Somatic acupressure for the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: A phase II randomized controlled trial.

OBJECTIVE: To evaluate the feasibility of the somatic acupressure (SA) for managing the fatigue-sleep disturbance-depression symptom cluster (FSDSC) among breast cancer (BC) survivors and its preliminary effects. METHODS: In this Phase II randomized controlled trial (RCT), 51 participants were randomised evenly into the true SA group, sham SA group, and usual care group. All the participants received usual care. The two SA groups performed additional true or sham self-acupressure daily for seven weeks. The primary outcomes related to the assessment of participants' recruitment and compliance with study questionnaires and interventions. Clinical outcomes assessed the preliminary effects of SA on fatigue, sleep disturbance, depression, and quality of life. Semi-structured interviews were undertaken to capture participants' experiences of participating in this study. The statistical effects of the intervention on the outcomes were modelled in repeated measures ANOVA and adjusted generalized estimating equations. RESULTS: Forty-five participants completed the SA intervention. No adverse events were reported. Over 85% of the participants could sustain for 25 days or more and 15 min or more per session, but the adherence to the intervention requirement was yet to improve. The group by time effect of the FSDSC and depression were significant (p < 0.05). Qualitative findings showed that participants positively viewed SA as a beneficial strategy for symptom management. CONCLUSIONS: The SA intervention protocol and the trial procedures were feasible. The results demonstrated signs of improvements in targeted outcomes, and a full-scale RCT is warranted to validate the effects of SA on the FSDSC.

Breathing Exercises for Pain Management in Cancer Survivors: A Systematic Review.

OBJECTIVES: Unmanaged pain significantly affects cancer survivors' quality of life. Nurses should play a significant role in pain management through non-pharmacological interventions. This review aims to explore the efficacy and safety of breathing exercises for pain management in all cancer survivors. DESIGN: A systematic review. DATA SOURCES: Thirteen databases, including PubMed, EMBase, CENTRAL, MEDLINE, CINAHL, JBI, Science Direct, Scopus, SocINDEX, Web of Science, PsycINFO, CNKI, and Wan Fang, were searched from inception to May, 2021. REVIEW/ANALYSIS METHODS: Studies that focused on the efficacy of breathing exercises for pain management, regardless of the age of the cancer survivors, were included. Cochrane tools were used for the quality appraisal of the included studies. Because of the limited number of studies, descriptive data analysis was used to summarize the results. RESULTS: Ten studies were included. Slow pursed lip breathing showed benefits for post-surgical pain. Contradictory findings were identified in the Enhanced Recovery After Surgery for post-surgical pain. Slow deep breathing and Hey-Hu regular breathing techniques were effective for pain management in pediatric cancer patients. The Active Cycle of Breathing Technique and five-minute mindful breathing did not have any statistically significant effects on pain relief. Quality of life was measured in three studies, with some improvement. Only one study addressed adverse events and reported that no adverse events occurred. CONCLUSIONS: Breathing exercises may be a promising approach to pain relief in cancer survivors. However, more rigorously designed studies are required to establish the evidence.

Development and Validation of an Evidence-Based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors.

BACKGROUND: Breathing exercise has been utilized as a promising approach to pain management in cancer survivors. However, the development process of the breathing exercise intervention protocol was rarely reported. AIM: To develop an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors and to provide a detailed account of the intervention development process. METHODS: The study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Intervention. The breathing exercise intervention development process adopted phase one of the Medical Research Council Framework for Developing and Evaluating Complex Intervention framework. The content validity index was applied to determine the consensus of the appropriateness of the breathing exercise intervention protocol among the panel experts. RESULTS: The preliminary breathing exercise intervention protocol was developed based on fight-or-flight theory and vagus nerve theory, and the best available research evidence identified from seven systematic reviews, three clinical trials, and four practice recommendations. The breathing exercise intervention was designed as slow deep pursed-lip breathing with a time ratio of inspiration to expiration 1:2-3. The intensity of the breathing exercise was determined as 3 to 5 sessions a day, 5 minutes per session, for 4 weeks. The content validity of the breathing exercise intervention protocol was excellent as consensus was achieved among all panel experts with both the item-level and scale-level CVIs reaching 1.0. CONCLUSIONS: This study developed an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors. The protocol is well-supported by the relevant theories, research evidence, practice recommendations, and experts' consensus.

