Our primary objective is to test the feasibility of a tailored physical therapy program especially designed for metastatic breast cancer patients. As a secondary objective we will evaluate the impact of the program with regard to goal attainment,…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of the tailored physical therapy program in terms of uptake,
safety, and goal attainment. Intervention adherence , and satisfaction of
patients and physical therapists will be assessed for possible improvement of
the intervention.
Secondary outcome
Activities of daily living (User-P questionnaire), and health related quality
of life (EORTC QLQ-C30 questionnaire). Medical data concerning diagnosis,
metastases, treatments and comorbidities will be obtained from the medical
record only after explicit consent of patients.
Background summary
Health care services targeted at enhancing physical fitness and physical
activity for patients with metastatic breast cancer are often fragmented and
standardized rather than tailored to the individual patient. This can result in
suboptimal care.
Study objective
Our primary objective is to test the feasibility of a tailored physical therapy
program especially designed for metastatic breast cancer patients. As a
secondary objective we will evaluate the impact of the program with regard to
goal attainment, and maintenance of or improvement in physical and psychosocial
outcomes relevant to the patients* goals.
Study design
A single group intervention study, with assessments at baseline and after the
intervention program, approximately 6 to 12 weeks after baseline.
Intervention
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).
Study burden and risks
Patients who participate will be asked to complete a series of questionnaires
pre- and post-intervention and may be asked to perform specific
performance-based tests (e.g. 6 minute walk test), when relevant to the goal of
the patient. They will subsequently perform exercises that are tailored to
their specific goals in a specialized physical therapy practice, at home or a
combination of both. All performance-based tests (at the intake) and exercise
and relaxation intervention components are evidence-based to the best possible
extent, and the literature reports no adverse events from these interventions
in patients with metastatic cancer.
plesmanlaan 121
amsterdam 1066cx
NL
plesmanlaan 121
amsterdam 1066cx
NL
Listed location countries
Age
Inclusion criteria
1) metastatic breast cancer; 2) At least 18 years of age; 3) hose WHO performance score of 0-2; 3) Able to read and write Dutch; and 4) having functional problems with activities of daily living.
Exclusion criteria
1) significant cognitive impairment; 2) symptomatic heart disease; 3) live outside of the greater Amsterdam area; 4) have complex and/or multi-morbid conditions requiring multidisciplinary rehabilitation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60151.031.16 |
| OMON | NL-OMON22708 |