Prehabilitation in Breast Cancer Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

About this trial

This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-Based Prehabilitation Exercise Program

    Other intervention

    Participants assigned to this arm will receive a structured, home-based prehabilitation program initiated at least three weeks prior to surgery. The intervention includes: (1) moderate-intensity aerobic exercise (3 sessions per week, 30 minutes per session, target intensity RPE 4-6/10), (2) upper extremity resistance exercises using elastic bands (3 sessions per week, 3 sets of 10 repetitions per exercise), and (3) mobility and stretching exercises focused on shoulder function. The program will be delivered through written materials and instructional exercise videos accessible via QR code. Participants will receive elastic resistance bands for training. Adherence and progression will be monitored weekly via remote follow-up (telephone or email contact). The intervention is non-pharmacological and designed to optimize upper extremity function prior to breast cancer surgery.

  • Usual Care

    Other intervention

    Usual Preoperative Care

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Prehabilitation GroupExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Shoulder Range of Motion (degrees)

Measured by goniometer

Time frame
Baseline to 12 weeks post-op
2

DASH Score

Change in DASH Score The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item patient-reported outcome measure assessing upper extremity disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.

Time frame
Baseline to 12 weeks post-op

Secondary outcomes

1

Grip Strength

Grip Strength in kgs

Time frame
Baseline to 12 weeks post-op
2

Pain (Brief Pain Inventory - BPI)

Pain severity and pain-related interference will be assessed using the Brief Pain Inventory (BPI). The BPI evaluates pain intensity (0-10 numeric rating scale) and its impact on daily functioning. Higher scores indicate greater pain severity and interference.

Time frame
baseline to 12 weeks
3

Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)

Cancer-related fatigue will be measured using the FACT-F questionnaire. The scale consists of 13 items scored from 0 to 4, with total scores ranging from 0 to 52. Lower scores indicate greater fatigue severity.

Time frame
0-12 months
4

Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)

Functional disability will be assessed using the 12-item interviewer-administered WHODAS 2.0. Total scores range from 0 to 48, with higher scores indicating greater disability and functional impairment.

Time frame
baseline to 12 weeks

Other outcomes

Sponsors and contacts

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