Implementing Patients´ Competence in Oral Breast Cancer Therapy (IMPACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04030728|
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
|Condition or disease|
|Metastatic Breast Cancer Advanced Breast Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||212 participants|
|Official Title:||A Randomized, Controlled Study of Standardized Patient Coaching Versus Patient Management According to Local Practice for Patients With Hormone Receptor Positive HER2 Negative Metastatic Breast Cancer Treated With Abemaciclib|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Group 1: Standardized coaching arm
Patients in this group receive a continuous standardized MOATT based patient education and coaching and optional eMBSR (electronic Mindfulness-Based Stress Reduction) within the first 24 weeks of Abemaciclib treatment.
Group 2: Coaching according to local practice
Patients in this group receive a patient management according local routine.
- (Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms. [ Time Frame: 24 weeks ]The primary objective of this study is to evaluate both study arms regarding the (potential) effect of patient management according to local routine versus continuous standardized patient education and coaching using the MOATT on persistence rate within the first 24 weeks of Abemaciclib treatment.
- Patient decided interruptions [ Time Frame: 24 weeks ]Total time of patient decided interruptions in days during 24 weeks of Abemaciclib therapy in both study arms.
- eMSBR [ Time Frame: 24 weeks ]The effect of eMSBR after 24 weeks of Abemaciclib therapy.
- Quality of life assessed by the FACT-B (Version 4.0) questionnaires. [ Time Frame: 24 weeks ]After weeks 2, 6, 12, 18 and 24, quality of Life (QoL) will be assessed by the FACT-B (Version 4.0) questionnaires.
- Patient distress assessed via distress thermometer. [ Time Frame: 24 weeks ]After weeks 2, 6, 12, 18 and 24, patient distress will be assessed via distress thermometer.
- To assess patient reported self-efficacy: patient diary [ Time Frame: 24 weeks ]Self-efficacy will be patient reported and surveyed through a patient dairy.
- To assess patient reported side-effects. [ Time Frame: 24 weeks ]Type and duration of side-effects will be patient reported and surveyed through a patient dairy.
- To assess patient reported health related stress. [ Time Frame: 24 weeks ]Health related stress will be patient reported and surveyed via distress thermometer questionnaire.
- To assess patient reported therapy related knowledge. [ Time Frame: 24 weeks ]Therapy related knowledge will be surveyed via MOATT (MASCC Oral Agent Teaching Tool).
- Incidence of therapy interruptions. [ Time Frame: 24 weeks ]Amount of relevant events will be surveyed through patient self-reporting via patient diary.
- Duration of therapy interruptions. [ Time Frame: 24 weeks ]Relevant events (in days) will be surveyed through patient self-reporting via patient diary.
- Safety and tolerability of Abemaciclib treatment: NCI Common Toxicity Criteria Version 5.0 [ Time Frame: 24 weeks ]Incidence of adverse events and serious adverse events will be reported according to NCI Common Toxicity Criteria Version 5.0.
- Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Progression free survival rate (PFS). [ Time Frame: 24 weeks ]Progression free survival (PFS) rate at 24 weeks of therapy. PFS is defined as time interval from start of therapy until progressive proven with clinical measures according to expertise and daily clinical routine or death from any cause, whichever comes first.
- Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Overall survival rate (OS). [ Time Frame: 24 weeks ]Overall survival (OS) rate at 24 months is defined as the time to death from therapy start of Abemaciclib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030728
|Contact: Jenny Palmrich||0049 69 560056 firstname.lastname@example.org|
|Contact: Oliver Knapp, PhD||0049 931 359200 email@example.com|
|Principal Investigator:||Hans Tesch, Prof. Dr. med.||Onkologie Bethanien Frankfurt|
|Principal Investigator:||Manfred Welslau, Dr. med.||Onkologie Aschaffenburg|