Feasibility and potential effects of breathing exercise for chronic pain management in breast cancer survivors: study protocol of a phase II randomised controlled trial.

INTRODUCTION: Chronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective non-pharmacological interventions to improve chronic pain management, quality of life, anxiety and depression. Breathing exercise (BE) can be a promising option, but research evidence is sparse. This pilot study aims to examine the feasibility and preliminary effect of using an evidence-based BE intervention for chronic pain management in breast cancer survivors. METHOD AND ANALYSIS: This study will be a two-parallel-arm, open-labelled, phase II randomised controlled trial with 1:1 allocation. Seventy-two participants will be recruited from a tertiary hospital in China and randomly allocated to either a BE intervention group (n=36) or a control group (n=36). The participants in the intervention group will receive the usual care, a pain information booklet and a 4-week self-administered BE intervention; the participants in the control group will receive the usual care and the pain information booklet only. The assessment will be conducted at three time points: baseline (week 0), immediately after the intervention completion (week 5) and 4 weeks after the intervention completion (week 9). The primary outcomes will be the acceptability and feasibility assessment of the study protocol and methodological procedures. The secondary outcomes will be the effects of BE on pain, quality of life, anxiety and depression in breast cancer survivors. Descriptive statistics will be applied to present the primary outcomes and the Generalised Estimating Equation Model will be utilised to analyse the clinical outcomes. ETHICS AND DISSEMINATION: This study has received ethical approvals from the Human Research Ethics Committee at Charles Darwin University (H21089) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2022107). Findings from this study will be presented at academic conferences and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05257876.

The effect of an evidence-based Tai chi intervention on the fatigue-sleep disturbance-depression symptom cluster in breast cancer patients: A preliminary randomised controlled trial.

PURPOSE: To explore the potential effects of Tai chi on the fatigue-sleep disturbance-depression symptom cluster (FSDSC) among breast cancer (BC) patients. METHODS: This study was conducted as a preliminary randomized controlled trial among 72 BC patients (36 Tai chi and 36 control participants). All the participants were provided with routine care, while participants in the Tai chi group received an additional 8-week Tai chi intervention. Participants' fatigue, sleep disturbance and depression were assessed by the Brief Fatigue Inventory, the Pittsburgh Sleep Quality Index, and the Hospital Anxiety and Depression Scale-Depression. Participants' quality of life (QoL) was assessed by the Functional Assessment of Cancer Therapy-Breast. Both covariates-unadjusted and adjusted GEE models were run to assess the effects of Tai chi intervention on the FSDSC and QoL and the relevant impacts of the covariates. RESULTS: Sixty-nine participants completed this study. In the unadjusted GEE model, compared with the control group and baseline, participants in the Tai chi group showed significant reductions in fatigue (p < 0.001), sleep disturbance (p < 0.001) and depression (p = 0.006), as well as a significant improvement in QoL (p = 0.032) at immediately post-intervention and four-week follow-up. The positive regression coefficients of the adjusted GEE model showed fatigue, sleep disturbance and depression can have impacts on each other (all at p < 0.05). CONCLUSION: Tai chi as an adjuvant intervention to routine care could relieve the symptom cluster of fatigue, sleep disturbance and depression and improve QoL among BC patients.

Psychometric assessment of the Chinese version of the Oxford Knee Score in breast cancer survivors experiencing hormone treatment-related knee dysfunction.

Objective: To test the validity, reliability, and acceptability of the Oxford Knee Score (OKS) Mandarin Chinese version for measuring knee pain and function among Chinese breast cancer survivors. Methods: This validation study was a secondary analysis of a cross-sectional survey that was conducted at the Affiliated Hospital of Southwest Medical University, Sichuan, China. Recruited from a larger arthralgia-related survey cohort, those who experienced knee arthralgia and completed the OKS Chinese version were selected for the current analysis. The Cronbach's alpha coefficient was calculated to identify the internal consistency reliability of the OKS. Spearman's correlations were adopted to identify the concurrent validity of the OKS. The discriminate performance of the OKS via subgroup analysis of breast cancer survivors with or without arthritis, as well as different exercise levels, cancer stages, chemotherapy protocols, and occupations, was also conducted. Results: One hundred and fifty-nine breast cancer survivors were included. There were significant correlations between the OKS and the FACT-B, the SF-36, and the BPI in measuring knee pain symptoms and their impact on daily living activities. The Cronbach's alpha for the OKS total scores was 0.90. The participants with arthritis reported significantly lower OKS scores than those without arthritis (P â€‹= â€‹0.040). The difference in OKS total scores between the participants with different exercise levels (P â€‹< â€‹0.001) and the participants with different occupations (P â€‹= â€‹0.006) was statistically significant. Considerable ceiling effects (>15%) of the OKS Chinese version were found in 11 of 12 items. Conclusions: The OKS Mandarin Chinese version is a short, valid, reliable, and sensitive tool for knee pain and function assessment among breast cancer survivors.

Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial.

INTRODUCTION: The fatigue-sleep disturbance-depression (FSD) symptom cluster, as one of the most common symptom clusters in breast cancer (BC) survivors, can significantly decrease patients' quality of life. Since the management of the FSD symptom cluster has been unsatisfactory with the use of pharmacological treatments alone, non-pharmacological approaches have, therefore, been recommended. Somatic acupressure (SA) is a promising approach given its potential benefits of cancer-related symptom alleviation and the convenience of self-practice. However, research evidence on using acupressure to manage the FSD symptom cluster has been limited. The proposed trial aims to examine the feasibility and preliminary effects of an evidence-based SA intervention for FSD symptom cluster management in BC survivors. METHODS AND ANALYSIS: This study will be a phase II randomised controlled trial with three study arms and 1:1:1 allocation. Fifty-one early-stage BC survivors who are experiencing the FSD symptom cluster will be randomly assigned to a true SA group, a sham SA group or a usual care group. All participants will receive an education booklet regarding FSD symptom cluster management advice as the usual care package. The participants in the true SA group will additionally receive a 7-week self-administered SA intervention. The participants in the sham SA group will additionally receive self-administered light acupressure at non-acupoints with the same frequency, session and duration as the true SA group. The primary outcomes will be feasibility outcomes related to subject recruitment and completion of study questionnaires and interventions. The secondary outcomes will be the effects of SA on fatigue, sleep disturbance, depression and quality of life. Descriptive statistics will be used to present all the outcomes. The secondary outcomes will be analysed using an intent-to-treat approach. ETHICS AND DISSEMINATION: Ethical approvals of this trial have been granted by the Human Research Ethics Committee at Charles Darwin University (H19017) and the Clinical Trial Ethics Committee at The Affiliated Hospital of Southwest Medical University (KY2019039). Findings from this trial will be published in peer-reviewed journals and presented at professional conferences. TRIAL REGISTRATION NUMBER: This trial was registered at ClinicalTrials.gov and the registration number is NCT04118140, with the stage at Recruiting.

Massage Therapy for Fatigue Management in Breast Cancer Survivors: A Systematic Review and Descriptive Analysis of Randomized Controlled Trials.

BACKGROUND: Fatigue is one of the most common symptoms among breast cancer survivors. Although massage therapy has been commonly used for fatigue management, relevant evidence on the effectiveness of massage therapy for the reduction of fatigue in breast cancer survivors is still unclear. OBJECTIVE: To identify the research evidence on the effectiveness and safety of massage therapy to manage fatigue in breast cancer survivors and summarize the characteristics of massage therapy protocols utilized for fatigue management in breast cancer survivors. METHODS: Randomized controlled trials (RCTs) using massage therapy to manage cancer-related fatigue were searched in PubMed, Medline, Web of Science, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceDirect, PsycINFO, Wan Fang Data, and China National Knowledge Infrastructure (CNKI) from the inception of each database to March 2021. The Cochrane Back Review Group Risk of Bias Assessment Criteria was used to assess the methodological quality of the included studies. Descriptive analysis was applied for a summary and synthesis of the findings. The primary outcome was fatigue measured by any patient-reported questionnaires, and the secondary outcomes were quality of life and massage-therapy-related adverse events. RESULTS: Ten RCTs were included. Massage therapy was found to have a positive effect on fatigue management compared with routine care/wait list control groups and sham massage. Despite these encouraging findings, the review concluded that most of the included studies exhibited an unsatisfactory experimental design, particularly, inadequate blinding and allocation concealment. The duration and frequency of the massage therapy interventions varied across the studies. Adverse events were reported in three included studies, with no study conducting causality analysis. CONCLUSION: This systematic review provides the latest research evidence to support massage therapy as an encouraging complementary and alternative medicine approach to managing fatigue in breast cancer survivors. More rigorously designed, large-scale, sham-controlled RCTs are needed to further conclude the specific therapeutic effectiveness and safety issues of massage therapy for fatigue management.

