Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: American Cancer Society

• Registration Number: NCT06406868
• Lead Sponsor: Riphah International University

Brief Summary

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

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 Timeline

• Study Start: 2024-02-07
• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehablitation	American Cancer Society	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
Outpatient Rehablitation	American Cancer Society	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

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	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.

Secondary Outcome Measures

Name	Time	Method
Goniometer	3rd day	Changes from baseline ROM of shoulder was taken with the help of goniometer
Breast Cancer Therapy Functional Rating Scale (FACT-B)	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

Trial Locations

Locations (1)

Nishtar Hospital; 🇵🇰 Multān, Punjab, Pakistan