Clinical trial NCT04979715: The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions
Official title: The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Keywords: breast cancer
physical functions
psychosocial functions
breast cancer physiotherapy
breast cancer survival
breast cancer surgery
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 63
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: intervention (Group 1), control (Group 2) and routine follow-up (Group 3) groups
Primary purpose: TREATMENT

Brief summary: At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Those who met the criteria for inclusion in the study and those who voluntarily agreed to participate in the study, who were preoperatively evaluated, will be randomly divided into two groups using the closed envelope method by matching age, gender, type of surgery and breast cancer stage. The first of these groups is the study (n=21) and the second is the control group (n=21).

Detailed description: Study group: Patients in the study group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. After obtaining the consent of the surgeon performing the operation, preoperative and post-operative complications (infection, lymphedema, fatigue...) and the things to be considered (use of upper extremities, skin care, importance of weight control...) and patient education will be given by the physiotherapist. In addition, respiratory control, diaphragmatic breathing, relaxation exercises, gradual passive-active assistive-active range of motion exercises, stretching exercises will also be demonstrated preoperatively.

From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.

At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging...) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.

Participants will continue the exercises as a home program after discharge. During this follow-up period, the participants will meet again with the physiotherapist every two weeks for the control, compliance and continuity of the exercises. In these interviews, while compliance with the exercise program is checked, exercise tolerance will also be determined and necessary interventions and modifications will be made. In case of any complication (limitation in physical functions, lymphedema...) during the home program, he will be informed about meeting with the relevant physician and physiotherapist as soon as possible.

Control group: The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.

Written consent of all participants was obtained; demographic information will be recorded, and their physical and psychosocial conditions will be evaluated. Circumference measurements for lymphedema The extremity volume will be calculated using the Frustum formula. Modified Constant Murley Score for shoulder and upper extremity loss of function and evaluation of activities of daily living, pectoralis major and pectoralis minor shortness tests, Tanita for body composition determination, L-Dex score for bioimpedance analysis, Functional Evaluation of Breast Cancer Treatment for functional status ( Functional Assessment of Cancer Therapy -Breast Cancer - FACT-B scale, Cancer Fatigue Scale for fatigue, 6 Minute Walk Test (6MWT) for cardiovascular endurance and Hospital Anxiety and Depression Scale (HAD) for psychosocial status will be used. All measurements will be repeated preoperatively (at least 3 days before the operation), on the 1st postoperative day and 3 months later.

Eligibility criteria: Inclusion Criteria:

* Having a breast surgery indication with a diagnosis of breast cancer
* Having stage 1-2-3 breast cancer
* Education level to be at least literate
* To be in stable clinical condition
* Not having any other disease that will affect their physical and psychosocial functions
* Being good at cooperation
* Referred by the relevant surgeon and no contraindications for early postoperative physiotherapy

Exclusion Criteria:

* History of previous breast cancer surgery
* Concurrent bilateral breast cancer and/or surgery
* History of shoulder surgery
* Preoperative shoulder dysfunction
* Upper extremity deep vein thrombosis
* BMI\>40 kg/m²
* Use of an assistive walking device
* Stage 4 metastatic cancer
* All conditions that require close monitoring during exercise (such as uncontrolled or unstable cardiovascular disease or diabetes)
* cognitive impairment

Primary outcomes:
measure: determination of limb volume changes
timeFrame: postoperative to 3 months later
measure: determination of shoulder and upper extremity functions
timeFrame: postoperative to 3 months later
measure: muscle shortness test
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination; weight
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination;body mass index
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination; body fat and water percentage
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination; visceral fat level
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination; energy consumption
timeFrame: postoperative to 3 months later
measure: Bioimpedance analysis for body composition determination; metabolic age
timeFrame: postoperative to 3 months later
measure: determination of subdermal fluid ratio
timeFrame: postoperative to 3 months later
measure: assesment of fatigue
timeFrame: postoperative to 3 months later
measure: determination of cardiovascular endurance
timeFrame: postoperative to 3 months later
Secondary outcomes:
measure: determination of emotional status
timeFrame: baseline to 3 months later
measure: Determination of quality of life
timeFrame: postoperative to 3 months later
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Sevda YILMAZ, dr
role: STUDY_CHAIR
affiliation: Pamukkale University
name: Hande ŞENOL, dr
role: STUDY_CHAIR
References: