Investigate the consequences of axillary lymph node dissection (ALND) and sentinel lymph node procedure (SNP) regarding shoulder impairments, the activities a women still undertakes and the role of quality of life and anxiety in this in women who…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- type of surgery
- physical complaints: pain, lymph edema, loss of strength, limitations (in
daily life)
- shoulder impairments (abduction, endo/exorotation, ventral/dorsal elevation)
and arm circumference
- quality of life, health status
- state anxiety and trait anxiety
Secondary outcome
- number of surgeries
- tumor lokalization/side/size
- number of positive lymph nodes
- complications after surgery
- adjuvant treatment
- medication
Background summary
Breast cancer is the most common form of cancer in women. There are two types
of surgery: breast conserving therapy and mastectomy. Also the axillary lymph
nodes will be examined (sentinel lymph node procedure, SNP). When these nodes
contain tumor cells, an axillary lymph node dissection (ALND) will be
performed. This procedure is preferred in early stage breast cancer, because
often there are no metastasis and it is associated with a faster recovery and a
shorter hospital stay than the ALND. Besides, an ALND can be first choice
(especially when there are suspicious palpable axillary lymph nodes), in which
all axillary lymph nodes will be removed. Both procedures can lead to range of
motion limitations in the arm. Patients who underwent an ALND, often have more
pain, experience more sensory disorders, have more often lymph edema, have
limitations of shoulder function and experience less strength at the operated
side. With regard to the health status, women with ALND have more limitations
in daily life and, within one year after surgery, they have less improvement of
function than the patients who only underwent SNP. Recently, a randomized multi
center trial found that SNP is preferred over ALND in women with early stage
breast cancer, because of the decreased arm morbidity and a better quality of
life after 12 months of follow-up. At the same time physiotherapy after ALND
has a favorable effect on shoulder and arm complaints and on quality of life
compared to conservative treatment (explanation and advice). However, it is
unknown which limitations women rightly of wrongly lay upon themselves in doing
all sorts of activities. Furthermore, there is little known about the long term
consequences of both procedures.
Study objective
Investigate the consequences of axillary lymph node dissection (ALND) and
sentinel lymph node procedure (SNP) regarding shoulder impairments, the
activities a women still undertakes and the role of quality of life and anxiety
in this in women who had an SNP and/or ALND at least 6 months till almost 7
years ago. Also, investigate whether some patients may need extra counseling
and information to better deal with their disease.
Study design
clinical, involving patients
Study burden and risks
- one visit to the investigator (length 45 minutes)
- filling in four or five questionnaires (quality of life, health status,
measuring anxiety, physical complaints)
- physical examination: measuring function of both shoulder-joints, measuring
arm circumference
Lange Nieuwstraat 191-32
5041 DB
Nederland
Lange Nieuwstraat 191-32
5041 DB
Nederland
Listed location countries
Age
Inclusion criteria
- All women from january 2002 till may 2008 in St. Elisabeth Hospital (Tilburg, Netherlands) diagnosed with early stage breast cancer who underwent axillary lymph node dissection, sentinel lymph node procedure or both.
Exclusion criteria
- loco-regional recurrence or metastasis
- cognitive impairment
- doesn't speak Dutch
- shoulder impairments, not as a consequence of breast cancer
Design
Recruitment
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 | NL24275.008.08 |