Unique ID issued by UMIN | UMIN000018593 |
---|---|
Receipt number | R000021516 |
Scientific Title | The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial |
Date of disclosure of the study information | 2015/08/07 |
Last modified on | 2024/02/14 19:26:39 |
The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial
Improving Upper Arm Dysfunction in Breast Cancer
The Perioperative Educational Program for Improving Upper Arm Dysfunction in Patients with Breast Cancer:A Prospective, Long-term, Controlled Trial
Improving Upper Arm Dysfunction in Breast Cancer
Japan |
Breast Cancer
Breast surgery | Nursing |
Malignancy
NO
To investigate the effectiveness of the perioperative educational program for improving upper arm dysfunction in breast cancer patients.
Efficacy
Confirmatory
Not applicable
shoulder range of motion, arm girth, grip strength
Outcome time:14 times of preoperation for 1 week for 1 month for 3 months 6 months later for every 6 months of 5 years after surgery.
Subjective Perception of Post-Operative Functional Impairment of the Arm(SPOFIA), Disabilities of the Arm,Shoulder and Hand(DASH), Medical Outcome Study 36-Item Short-Form Health Survey V2(SF-36v2), self care
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Educational,Counseling,Training
Behavior,custom |
monitoring of arm function, exercises, massage, and lifestyle adjustments/standard routine care from the on-site staff
Intervention time:14 times of preoperation for 1 week after surgery for 1 month for 3 months 6 months later for every 6 months of 5 years follow-up.
Once approximately from 30 minutes to 1 hour.
standard routine care from the on-site staff
20 | years-old | <= |
Not applicable |
Female
going to receive surgery, ECOG performance status 0-2, ability to respond to a self-administered questionnaire and no history of a diagnosis or treatment for mental illness, provided written informed consent
bilateral breast cancer, recurrence
66
1st name | Fumiko |
Middle name | |
Last name | SATO |
Tohoku University Graduate School of Medicine
Division of Oncology Nursing, Health Sciences
980-8575
2-1 Seiryo-machi, aoba-ku,Sendai, Miyagi, Japan
022-717-7926
fsato@med.tohoku.ac.jp
1st name | Fumiko |
Middle name | |
Last name | Sato |
Fukushima Medical University
School of Nursing
960-1295
1, Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan,
+81245471874
stfumiko@fmu.ac.jp
Tohoku University Graduate School of Medicine
Fumiko Sato
KAKEN
Japanese Governmental office
Japan
Ethics Committee, Graduate School of Medicine, Tohoku University
2-1 Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8575 Japan
+81-22-728-4105
https://www.rinri.med.tohoku.ac.jp/portal/
NO
東北大学病院(宮城県)
2015 | Year | 08 | Month | 07 | Day |
Partially published
Prior to surgery the preoperative upper limb function was not significantly different between the intervention group and the control group. Upper arm circumference diameter in the intervention group The difference on the side of the affected side decreased on 5 years after surgery, but the control group increased significantly compared with 1 week after surgery. Shoulder joint flexion and abduction were significantly improved both in the intervention group (F = 28.9; p <.001) and in the control group (F = 13.9; p <.001) 5 years after surgery, but horizontal extension was intervention Only the group improved significantly (t = -2.09; p <.05). The SPOFIA score decreased significantly in the intervention group 5 years after surgery, but there was no significant difference in the control group. DASH significantly decreased in both groups in comparison between 1 week postoperatively and 5 years postoperatively. Interventional programs for prevention and improvement of upper limb dysfunction of breast cancer experienced persons up to 5 years after surgery suggested educational effect to improve upper limb swelling, shoulder joint movement range, and subjective symptoms of the arm.
Completed
2009 | Year | 11 | Month | 30 | Day |
2009 | Year | 11 | Month | 30 | Day |
2010 | Year | 01 | Month | 13 | Day |
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2015 | Year | 08 | Month | 07 | Day |
2024 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021516
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |