|- candidate number||26849|
|- NTR Number||NTR6475|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mrt-2017|
|- Secondary IDs||NL60151.031.16 P160MF Antoni van Leeuwenhoek|
|- Public Title||A tailored physical therapy program for patients with metastatic breast cancer|
|- Scientific Title||Evaluating the feasibility of a tailored physical therapy program for patients with metastatic breast cancer|
|- hypothesis||The objective of the study is to investigate the feasibility of a tailored physical therapy program for metastatic breast cancer patients.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Metastasis|
|- Inclusion criteria||- Aged 18 years and older |
- Histologically confirmed primary or secondary metastatic breast cancer (M1).
- WHO performance score ¡Ü2
- Basic proficiency in the Dutch language
- Approval of the treating physician
- Signed informed consent
- Having 1) self-reported functional problems with activities of daily living or 2) being on active chemotherapy, and a desire to participate in a physical exercise program aimed at reducing or resolving those problems or staying fit, respectively.
- Insured for physiotherapy treatment.
- Both women and men meeting the above criteria are eligible for the study.
|- Exclusion criteria||- Significant cognitive impairment that would preclude the patient from completing questionnaires or following instructions in the intervention.|
- Symptomatic heart disease, including congestive heart failure, arrhythmia, or myocardial infarction diagnosed within the last 3 months.
- Not living in the greater Amsterdam area (due to the geographic boundaries of the network of physical therapy practices linked to the intervention).
- Patients with complex and/or multi-morbid conditions requiring multidisciplinary rehabilitation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||13-mrt-2017|
|- planned closingdate|
|- Target number of participants||40|
|- Interventions||After a comprehensive intake, a tailored physical therapy program will be provided that consists of elements specifically designed for this population that best target the patients goal(s) related to physical activity and staying fit in order to carry out normal activities of daily living. Dependent on the nature of this tailoring, the program content may differ from patient to patient and may range from specific resistance (e.g. leg press) and/or aerobic (e.g. cycling) exercises, functional exercises (e.g. stair climbing), or relaxation exercises (e.g. progressive muscle relaxation). The combination of exercises can be provided either in person or (partly) via an eHealth platform (Physitrack).|
|- Primary outcome||To investigate the feasibility of a tailored exercise and/or relaxation intervention for metastatic breast cancer survivors primarily in terms of uptake, safety, adherence, , and goal attainment. Secondary aspects are adherence, and patient and provider satisfaction.|
|- Secondary outcome||To generate preliminary information on the impact of the tailored intervention in terms of maintenance or improvement of physical fitness, physical functioning, fatigue and quality of life. The specific outcomes of interest will vary from patient to patient as a function of her their specific goals.|
|- Timepoints||At baseline, and after end of intervention (6-12 weeks later)|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. Wim Groen |
|- CONTACT for SCIENTIFIC QUERIES||Dr. Wim Groen |
|- Sponsor/Initiator ||Antoni van Leeuwenhoek |
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||9-mrt-2017 - 5-jul-2017|