The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC). This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy.
Study Type
OBSERVATIONAL
Enrollment
100
Health Centre Loznica
Loznica, Bolnička 65, Serbia
RECRUITINGGeneral Hospital Požarevac
Požarevac, Bratstva Jedinstva 135, Serbia
RECRUITINGHealthcare Centre Bor
Bor, Dragiše Mišovića 1, Serbia
RECRUITINGHealth Centre Kladovo
Kladovo, Dunavska 1-3, Serbia
RECRUITINGHealth Centre ''Sveti Luka'' Smederevo
Smederevo, Knez Mihailova 51, Serbia
RECRUITINGGeneral Hospital Pančevo
Pančevo, Miloša Trebinjca 11, Serbia
RECRUITINGInstitute for Onocology and Radiology of Serbia
Belgrade, Pasterova 14, Serbia
RECRUITINGGeneral Hospital "Dr Laza K. Lazarevic" Sabac
Šabac, Popa Karana 2-4, Serbia
RECRUITINGHealth Centre Valjevo
Valjevo, Sinđelićeva 62, Serbia
RECRUITINGGeneral Hospital ''Stefan Visoki'' Smederevska Palanka
Smederevska Palanka, Vuka Karadžića 147, Serbia
RECRUITINGTreatment Adherence Rate
Time frame: Up to 2.25 years
Treatment Completion Rate for Anti-HER2 Treatment
Time frame: Up to 2.25 years
Percentage of Participants With ≥1 Dose Delays Exceeding a Pre-defined Threshold (3 Weeks) From the Scheduled Date
Time frame: Up to 2.25 years
Mean Travel Burden Between Group 1 (Cohorts A, C, D) and Group 2 (Cohort B) During the Adjuvant Therapy Phase
Travel Burden is a composite measure encompassing both objective and subjective components. Objective travel burden is defined by the one-way travel distance (in kilometers \[km\]) and one-way travel time (in minutes) from the participant's residence to the treatment center. Subjective travel burden will capture the participant's personal experience and will be assessed using patient-reported outcomes collected via dedicated questionnaires.
Time frame: Up to 2.25 years
Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers
Travel Burden is a composite measure encompassing both objective and subjective metrices. Objective travel metrics include driving distance and travel time and subjective, patient-reported metrics include out-of-pocket costs, mode of transport, and perceived travel-related challenges. Intra-participant travel burden between the Neoadjuvant and Adjuvant treatment centers will be done as a longitudinal analysis of the change in these metrics from the neoadjuvant to the adjuvant phase.
Time frame: Up to 2.25 years
Difference in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score, Between Participants of Cohort B and Cohort C
EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions that evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). The GHS/QoL questions will be scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores will be linearly transformed to a range of 0-100. A high score for a GHS/QoL scale indicates a better health-related quality of life (HRQoL).
Time frame: At 6 months post-baseline
Mean Intra-patient Change in the EORTC QLQ-C30 GHS/QoL Score
EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions that evaluates 5 aspects of participant functioning (physical, emotional, role, cognitive, \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). The GHS/QoL questions will be scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores will be linearly transformed to a range of 0-100. A high score for a GHS/QoL scale indicates a better HRQoL.
Time frame: Cohorts A, B and C: Baseline to Month 6; Cohort D: Month 6 to Month 12
Time to Neoadjuvant Treatment Initiation
Time to Neoadjuvant Treatment Initiation was defined as time from early breast cancer (eBC) diagnosis to the start of neoadjuvant treatment. Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.
Time frame: At Baseline
Time to Surgery
Time to surgery was defined as the time from the neoadjuvant treatment completion to surgery. Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.
Time frame: At Baseline
Time to Adjuvant Treatment Initiation
Time frame: Time from surgery to the start of adjuvant treatment (up to approximately 1.25 years)
Percentage of Participants Treated at Least Once With Neoadjuvant Therapy
Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.
Time frame: At Baseline
Percentage of Participants Not Treated With Neoadjuvant Therapy
Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.
Time frame: At Baseline
Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion
Data for neoadjuvant treatment will be collected retrospectively at the baseline visit using the participant's medical records.
Time frame: At Baseline
Reference Study ID Number: ML46477 https://forpatients.roche.com/
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