Clinical trial NCT06156397: The Effect of Technological Based Rehabilitation Practices After Breast Cancer Surgery
Official title: The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: rehabilitation
physical therapy
breast cancer
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with a conventional therapy control group
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

Detailed description: Breast cancer is the most common malignant tumor in women. According to the World Health Organization's 2018 data, 11.6% of new cancers worldwide are breast cancer. The overall 5-year survival rates of stage I, II, and III patients are 98%, 92%, and 75%, respectively. Therefore, the survival rate is increasing due to developments in cancer treatment.

The incidence of shoulder mobility impairment after breast cancer surgery was 2% \~ 51%. Postoperative patients' failure to exercise due to fear of pain and affected wound healing leads to poor activity of the upper extremity and shoulder joints, which often leads to limited activity and dysfunction in the affected extremities.

The use of technology in rehabilitation is rapidly increasing, and new technologies provide more motivational participation of patients in their usual care and standard programs. It has been reported that in the acute period after mastectomy, shoulder pain, fatigue, decreased joint range of motion and muscle strength, neuropathy, and consequent limitation of daily living activities.

It has been proven that passive mobilization, general exercise, manual stretching and traditional physiotherapy practices combining them are effective in treating upper extremity pain and restoring functionality after surgery.

There is no study in the literature investigating the effect of an application-based physiotherapy program on upper extremity dysfunction in patients undergoing breast cancer surgery. The aim of this study is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

Patients who underwent surgery and axillary lymph node dissection will participate in the study. The cases will be randomly divided into three groups. Conventional upper extremity exercises will be planned for the cases in Group 1, telerehabilitation based supervised exercise will be planned for the cases in Group 2, and mobile application-supported exercise treatment will be planned for the cases in Group 3.

In all groups, exercise side effects such as pain, discomfort, and lymphedema development will be monitored by the physiotherapist, with a weekly face to face meeting with the standard physiotherapy exercise group, and with a phone call every 7-10 days with the telerehabilitation and mobile application supported exercise group. Patients who experience adverse effects during or after treatment will be recorded and necessary precautions will be taken.

Treatment program; It will be carried out twice a week for 6 weeks. Each session is scheduled to be approximately 40-45 minutes. Evaluations will be made before and after the application.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with breast cancer and undergoing surgery and having axillary lymph node dissection performed during surgery
* Finding the cases in the post-operative (post-op) 2nd week
* Age range between 30 and 65 years
* Limited shoulder ROM in preoperative evaluations absence
* No speech or hearing problems
* Patients included in the study are volunteers

Exclusion Criteria:

* Previous ipsilateral or contralateral breast cancer surgery
* Presence of active or metastatic cancer focus
* A neurological disease that affects upper extremity functionality or
* Finding orthopedic surgery
* Having hearing or visual impairment
* Carrying a pacemaker
* Presence of infection and open wound
* Finding a drain after surgery
* Cases with mental and cooperation problems

Primary outcomes:
measure: Baseline Digital Goniometer
timeFrame: six weeks
Secondary outcomes:
measure: Disability of Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: six weeks
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
timeFrame: six weeks
measure: Muscle Strength Assessment
timeFrame: six weeks
measure: Tampa Kinesiophobia Scale (TKS)
timeFrame: six weeks
measure: Visual Analog Scale (VAS)
timeFrame: six weeks
measure: The Global Rating of Change (GRoC)
timeFrame: six weeks
measure: The Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: six weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: The University of Health Sciences Haydarpaşa Numune Hospital
state: Üsküdar
Study officials:
affiliation: Medipol University
name: Begüm Büyükerik
role: PRINCIPAL_INVESTIGATOR
References: