Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors
Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Multān, Punjab, Pakistan, 66000
- Recruiting
- Nishtar Hospital
-
Contact:
- Qurat-ul-ain Khan, MS
- Phone Number: 0315 5246605
- Email: quratulain.ggc@riphah.edu.pk
-
Principal Investigator:
- Leena Shakeel, MS-WHPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 30 to 60 years.
- Breast Cancer Females who underwent mastectomy (Simple total mastectomy).
- Breast Cancer Females without chemotherapy or radiotherapy treatment.
- Accessibility to smart phone.
- Internet access.
Exclusion Criteria:
- Previous history of breast or any other cancer.
- Females with metastatic breast cancer.
- Any Chronic pathology that will result in an increase in symptoms due to physical exercise.
- Any contraindications limiting physical activity.
- Shoulder radiculopathy, or fracture.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehablitation
The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. Frequency :10 repetitions Intensity: Moderate Time: Once a day |
After taking base line readings the patients will be divided into two groups' experimental group and control group by randomization. The experimental group will receive tele rehabilitation and the control group will receive outpatient rehabilitation. Readings will be taken at the end of every week. The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. The exercise plan will start on third day of surgery. A pictorial reference will be given to every patient to perform exercise. The exercise session will be thrice a week, for 60 min, and for four consecutive weeks, for 12 sessions. Exercise plan consists of three phases: warm up, balance exercise ,cool down |
|
Active Comparator: Outpatient Rehablitation
The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. Frequency :10 repetitions Intensity: Moderate Time: Once a day |
After taking base line readings the patients will be divided into two groups' experimental group and control group by randomization. The experimental group will receive tele rehabilitation and the control group will receive outpatient rehabilitation. Readings will be taken at the end of every week. The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. The exercise plan will start on third day of surgery. A pictorial reference will be given to every patient to perform exercise. The exercise session will be thrice a week, for 60 min, and for four consecutive weeks, for 12 sessions. Exercise plan consists of three phases: warm up, balance exercise ,cool down |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: 3rd day
|
Changes from baseline are taken shoulder pain disability index is developed to measure shoulder functional independence.It contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability.
|
3rd day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breast Cancer Therapy Functional Rating Scale (FACT-B)
Time Frame: 3rd day
|
Changes from baseline are taken FACT-B assesses the various domains such as, Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being, and Additional concerns specific to breast cancer patients.Score ranges from 0 to 148, with 148 a good score
|
3rd day
|
|
Goniometer
Time Frame: 3rd day
|
Changes from baseline ROM of shoulder was taken with the help of goniometer
|
3rd day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Qurat ul ain Khan, MS, Riphah International University
Publications and helpful links
General Publications
- Ng R, Lee CF, Wong NS, Luo N, Yap YS, Lo SK, Chia WK, Yee A, Krishna L, Goh C, Cheung YB. Measurement properties of the English and Chinese versions of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in Asian breast cancer patients. Breast Cancer Res Treat. 2012 Jan;131(2):619-25. doi: 10.1007/s10549-011-1764-z. Epub 2011 Sep 16.
- Akram M, Iqbal M, Daniyal M, Khan AU. Awareness and current knowledge of breast cancer. Biol Res. 2017 Oct 2;50(1):33. doi: 10.1186/s40659-017-0140-9.
- van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.
- Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y.
- Lee CH, Chung SY, Kim WY, Yang SN. Effect of breast cancer surgery on chest tightness and upper limb dysfunction. Medicine (Baltimore). 2019 May;98(19):e15524. doi: 10.1097/MD.0000000000015524.
- Akca M, Ata A, Nayir E, Erdogdu S, Arican A. Impact of Surgery Type on Quality of Life in Breast Cancer Patients. J Breast Health. 2014 Oct 1;10(4):222-228. doi: 10.5152/tjbh.2014.1919. eCollection 2014 Oct.
- Rasmussen GHF, Kristiansen M, Arroyo-Morales M, Voigt M, Madeleine P. Absolute and relative reliability of pain sensitivity and functional outcomes of the affected shoulder among women with pain after breast cancer treatment. PLoS One. 2020 Jun 3;15(6):e0234118. doi: 10.1371/journal.pone.0234118. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01729 Qurat ul ain Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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