Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03762694
Brief Summary:
This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.
Detailed Description:
Hypothesis:
Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.
Objective:
To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.
Design and strategy:
This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management.
Study instrument:
Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.
Intervention:
In the treatment group, 12 sessions acupuncture treatment (electroacupuncture \& auricular acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group.
Main outcome measures:
Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.
Secondary outcomes:
Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, and adverse events will be documented and compared between groups.
Data analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken.
Expected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.
Study:
NCT03762694
Study Brief:
Protocol Section:
NCT03762694