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

Abstract 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.

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

Trials ◽

10.1186/s13063-019-3701-0 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Zhaoqin Wang ◽

Shanshan Li ◽

Luyi Wu ◽

Qin Qi ◽

Huirong Liu ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Primary Outcome ◽

Acupuncture Treatment ◽

Acupuncture Group ◽

Randomized Controlled ◽

Link Type ◽

Cancer Related Fatigue ◽

Secondary Outcomes

Abstract Background Fatigue 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/design This 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. Discussion This 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 registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

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Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2005.01.271 ◽

2005 ◽

Vol 23 (25) ◽

pp. 6027-6036 ◽

Cited By ~ 102

Author(s):

Patsy Yates ◽

Sanchia Aranda ◽

Maryanne Hargraves ◽

Bev Mirolo ◽

Alexandra Clavarino ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Randomized Controlled Trial ◽

Functional Assessment ◽

Controlled Trial ◽

Intervention Group ◽

Randomized Controlled ◽

Cancer Related Fatigue ◽

Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

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Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study (Preprint)

10.2196/preprints.31754 ◽

2021 ◽

Author(s):

Patrick Ware ◽

Amika Shah ◽

Heather Joan Ross ◽

Alexander Gordon Logan ◽

Phillip Segal ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Decision Support ◽

Chronic Conditions ◽

Controlled Trial ◽

Self Care ◽

Randomized Controlled ◽

Complex Patients ◽

Secondary Outcomes

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

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Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

Neurorehabilitation ◽

10.3233/nre-203207 ◽

2020 ◽

Vol 47 (4) ◽

pp. 451-462

Author(s):

Júlia Caetano Martins ◽

Sylvie Nadeau ◽

Larissa Tavares Aguiar ◽

Aline Alvim Scianni ◽

Luci Fuscaldi Teixeira-Salmela ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Post Intervention ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

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Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life

Annals of Oncology ◽

10.1093/annonc/mdu374 ◽

2014 ◽

Vol 25 (11) ◽

pp. 2237-2243 ◽

Cited By ~ 82

Author(s):

K. Steindorf ◽

M.E. Schmidt ◽

O. Klassen ◽

C.M. Ulrich ◽

J. Oelmann ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Randomized Controlled Trial ◽

Resistance Training ◽

Adjuvant Radiotherapy ◽

Controlled Trial ◽

Breast Cancer Patients ◽

Randomized Controlled ◽

Cancer Related Fatigue

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Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

10.21203/rs.2.12890/v4 ◽

2020 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Randomized Controlled ◽

Scale Total Score

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

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Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

10.21203/rs.2.12890/v3 ◽

2020 ◽

Author(s):

Ruimin Jiao ◽

Man Huang ◽

Weina Zhang ◽

Zhishun Liu

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Acne Vulgaris ◽

Sham Acupuncture ◽

Lesion Count ◽

Randomized Controlled ◽

Scale Total Score

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

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