Clinical trial NCT06406868: Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors
Official title: Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Shoulder Functional Independece
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 3rd day
Secondary outcomes:
measure: Breast Cancer Therapy Functional Rating Scale (FACT-B)
timeFrame: 3rd day
measure: Goniometer
timeFrame: 3rd day
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Nishtar Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Qurat ul ain Khan, MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.