Traditional Chinese exercise for cancer-related sleep disturbance: A systematic review and descriptive analysis of randomized controlled trials.

BACKGROUND: Traditional Chinese exercise (TCE) has been found to be an effective and convenient treatment for cancer-related sleep disturbance. This study aimed to summarize and assess the effects of TCE on cancer-related sleep disturbance. METHODS: Randomized controlled trials utilizing TCE for managing cancer-related sleep disturbance were searched in 11 databases. The primary outcome was sleep quality measured by various patient-reported scales, and the secondary outcome was TCE-related adverse events. Descriptive analysis was adopted for outcome assessment. RESULTS: Ten studies and three ongoing trials were included. TCE had a significantly positive effect on sleep outcomes compared with usual care. However, contradictory findings were reported when comparing TCE with other exercises and a sham intervention. CONCLUSION: This study supported a potentially beneficial role of TCE in alleviating cancer-related sleep disturbance. More rigorously designed sham-controlled studies are necessary to further explore the role of TCE in managing cancer-related sleep disturbance.

Somatic Acupoint Stimulation for Cancer-Related Sleep Disturbance: A Systematic Review of Randomized Controlled Trials.

AIM: The aim of this systematic review was to analyze and synthesize available evidence for the effects of somatic acupoint stimulation (SAS) on cancer-related sleep disturbance in adults with cancer. METHODS: Nine databases and four clinical trial registries were searched from their inception to July 2019 to identify potential articles and registered trials. Two authors independently extracted data and appraised the methodological quality of the included studies. The included studies could not be subjected to meta-analysis due to the significant variations in SAS intervention protocols and outcome measurement instruments. This systematic review therefore reported the results of the included trials narratively. RESULTS: Seven studies were identified, which involved 906 cancer patients. SAS protocols varied across trials without an optimal evidence-based standard intervention protocol to manage cancer-related sleep disturbance. Sanyinjiao (SP6) was the most commonly selected acupoint. Manual acupuncture was typically 15-30 min in duration and was conducted once a day or once a week for a period of 1-5 weeks, whereas self-administered acupressure was typically 1-3 min in duration per point and was conducted once a day, such as during night time before going to bed, for a period of 1-5 months. The results indicated that SAS could potentially relieve cancer-related sleep disturbance and improve quality of life. Mild adverse effects were reported in three of the included studies, but none of them performed a causality analysis to clarify the association between the reported adverse events and the intervention. CONCLUSIONS: This systematic review showed that SAS is a useful approach to relieving cancer-related sleep disturbance. However, research evidence on SAS for managing cancer-related sleep disturbance has not been fully conclusive due to the limited number of existing clinical studies with relatively small sample size and suboptimal methodological quality. Clinical trials with large sample size and robust methodology are warranted in future research.

Acupuncture-Point Stimulation for Postoperative Pain Control: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

The purpose of this study was to evaluate the effectiveness of Acupuncture-point stimulation (APS) in postoperative pain control compared with sham/placebo acupuncture or standard treatments (usual care or no treatment). Only randomized controlled trials (RCTs) were included. Meta-analysis results indicated that APS interventions improved VAS scores significantly and also reduced total morphine consumption. No serious APS-related adverse effects (AEs) were reported. There is Level I evidence for the effectiveness of body points plaster therapy and Level II evidence for body points electroacupuncture (EA), body points acupressure, body points APS for abdominal surgery patients, auricular points seed embedding, manual auricular acupuncture, and auricular EA. We obtained Level III evidence for body points APS in patients who underwent cardiac surgery and cesarean section and for auricular-point stimulation in patients who underwent abdominal surgery. There is insufficient evidence to conclude that APS is an effective postoperative pain therapy in surgical patients, although the evidence does support the conclusion that APS can reduce analgesic requirements without AEs. The best level of evidence was not adequate in most subgroups. Some limitations of this study may have affected the results, possibly leading to an overestimation of APS effects.