To set up a cohort of breast cancer patients, collecting information on patient characteristics, short and long-term clinical and patient reported data, and to compare outcomes with a healthy refrence population. whichThe cohort will also serve as…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters (e.g. co-morbidity, oncological history, symptoms, imaging,
technical and treatment data), clinical endpoints (e.g. toxicity, recurrence,
survival and side effects) and patient reported outcomes (e.g. Quality of Life
(QoL) and cosmetic evaluation).
Secondary outcome
Not applicable.
Background summary
Due to better treatment options and earlier detection, survival rates of
patients with breast cancer continue to increase. As such, (late) treatment
toxicity, (long-term) quality of life and cosmetic outcome are becoming more
important. Also, many competing experimental interventions (e.g. treatment,
lifestyle interventions) for breast cancer are being developed, all in need to
be properly evaluated before being implemented in routine clinical care.
Randomized Controlled Trials are the gold standard to do so, but they have
shown many challenges, especially when applied in a cancer setting. The *cohort
multiple Randomized Controlled Trial (cmRCT)* design is a promising design for
multiple (simultaneous) randomized evaluations of experimental interventions,
with potential for increased recruitment, comparability and long-term outcomes
as a standard.
Study objective
To set up a cohort of breast cancer patients, collecting information on patient
characteristics, short and long-term clinical and patient reported data, and to
compare outcomes with a healthy refrence population. whichThe cohort will also
serve as an infrastructure for efficient, fast and pragmatic randomized
evaluation of innovative interventions.
Study design
Observational, prospective cohort study, according to the *cohort multiple
Randomised Controlled Trial* (cmRCT) design.
Study burden and risks
Patients will not experience direct benefit from participation in the UMBRELLA
cohort. By participating, patients will contribute to the evidence on clinical
and environmental factors associated with treatment outcome, QoL and survival.
This will lead to better and a more personalized cancer care for future
patients. Risks associated with participating in the UMBRELLA cohort study are
negligible since it is an observational study. Filling out the questionnaires
is the only burden for the patients participating in this cohort. It will take
approximately 20 minutes to fill out the questionnaires each time.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years;
- Patients with breast cancer who undergo treatment in or are referred to the
hospital;
- Informed consent - at least - for use of routinely collected clinical data.
Exclusion criteria
- Mentally incompetent patients;
- Inability to understand the Dutch language.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52651.041.15 |