| CTRI Number |
CTRI/2016/04/006897 [Registered on: 29/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercises] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of exercise protocol in decreasing pain,numbness and swelling in arm,improving range of motion and strength in arm and improving quality of life among women with breast cancer who have undergone breast surgery. |
|
Scientific Title of Study
|
A study to assess the effectiveness of exercise protocol on upper arm dysfunction and quality of life among women with breast cancer who have undergone mastectomy with axillary lymph node dissection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHASHI BALA |
| Designation |
Msc Nursing Student |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
College of Nursing ,All India Institute of Medical Sciences
Ansari Nagar,AIIMS,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9821418693 |
| Fax |
|
| Email |
sasi83bala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRachel Andrews |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
College of Nursing,All India Institute of Medical Sciences
Ansari Nagar,AIIMS,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9953224917 |
| Fax |
|
| Email |
gaddamrachel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Srivastava |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Room no.5027,Surgery Office,5th Floor,Teaching Block,All India Institute of Medical Sciences
Ansari Nagar,AIIMS,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9868397729 |
| Fax |
|
| Email |
dr.anuragsrivastava@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anurag Srivastava |
| Address |
Room no.5027,Dept of Surgery,All India Institute of Medical Sciences |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anurag Srivastava |
All India Institute Of Medical Sciences |
Treatment room of surgery ward and surgical oncology ward and surgery outpatient department and breast cancer clinic
South
DELHI |
9868397729
dr.anuragsrivastava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research,All India Institute Of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Upper arm dysfunction and quality of life among women with breast cancer who have undergone mastectomy with axillary lymph node dissection. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise protocol (exercises to decrease upper arm dysfunction)
|
Exercise till 1 week after surgery,exercises from 2nd to 8th week after surgery |
| Comparator Agent |
Normal post mastectomy exercises |
Normal post mastectomy exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with unilateral Breast cancer admitted in surgical ward and BRAIRCH oncology ward , AIIMS and are scheduled for mastectomy with axillary lymph node dissection.
Patients who are able to follow instructions.
Patients who have given consent for participation in the study.
Able to communicate in Hindi /English .
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Patients who have major health problems or disabilities like gross obesity (BMI >35 ), Cardiovascular diseases (angina , MI within last 6 months).
Patients having primary lymphedema and any contraindication to the affected upper-limb exercises(e.g., venous thrombosis)..
Patients who are not able to follow instructions.
Patients who have cognitive dysfunction .
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Upper arm dysfunction assessed by Disability of Arm Shoulder and Hand Questionnaire
(DASH) score from pretest to postest |
3 time points,1 pretest and 2 posttest |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life assessed by European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30)and Breast module(EORTC-QLQ-BR23) |
3 time points,1 pretest and 2 posttest |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized controlled trial to assess the effectiveness of exercise protocol in decreasing upper arm dysfunction and improving quality of life among the women who have undergone mastectomy with axillary lymph node dissection. Breast cancer patients who have undergone mastectomy with axillary lymph node dissection were randomized to experimental and control group.Experimental group received exercise protocol while control group received routine /standard care.Pretest was taken from both groups .Then intervention was started in experimental group.Post test was taken in both groups at 2weeks after surgery and at 8 weeks after surgery.
Objectives of the study are 1.To assess upper arm dysfunction among women with breast cancer who have undergone mastectomy with axillary lymph node dissection. 2.To evaluate the effectiveness of exercise protocol on upper arm dysfunction
among women with breast cancer who have undergone mastectomy with axillary lymph node dissection. 3.To evaluate the effectiveness of exercise protocol on quality of life among women with breast cancer who have undergone mastectomy with axillary lymph node dissection. Hypothesis1-There will be a decrease in upper arm dysfunction from pretest to postest among patients in experimental group as compared to control group assessed by DASH scores at significant p value <0.05
Hypothesis2-There will be a increase in quality of life from pretest to postest among patients in experimental group as compared to control group assessed by EORTC-QLQ-C30 and EORTC-QLQ-BR23 scores at significant p value <0.05
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