Yu-Wei Shao1,2, Qing Shu2, Dan Xu2, Hui Teng2, Gao-Song Wu3, Jin-Xuan Hou3, Jun Tian4. 1. The Second Clinical College of Wuhan University, Wuhan, Hubei, China. 2. Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. 3. Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. 4. Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. tianjun@znhospital.cn.
Abstract
INTRODUCTION: Due to advancements in treatment, the survival of breast cancer (BC) patients has significantly improved. Improving the postoperative quality of life has become a widespread concern for patients and doctors. At present, the staged rehabilitation training program for postoperative BC patients has been recognized. However, there is not yet a consensus about the optimal time to initiate rehabilitation training. We designed this study to investigate the optimal intervention times for postoperative BC patients to begin different stages of rehabilitation. DESIGN: This is a randomized controlled trial. Female participants with BC who are scheduled to undergomastectomy, including unilateral total breast or breast-conserving surgery plus axillary lymph node dissection, will be enrolled in this study. The intervention includes the following: 200 participants will be allocated using a 1:1:1:1 ratio to the A, B, C, and D groups, which have four different rehabilitation timelines for four phases of rehabilitation exercises. A therapist will evaluate the patient's overall health and then adjust the training intensity before initiating training. The assessments include upper limb mobility, grip, limb circumference, postoperative drainage volume (PDV), and pain. The training will last for 12 weeks, and patients will undergo follow-up twice within 6 weeks after discharge. Outcomes include the following: Constant-Murley Score (CMS) is the primary parameter. European Organization Research and Treatment of Cancer Quality of LifeQuestionnaire-BR23 (EORTC QLQ-BR23), SF-36, range of motion (ROM), strength, grip, circumference, PDV, and pain are the secondary parameters. All enrolled subjects will be assessed at 1 day, 3 days, 1 week, and 2, 3, 6, 9, 12, and 18 weeks after the surgery. DISCUSSION: This is a randomized controlled trial to evaluate the effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative patients with BC. If the results are confirmed, this study will establish an optimal timeline for postoperative BC rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658265 . Registered on September 2018.
RCT Entities:
INTRODUCTION: Due to advancements in treatment, the survival of breast cancer (BC) patients has significantly improved. Improving the postoperative quality of life has become a widespread concern for patients and doctors. At present, the staged rehabilitation training program for postoperative BC patients has been recognized. However, there is not yet a consensus about the optimal time to initiate rehabilitation training. We designed this study to investigate the optimal intervention times for postoperative BC patients to begin different stages of rehabilitation. DESIGN: This is a randomized controlled trial. Female participants with BC who are scheduled to undergo mastectomy, including unilateral total breast or breast-conserving surgery plus axillary lymph node dissection, will be enrolled in this study. The intervention includes the following: 200 participants will be allocated using a 1:1:1:1 ratio to the A, B, C, and D groups, which have four different rehabilitation timelines for four phases of rehabilitation exercises. A therapist will evaluate the patient's overall health and then adjust the training intensity before initiating training. The assessments include upper limb mobility, grip, limb circumference, postoperative drainage volume (PDV), and pain. The training will last for 12 weeks, and patients will undergo follow-up twice within 6 weeks after discharge. Outcomes include the following: Constant-Murley Score (CMS) is the primary parameter. European Organization Research and Treatment of Cancer Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23), SF-36, range of motion (ROM), strength, grip, circumference, PDV, and pain are the secondary parameters. All enrolled subjects will be assessed at 1 day, 3 days, 1 week, and 2, 3, 6, 9, 12, and 18 weeks after the surgery. DISCUSSION: This is a randomized controlled trial to evaluate the effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative patients with BC. If the results are confirmed, this study will establish an optimal timeline for postoperative BC rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658265 . Registered on September 2018.
Authors: Gabriel N Hortobagyi; Jaime de la Garza Salazar; Kathleen Pritchard; Dino Amadori; Renate Haidinger; Clifford A Hudis; Hussein Khaled; Mei-Ching Liu; Miguel Martin; Moise Namer; Joyce A O'Shaughnessy; Zhen Zhou Shen; Kathy S Albain Journal: Clin Breast Cancer Date: 2005-12 Impact factor: 3.225
Authors: Helen Richmond; Clare Lait; Cynthia Srikesavan; Esther Williamson; Jane Moser; Meredith Newman; Lauren Betteley; Beth Fordham; Sophie Rees; Sarah E Lamb; Julie Bruce Journal: BMC Health Serv Res Date: 2018-06-18 Impact factor: 2.655