15 minutes to complete. Data will be collected through a set of questionnaires that they would complete through the mobile phone app; these questionnaires will include: • Baseline questionnaire (at commencement only) – demographics (age, gender, ethnicity, family status), medical history and clinical characteristics, and treatment information. • SF-12 Health Survey – a measure of quality of life. Completed at commencement, month 1, 3, 6, 9 and 12. • Cancer Care Ontario Edmonton Symptom Assessment System revised version (ESAS) – a measure of the intensity of symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness appetite, wellbeing, and shortness of breath. Completed at commencement, month 1, 3, 6, 9 and 12. • Functional Assessment of Cancer Therapy - Breast (FACT-B) – a measure of quality of life by assessing physical, social, emotional, and functional well-being. Completed at commencement, month 1, 3, 6, 9 and 12. • Whether participants had any dosing changes or interruptions. Completed at month 1, 3, 6, 9 and 12. • A brief 5-question- experience survey will be issued at month 12 to gather information regarding overall experience in using the app Participants will receive reminders by email and app notifications on their smartphone when these tasks would need to be completed. If they miss one of their tasks we will enquire as to the reason they missed the latest study activities to understand potential barriers in using these approaches This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids bias from study doctors or participants. There are no costs associated with participating in this research project, nor will participants be paid. For the site-based cohort in addition the treating doctor (investigator) will also gather the following information: • A questionnaire at baseline about demographics (age, gender, ethnicity, family status), medical history and clinical characteristics, and treatment information. Collected at commencement only. • Whether the participant had any dosing changes or interruptions. Collected at month 1, 3, 6, 9 and 12. Patients recruited through the site based approach will be identified by participating investigators and subsequently referred to the study platform within seven days of palbociclib initiation for eligibility screening and electronic informed consent form (eICF). Investigators or trained site personnel will then complete an electronic case report form (eCRF) to capture baseline patient demographics, medical history and clinical characteristics, and treatment information at enrollment. Patients initiated onto palbociclib within the last 90 days will be recruited via virtual channels and will be identified through: 1. Targetted study advertisements placed on social media based on a user’s browing history 2. Partnerships with relevant patient associations (e.g., McGrath Foundation, BCNA) who will share study advertisements to patients through their network Patients enrolling into the study through virtual channels will be screened to ensure eligibility for the study and subsequently referred to the electronic informed consent form (eICF). Screening for the virtual cohort will be a two stage process where patients following an initial study advertisement for patients with breast cancer will be directed to a study landing page that will assess study eligibility (e.g. treatment received for breast cancer, time since initiation, etc.). Patients meeting the study eligibility criteria will then enter their email address which will be used generate a study identification and invitation email. Patients will then be asked to download the app and complete the eICF Only patients enrolling in the site-based cohort will be asked to complete a questionnaire at palbociclib initiation. Both patients enrolling through virtual channels and patients referred by a HCP will be asked to enter their date of palbociclib initiation which will be used to generate subsequent questionnaires for PROs collection at 1 month, 3 months, 6 months, 9 months and 12 months post palbociclib initiation. Treatment related information (i.e. dosing, interruptions) will also be assessed at these timepoints for both cohorts. Qualitative information on study participation will be assessed upon study completion or drop-out.
Sponsors
Pfizer Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has regular access to the ClaimIt virtual trial platform application via Apple iPhone (compatible with operating system versions 13, 12 and 11) or Android phone (compatible with versions 10, 9, 8) and is willing and able to complete data entry through application 2. Adult women or men (greater or equal to 18 years of age) with diagnosis with advanced or metastatic breast cancer not amenable to resection or radiation therapy with curative intent 3. Evidence of HR+ tumor based on the patient’s most recent tumor biopsy as reported by site-based HCP or self-reported by patient 4. Evidence of an HER2– tumor based on the patient’s most recent tumor biopsy as reported by site-based HCP or self-reported by patient 5. Recently intiated on first or second line treatment with one of the following regimens: (i) palbociclib and an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced or metastatic disease as per product label or (ii) palbociclib with fulvestrant if the patient has experienced disease progression following endocrine therapy as per product label, where recently initiaited is defined as within the last seven days for the site based cohort and last 90 days for the virtual cohort 6. Evidence of an electronically signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the study 7. Able to read and understand English
Exclusion criteria
1. Patient has initiated palbociclib more than seven days prior to study or enrolment (site-based cohort) 2. Patient has initiated palbociclib more than 90 days prior to study enrolment (virtual cohort) 3. Patient is initiating adjuvant or neoadjuvant systemic therapy 4. The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study 5. The patient is on active treatment for other malignancies other than Advanced Breast Cancer (ABC) or metastatic breast cancer (mBC) 6. In the judgment of the investigator, the patient’s life expectancy is fewer than 180 days (i.e. six months) at the time of diagnosis of ABC or mBC (site-based cohort)
Outcome results
None listed