The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions

NCT04979715 | Completed

• 1 other identifier: 2019SABE028
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer Surgery

Keywords

breast cancer; physical functions; psychosocial functions; breast cancer physiotherapy; breast cancer survival; breast cancer surgery

Outcome Measures

Primary Outcomes (12)

• determination of limb volume changes

  The circumference measurements for lymphedema will be calculated using the Frustum formula. calculations will compare with operated and non-operated limb, and also subsequent measurements. A volume increase of \>200 ml is interpreted as the onset of lymphedema.

  postoperative to 3 months later

• determination of shoulder and upper extremity functions

  Modified Constant Murley Score for assessment of shoulder and upper extremity functions. high score indicates good function.

  postoperative to 3 months later

• muscle shortness test

  Pectoralis major and pectoralis minor muscle shortness tests.measurements will compare with operated and non-operated limb, and also subsequent.

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination; weight

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body weight (kg), muscle mass (kg), estimated bone ratio (kg).

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination;body mass index

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body mass index (kg/m2).

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination; body fat and water percentage

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body fat percentage, body water percentage.

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination; visceral fat level

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; visceral fat level.

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination; energy consumption

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; total daily energy consumption (kcal/day).

  postoperative to 3 months later

• Bioimpedance analysis for body composition determination; metabolic age

  Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; metabolic age (years).

  postoperative to 3 months later

• determination of subdermal fluid ratio

  Moisturemeter compactD for measurement of subdermal fluid ratio. Measurements will be compared with the subsequent.

  postoperative to 3 months later

• assesment of fatigue

  Cancer Fatigue Scale for assesment of fatigue. A low score indicates a low fatigue rate.

  postoperative to 3 months later

• determination of cardiovascular endurance

  6 Minute Walk Test (6MWT) will be used for cardiovascular endurance.Changes of \>35 m are significant changes.

  postoperative to 3 months later

Secondary Outcomes (2)

• determination of emotional status

  baseline to 3 months later

• Determination of quality of life

  postoperative to 3 months later

Study Arms (3)

intervention group (Group 1)

EXPERIMENTAL

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.

Procedure: physitherapy follow-up

control group (Group 2)

ACTIVE COMPARATOR

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.

Other: control

routine follow-up (Group 3)

NO INTERVENTION

only preoperative patient information is given.

Interventions

physitherapy follow-up PROCEDURE

preoperative patient informaiton, information leaflet and Physiotherapy meeting will be held every 2 weeks for 3 months

intervention group (Group 1)

control OTHER

no intervention; preoperative patient informaiton and information leaflet

control group (Group 2)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20350, Turkey (Türkiye)

Location

Related Publications (1)

• Kas Ozdemi̇r A, Telli Atalay O, Yilmaz S, Senol H. The effects of early rehabilitation on physical and psychosocial functions after breast cancer surgery. Support Care Cancer. 2025 Sep 23;33(10):872. doi: 10.1007/s00520-025-09926-4.

  PMID: 40987957 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sevda YILMAZ, dr

  Pamukkale University

  STUDY CHAIR

• Hande ŞENOL, dr

  Pamukkale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know which group they belong to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Phd. PT

Model Details: intervention (Group 1), control (Group 2) and routine follow-up (Group 3) groups

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 28, 2021
• Study Start: July 1, 2020
• Primary Completion: December 19, 2021
• Study Completion: January 19, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)