None listed
Conditions
Brief summary
This study will assess the feasibility of a fully-powered randomized controlled trial using an integrative Tai Chi (ANITA) program for breast cancer patients undergoing cancer therapy. We will recruit 24 breast cancer patients from the Breast Cancer Services and the Oncology Department in the Dunedin Hospital. Participants will be recruited over a 12 month window, and subject to informed consent, will be offered the ANITA program in addition to regular cancer treatment. This program will run from 4 weeks post-surgery through to participant’s breast cancer treatments. Analysis will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes (i.e. fatigue, sleep quality, anxiety and depression, and quality of life) will be assessed at baseline, and at 12 weeks and 24 weeks post randomization.
Interventions
For those participants randomized to the intervention group, they will receive an integrative Tai Chi (ANITA) program that consists of peer support, health education, and Tai Chi Ruler exercise, in addition to breast cancer conventional treatments as described below, This program will run from 4 weeks post-surgery through to participant’s breast cancer treatments. 1) Peer support groups After group allocation, participants in the intervention group will be invited to join peer support groups hosted by the Otago/Southland Division of the New Zealand Cancer Society. This well-established group is held once per month, being made up of breast cancer patients who have completed cancer therapy and the ones undergoing treatment. The group is formed to be an interactive environment, and provides support and understanding for participants. Furthermore, it serves as a regular social activity and networking opportunity among breast cancer patients. 2) Health education seminars Seminars will provide participants knowledge for effective self-care and improving quality of life. These seminars will be held every two months at the Otago/Southland Division of the New Zealand Cancer Society, prior to the routine peer support groups. Each seminar will last for 40 minutes, and be delivered by guest speakers with different, relevant expertise such as general practitioner, nutritionist, physiotherapist, and psychotherapist. These sessions will provide participants and their families with knowledge on post-surgery self-care, nutrition, sleep and fatigue, stress management, and social support. 3) Tai Chi Ruler exercise The 24-weeks exercise program consists of a 12-week instructor-led Tai Chi Ruler class, followed by a 12-week Tai Chi Ruler home-based practice. Tai Chi Ruler is selected as the exercise form as it is easier to learn for beginners than the longer and more complex traditional forms. For the first 12 weeks, participants will be advised to attend a group-based Tai Chi Ruler exercise class at the School of Physiotherapy, twice per week. Class times will be decided at the participants’ convenience to accommodate work and/or treatment schedules, and cohort classes will be provided if necessary. Classes will be instructed by a trained Tai Chi instructor with two years’ experience of leading Tai Chi classes in people with chronic health issues and post-surgery. Exercise protocol for the Tai Chi program will be developed by reviewing previous Tai Chi studies (for breast cancer survivors), and through consultation with an experienced Tai Chi expert at the School of Physiotherapy. Each class will take 60 minutes, consisting of a 15-minute warm-up, 35-minutes of Tai Chi Ruler movements, and a 10-minute cool-down. Participants will be informed that all movements can be performed in a sitting position if necessary; modifications will be made for individuals with range of motion limitations. On completion of the classes, each participant will receive a CD containing practice music of the Tai Chi Ruler exercise to facilitate their home practice. Participants will be asked to practice Tai Chi Ruler exercise at home (at least) twice per week for 12 weeks; practice will follow the same procedure of the classes. Adherence with the home practice will be captured using a structured activity logbook provided to participants at discharge. Participants are asked to complete the logbooks, and return these logbooks to the blinded research assistant by post on completion of the 12-weeks Tai Chi Ruler home practice. The Tai Chi instructor will follow-up participants by emails or phone calls every two weeks, reinforce the value of exercise adherence, and answer any queries and concerns participants may have.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be eligible to participate in this trial if they are: (1) patients diagnosed with breast cancer of stage I, II, or III; (2) over 4 weeks since completing surgical treatment; (3) waiting for, or currently undergoing adjunct cancer therapy including chemotherapy, radiation therapy, and/or hormonal therapy; (4) judged as either Grade 0 or 1 of the Eastern Cooperative Oncology Group (ECOG) performance status; (5) willing to be randomized to and to attend the ANITA program at the School of Physiotherapy; (6) able to read and communicate in English.
Exclusion criteria
Participants are excluded from participation in this trial if they have: (1) regular practice of Tai Chi, qigong, or yoga within the past 3 months; (2) a history of health conditions precluding participation in an exercise regime (e.g. severe cardiovascular, liver, or kidney diseases, and severe dementia).