Breast Cancer Clinical Trial
Official title:
The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery
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.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | February 15, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | The University of Health Sciences Haydarpasa Numune Hospital | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline Digital Goniometer | The initial and final shoulder range of motion (ROM) of the patients will be recorded in degrees using a digital goniometer. Shoulder ROM measurements will be measured bilaterally and using a standardized protocol. | six weeks | |
Secondary | Disability of Arm, Shoulder and Hand Questionnaire (DASH) | The Injuries to the Arm, Shoulder, and Hand (DASH) questionnaire was developed by the American Academy of Orthopedic Surgeons to assess upper extremity disability and symptoms. The DASH survey consists of three parts. The first part consists of 30 questions that determine the patient's function - symptom score. The first 21 of these questions evaluate the difficulty the patient experiences in performing daily life activities, 5 questions evaluate upper extremity symptoms (pain, pain that occurs with activity, tingling, weakness and difficulty in movement), and the remaining questions evaluate sleep, work, the patient's self-confidence and social life. | six weeks | |
Secondary | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) | The scale is grouped under three subheadings containing 30 questions. Sub-beliefs are the general well-being scale, the functional scale including the subheadings of physical function, general function, cognitive function, mental function and social function, and the symptom consisting of fatigue, pain, stomach brain - enthusiasm, dyspnea, insomnia, fatigue, constipation, diarrhea and material. It includes the scale. The first 28 of the 30 questions in the scale are a four-point Likert type scale and the items are; It is evaluated as Not at all: 1, A little: 2, Quite a bit: 3 or A lot: 4 points. In the 29th and 30th questions of the scale, the patient can be assigned a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, a general quality of life evaluation is requested. All scales are scored between 0-100. A high score from the functional scale section indicates good functional status, while a high score from the symptom scale section indicates low vitality. | six weeks | |
Secondary | Muscle Strength Assessment | The upper extremity muscle strength of the subjects will be measured with the J Tech Commander Muscle Tester® manual dynamometer during maximal voluntary isometric muscle contraction. Measurements will be made on the affected and healthy side upper extremities, shoulder flexion and abduction muscle strength in the sitting position, and internal and external rotation muscle strength in the supine position. Hand grip strength was evaluated with the Saehan Hydraulic Hand Dynamometer. Measurements will be made on the affected side in a sitting position as defined by the American Society of Hand Therapists, shoulder adducted, arm next to the body, elbow 90° flexed, forearm and wrist in neutral position. The results will be recorded in kg and each measurement will be repeated three times. For result measurements, the values will be averaged and a one-minute rest period will be given between measurements. |
six weeks | |
Secondary | Tampa Kinesiophobia Scale (TKS) | Individuals' fear of movement levels will be evaluated using the Tampa Kinesiophobia Scale (TKS). TKS is a checklist consisting of 17 questions and was developed to measure fear of movement/re-injury. The scale evaluates fear of movement with a 4-point Likert-type scoring system (1 = I strongly disagree, 4 = I completely agree). 4,8,12,16. While the total score calculated by reversing the questions is determined between 17-68, a higher score means that the person has a greater fear of movement. | six weeks | |
Secondary | Visual Analog Scale (VAS) | VAS is one of the simple and common methods used to evaluate pain intensity. It is a 10 cm long ruler and generally does not have any markings, numbers or writings on it. Patients are asked to mark the appropriate range for their pain at rest and during activity on a 10 cm long chart (0: no pain; 10 is unbearable pain). The point marked by the patients is measured and recorded in millimeters from the left end with the help of a ruler. It is included in the literature as a sensitive and reliable method. | six weeks | |
Secondary | The Global Rating of Change (GRoC) | The Global Rating of Change (GRoC) is a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment. | six weeks | |
Secondary | The Functional Assessment of Cancer Therapy - Breast (FACT-B) | The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients. | six weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |