Validity and Reliability of the Indonesian Version of the Brief Fatigue Inventory in Cancer Patients

et al. 2019

Trials

BackgroundFatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited.Method/designThis is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT.DiscussionThis trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.Trial registrationChinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019.URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

Section: Methodsmentioning

confidence: 99%

Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

et al. 2019

Trials

“…The Brief Fatigue Inventory scale is designed by Mendoza [18] and translated by Wang [19], and it is comprised grades, that is no fatigue (score 0), mild fatigue (score 1-3), moderate fatigue (score 4-6), and severe fatigue (score 7-10). The BFI scale has been validated in different cancer patients all over the world [19][20][21], the structural validity is 0.81-0.92, and the Cronbach's coefficient of the total scale is 0.96. The Chinese version of BFI has been proven to have good reliability and validity [19].…”

Section: Primary Outcome Brief Fatigue Inventory-chinese Version (Bfimentioning

confidence: 99%

Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

et al. 2019

Preprint

“…According to the average score, it could be divided into 4 grades, that is no fatigue (score 0), mild fatigue (score 1-3), moderate fatigue (score 4-6), and severe fatigue (score 7-10). The BFI scale has been validated in different cancer patients all over the world [19][20][21], the structural validity is 0.81-0.92, and the Cronbach's coefficient of the total scale is 0.96. The Chinese version of BFI has been proven to have good reliability and validity [ 19].…”

Section: Primary Outcome Brief Fatigue Inventory-chinese Version (Bfimentioning

confidence: 99%

Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

et al. 2019

Preprint

Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.