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

NCT ID: NCT04979715

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-01-19

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.

Conditions

Breast Cancer Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group (Group 1)

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.

Group Type: EXPERIMENTAL

physitherapy follow-up

Intervention Type: PROCEDURE

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

control group (Group 2)

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.

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

no intervention; preoperative patient informaiton and information leaflet

routine follow-up (Group 3)

only preoperative patient information is given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

physitherapy follow-up

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

Intervention Type: PROCEDURE

control

no intervention; preoperative patient informaiton and information leaflet

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

ATİYE KAŞ ÖZDEMİR

Principal Investigator; Phd. PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevda YILMAZ, dr

Role: STUDY_CHAIR

Pamukkale University

Hande ŞENOL, dr

Role: STUDY_CHAIR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40987957 (View on PubMed)

Other Identifiers

2019SABE028

Identifier Type: -

Identifier Source: org_study_id