Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04059835 |
| Other study ID # |
KarolinskaUD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2019 |
| Est. completion date |
May 30, 2020 |
Study information
| Verified date |
August 2019 |
| Source |
Karolinska University Hospital |
| Contact |
Backman |
| Phone |
+46739167393 |
| Email |
malin.backman[@]sll.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study evaluates how two different types of postoperative bra 1) standard bra, soft VS 2)
compression bra compression after breast cancer surgery affect pain, seroma, other symptoms
and complications, and the womans experience of comfort
Description:
Background
Breast cancer is the most common form of cancer in women and in Sweden about 9700 women are
affected each year.Therefore, it is of great importance to promote the rehabilitation process
by minimizing unnecessary symptoms and complications that may arise during a breast cancer
treatment. Surgery is the primary cure for breast cancer and about 40% need to undergo a
major surgical procedur and major operations also involve an increased risk of complications
and symptoms.
Pain is the most common reported symptom in women who are operated on for breast cancer other
complications after surgery that may occur are seroma, wound infektions and swelling.
No published evidence exists for the benefit and effect in pain relief from wearing a bra as
a support after breast surgery is available, therefore it is important to evaluate useful and
simple methods that the patient can manage herself that can minimize the experience of pain
and other symptom after breast cancer surgery.
At Karolinska University Hospital's breast cancer center, women who undergo breast surgery
are offered a bra after surgery in order to provide good support for the patient to feel
safe, comfortable and minimize complications and symptoms such as pain. Two different types
of bra are used and, according to the clinical staff at Karolinska's breast cancer center
clinical experience, there is disagreement about which type of bra gives the optimal effect
in different surgical procedures to reduce symptoms and post-operative complications. Neither
is there enough knowledge about and how women experience comfort from the bra they received
from the healthcare, which is important as the bra should be used large parts of the day for
about 3 weeks after the procedure. Lack of knowledge makes it difficult to provide
person-centered care for each individual. The purpose of this study is to compare two
different types of bra after breast cancer surgery and to evaluate whether a particular type
of bra affects the perception of pain, other symptoms, the occurrence of complications and
experiences of bra comfort.
Purpose
To compare two different types of postoperative-bra after breast cancer surgery and to
evaluate how a particular type of bra affects the perception of pain, other symptoms, the
occurrence of complications and comfort.
Outcome Measure
The primary outcome measure is the presence of pain. Secondary outcome measures are, other
symptoms, seroma, wound complications, and the patient's experience of satisfaction with
support and comfort when using their postoperative bra.
Design
Randomized controlled trial aimed to comparing two groups of women undergoing breast cancer
surgery.
Participant
Women diagnosed with breast cancer and undergoing breast surgery.
Data Collection
The data collection will take place at the Breast Center, Karolinska University Hospital in
Solna, where approximately 500 breast cancer operations are performed every year. The women
will be identified by the nurse or doctor at the MDT conference. The identified women will be
asked about the participation of the nurse / doctor at the new visit to the surgeon's
reception and bring written information home with them about the study. A few days after the
new visit, the woman is called by a researcher or nurse for further oral information and the
women who wish to participate will be given written informed consent. After this, baseline
measurement and randomization are performed to one of two groups. Evaluation will be
performed on two occasions, prior to surgery (baseline for pain and other symptoms,
demographic issues) and 3 weeks after surgery (pain, symptoms, clinical assessment of the
breast). Demographic (age, education, etc.) and medical information (weight, BMI, illness
history, smoking, alcohol habits and physical activity, etc.) as well as the type of surgical
procedure and drain are collected through medical records.
Inclusion
Women from 18 years of age with malignant tumor of the breast gland to undergo surgery.
Exclusion
Men with breast cancer. Women with benign tumors or women with health factors where the
assessment is that Bra use from healthcare is not necessary or possible.
Compliance and instruments
The participant will be instructed to use the bra according to. Instruction and adherence to
intervention will be via diary pages where the participant for 3 weeks briefly fills in
(number of days) and how often (number of hours / day) you have used the bra you received
from the health care. Primary outcome measure is; pain, secondary outcome measures are,
presence of seroma, symptoms after breast surgery mainly swelling, redness, and satisfaction
with the use of bra focusing on comfort and support. Instruments for self-estimated outcome
measures that will be used are;
- To measure the perception of pain comes the estimation instrument VAS (visual analogue
scale). VAS is a 10 cm long horizontal line where on one side measures "no pain" and on
the other "worst possible pain" and the patient places a mark on the line corresponding
to the perceived pain .
- To measure chest symptoms, EORCT QLQ-BR 23 will be used. BR 23 is a questionnaire that
measures common symptoms of breast cancer disease and treatment (eg you have had
difficulty lifting or moving your arm, have you had pain around your breast).
- The presence of wound complications, seroma and other symptoms reported by the patient
(swelling, redness) will be assessed by clinical assessment of the nurse and medical
record. E.g. Seroma will be assessed on the basis of a template based on the number of
drops and the amount / ml of dropped liquid.
To examine how participants experience the convenience, comfort, and support of the
postoperative bra they used in the study, participants will answer study-specific questions
(open and closed) regarding patient experience (patient satisfaction) regarding BRA use that
relates to comfort, support and comfort.
Intervention
Participants are randomized into one of two groups. Group 1) is offered the more stable bra
with some compression after breast cancer surgery, while Group 2) is offered a softer bra
without compression. Participants are encouraged to use the bra according to instructions and
record the number of hours / days for use in a diary. When returning to a nurse / doctor
after about 3 weeks of use, all participants respond to survey questions about pain, other
symptoms and experience of support and comfort during use, and undergo a clinical assessment
of the nurse according to a template with respect to seroma, number of taps, quantity and
occurrence of complications (eg wound infection). Compliance with intervention takes place
trough a simple diary which participants fill in for 3 weeks eg. how long (number of days)
and often (number of hours / day) have you used the bra you received from the healthcare
system, as well as grading daily pain according to the VAS- scale.
To determine if there are differences between 2 groups with respect to the variable pain as
the primary outcome measure, a sample size of 80 women per group is calculated to be
necessary with a power of 0.80 percent and a significance level of <0.05. Given that subgroup
analyzes (about 5 groups - mastectomy +- SN, mastectomy +- axillary, sector + - SN, sector +-
axillary and primary reconstruction) will be done and a planned 10% drop-out, 100 women per
group will be included.
Analysis
Quantitative data will be processed using relevant statistical parametric methods for
normally distributed data and non-parametric methods for non-normally distributed data.
Analyzes will investigate differences between groups as well as within the group (ANOVA) as
well as analyzes for the relationship between different parameters (eg type of bra and
surgical procedure). Demographic baseline data is reported as descriptive statistics (SD,
mean, frequency). Statistics will be used for support.
Ethical issues
The current research project will follow the basic ethical principles that include the
information requirement, the consent requirement, the confidentiality requirement and the use
requirement . Involved persons in the team for the BH study all have long experience of
meeting people with cancer diagnosis. Close ethical discussion with expertise in the research
group on the routines that exist today for bra use after surgery and in randomization so as
not to cause or risk injury to the woman. All participants will; receive oral and written
information about the study, have the opportunity to ask questions via telephone or mail
during the entire study period (the information requirement). Participants will be informed
that participation is completely voluntary and that there is no disadvantage if participation
is canceled (the consent requirement). Personal data will be de-identified and handled in
accordance with statutes to minimize the identity of the participants for unauthorized
persons in the reporting of results (the confidentiality requirement).
The collected data will only be used for research purposes (the use requirement).
