Informed Consent Form Protocol Title: Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory Version Number: V1.0 Version Date: April 1, 2024 Dear Subject: We invite you to participate in the study titled "Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory," which has been reviewed and approved by the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. This informed consent form will provide you with some information to help you decide whether to participate in this clinical study. Your participation in this study is entirely voluntary, and your decision will not affect your normal rights and treatment at this hospital. If you choose to participate in this study, our research team will make every effort to ensure your safety and rights throughout the research process. Please read carefully. If you have any questions, please ask the researcher responsible for this study. I. Research Background, Significance, and Objectives: 1.1 Background and Significance With the extension of average life expectancy, the number of elderly lung cancer patients has also increased, with patients over 65 years old accounting for more than 50%. Elderly patients often have other diseases, low organ function, decreased cardiopulmonary function after surgery, and poor tissue repair capacity and immune function, making them more susceptible to complications such as atelectasis, pulmonary infection, and respiratory failure. Studies have shown that moderate exercise can reduce the risk of lung cancer, improve cardiopulmonary function and fatigue, increase muscle endurance and quality of life, shorten hospital stay, and reduce the incidence, mortality, and complication rates of lung cancer. The American College of Sports Medicine (ACSM) and the American Cancer Society recommend a total exercise volume of 150 minutes of moderate-intensity exercise or 75 minutes of high-intensity exercise per week, or an equivalent combination. Studies have shown that nearly two-thirds of cancer patients do not meet the recommended exercise volume and face risks of cardiovascular disease, diabetes, and premature death after surgery. Several countries, including the United Kingdom and Australia, have conducted exercise-related studies in patients undergoing lung cancer surgery. However, there is limited research on postoperative exercise intervention for the special population of elderly lung cancer patients both domestically and internationally, and there is a lack of postoperative exercise guidance and postoperative exercise management guidelines. Therefore, it is urgent to develop an exercise management program for this population. 1.2 Research Objectives This study aims to provide strong theoretical support for clinical medical staff to standardly guide postoperative exercise in elderly lung cancer patients, and also provides a template for the best evidence clinical application for other studies. II. Research Process: This study is a single-center clinical study. The expected number of subjects participating at this center is 68. If you agree to participate in this study, you need to sign this informed consent form. Afterward, we will conduct inclusion and exclusion criteria assessment. If you meet the inclusion criteria and do not meet the exclusion criteria, you will be enrolled in this study and have a 1/2 chance of being assigned to the control group or the intervention group. The intervention period is from 1 day before surgery to 2 weeks after discharge. During hospitalization, a rehabilitation physician and a respiratory therapy physician will jointly conduct a risk assessment, supervise, and guide the intervention for you. The intervention includes aerobic exercise, resistance exercise, respiratory training, etc. The intervention frequency ranges from 1-2 times per day to 1-4 times per week. It will be repeatedly reinforced in combination with authoritative exercise guidance videos until you have mastered it. The main part of the exercise guidance video is the specific exercise program, including the exercise methods you can choose, the duration of each exercise session, the weekly exercise frequency, and the exercise intensity. Corresponding demonstration videos and pictures of movements will be provided according to the exercise method you choose, so that you can practice at home. At discharge, you need to join the postoperative rehabilitation group. We will send the intervention guidance videos to the group, and you can save the videos to your mobile phone for reference at any time. At discharge, the rehabilitation physician will provide you with a paper or electronic exercise program for 2 weeks after discharge according to your condition. You w
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
68
The team members include the principal investigator, 2 thoracic surgery specialist nurses, 2 rehabilitation medicine physicians, and 1 respiratory therapy physician. First, the principal investigator, rehabilitation medicine physicians, and respiratory therapy physician are responsible for filming videos on respiratory training, shoulder function exercises, and resistance exercise, as well as producing the exercise guidance manual. Second, the principal investigator and rehabilitation medicine physicians provide intervention program training to team members. The training content mainly includes content related to the exercise management program, including the standardized operation of the 6MWT, the use of the Borg Rating of Perceived Exertion scale, and the correct implementation of the exercise intervention program. For example: first, screening and assessment are conducted before exercise to determine the patient's physical condition and exercise capacity;
On the basis of receiving routine care, the intervention group underwent systematic exercise intervention according to the postoperative exercise management program for elderly lung cancer patients. The intervention period was from 1 day before surgery to the 2-week follow-up after discharge. The intervention content included aerobic exercise, resistance exercise, respiratory training, etc. The intervention frequency throughout the process was once every other day. The intervention process was repeatedly reinforced with videos and an exercise guidance manual until the patients mastered it. The exercise guidance manual mainly introduces the necessity and benefits of exercise after lung cancer surgery, including enhancing immunity, improving respiratory function, and preventing complications; explains the preparatory work before and after exercise, such as choosing appropriate time, place, clothing, and diet, as well as how to assess one's own exercise capacity and intensity;
Face-to-face intervention combined with telephone/WeChat remote intervention. During hospitalization, on day 1 before surgery, explain and sign the informed consent form, complete baseline data, add the patient's or family member's WeChat, and collect 6MWT data. After collection, the principal investigator gathers enrolled patients and family members to watch the postoperative exercise guidance video, provide on-the-spot teaching, promptly point out deficiencies, and use the Teach-back method for feedback until they correctly master the movement essentials, instructing family members to accompany and supervise exercise during hospitalization and at home. Give each patient an exercise guidance manual, informing them of exercise methods at different stages, exercise-related precautions, and how to keep exercise records during hospitalization and 2 weeks after discharge. In the postoperative exercise intervention stage, patients exercise according to the program.
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
six-minute walk test (6MWT)
Time frame: pre-intervention (T0, one day before surgery), during intervention (T1, day of chest tube removal), and post-intervention (T2, two weeks after discharge)
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