The Challenges of Conducting a Randomized Controlled Trial In Vietnamese Lung Cancer Population
Dau Van VU*, PhD, RN1, Hien Thi Thu PHAM, MSc, RN1, Huong Thi Thu PHAM, PhD, RN2
1Nam Dinh University of Nursing - No 257, Han Thuyen, Nam Dinh, Vietnam.
2Phenikaa University – Yen Nghia, Ha Dong, Hanoi, Vietnam
Background: Clinical Randomized Control Trial (RCT) on lung cancer subjects has one of the highest dropout rates. The aim of this report is to examine the challenging issue that arises with conducting an RCT in lung cancer with the title “Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung cancer patients: A randomized control trial” and to suggest possible resolutions.
Materials and Method: One hundred and fifty-six patients were recruited and randomly assigned to either the Qigong group (n=78) or the wait-list control group (n=78). A 6 week Qigong practice program was conducted that comprised of 2 weeks training at a hospital then home-based practice 30 min per day for 5 days per week. A DVD, a logbook and weekly phone calls were provided to the Qigong group.
Results: Multiple challenging issues were identified and were regrouped as the patients at hospitals in Vietnam are not familiar with research study or RCT. The intervention is complex involving attending a workshop and practices Qigong with many steps and over a period with home practice. Heavy disease burden of lung cancer patients have some affect exercising significantly such as, breathless and fatigue Patients’ cultural belief in self-care and taking care of the family, ‘No’ comfortable place for patients during data collection, hospitals administrations are too busy, do not have time to cooperate and lack of support for research project.
Conclusions: A clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential challenging and facilitators to reduce attrition rate in trials, have a realistic timeline, define a clear objective and precise endpoints, balance the study with correct randomization are key elements that help us assuring a strong study’s validity.
RCT challenge, Lung cancer, Qigong, Clinical trials