Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

May 8, 2024 updated by: Riphah International University

Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors

This study is comparing two interventions to identify effective treatment for breast cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tele rehabilitation has gained popularity during Covid 19 pandemic. All the studies carried out at that time was found effective in many countries. Still a literature gap is present in tele rehabilitation in breast cancer patients in Pakistan. Prevalence of breast cancer is high in Pakistan. Now it is the best time to implement tele rehabilitation for breast cancer patients as it will reduce treatment costs and travel expenses. Therefore, the goal of this RCT is to consider tele rehabilitation as part of our treatment plan because if it is found effective for patients than it will be helpful in the field of health and technology.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Multān, Punjab, Pakistan, 66000
        • Recruiting
        • Nishtar Hospital
        • Contact:
        • Principal Investigator:
          • Leena Shakeel, MS-WHPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: American Cancer Society

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
Other: American Cancer Society

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

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Qurat ul ain Khan, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

June 7, 2024

Study Completion (Estimated)

June 14, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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