Acupuncture for Pain and Dysfunction After Neck Dissection: Results of a Randomized Controlled Trial

Purpose To determine whether acupuncture reduces pain and dysfunction in patients with cancer with a history of neck dissection. The secondary objective is to determine whether acupuncture relieves dry mouth in this population. Patients and Methods Patients at a tertiary cancer center with chronic pain or dysfunction attributed to neck dissection were randomly assigned to weekly acupuncture versus usual care (eg, physical therapy, analgesia, and/or anti-inflammatory drugs, per patient preference or physician recommendation) for 4 weeks. The Constant-Murley score, a composite measure of pain, function, and activities of daily living, was the primary outcome measure. Xerostomia, a secondary end point, was assessed using the Xerostomia Inventory. Results Fifty-eight evaluable patients were accrued and randomly assigned from 2004 to 2007 (28 and 30 patients on acupuncture and control arms, respectively). Constant-Murley scores improved more in the acupuncture group (adjusted difference between groups = 11.2; 95% CI, 3.0 to 19.3; P = .008). Acupuncture produced greater improvement in reported xerostomia (adjusted difference in Xerostomia Inventory = –5.8; 95% CI, –0.9 to –10.7; P = .02). Conclusion Significant reductions in pain, dysfunction, and xerostomia were observed in patients receiving acupuncture versus usual care. Although further study is needed, these data support the potential role of acupuncture in addressing post–neck dissection pain and dysfunction, as well as xerostomia.

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The Effect of Therapeutic Touch on Pain and Fatigue of Cancer Patients Undergoing Chemotherapy

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nen006 ◽

2010 ◽

Vol 7 (3) ◽

pp. 375-381 ◽

Cited By ~ 45

Author(s):

Nahid Aghabati ◽

Eesa Mohammadi ◽

Zahra Pour Esmaiel

Keyword(s):

Usual Care ◽

Cancer Patients ◽

Usual Care Group ◽

Therapeutic Touch ◽

Cancer Center ◽

Care Group ◽

Pharmacological Interventions ◽

Patients With Cancer ◽

Before And After ◽

And Control

Despite major advances in pain management, cancer pain is managed poorly in 80% of the patients with cancer. Due to deleterious side effects of pharmacology therapy in these people, there is an urgent need for clinical trials of non-pharmacological interventions. To examine the effect of therapeutic touch (TT) on the pain and fatigue of the cancer patients undergoing chemotherapy, a randomized and three-groups experimental study—experimental (TT), placebo (placebo TT), and control (usual care)—was carried out. Ninety patients undergoing chemotherapy, exhibiting pain and fatigue of cancer, were randomized into one of the three groups in the Cancer Center of Imam Khomeini Hospital in Tehran, Iran. Pain and fatigue were measured and recorded by participants before and after the intervention for 5 days (once a day). The intervention consisted of 30 min TT given once a day for 5 days between 10:00 a.m. and 10:30 a.m. The Visual Analogue Scale (VAS) of pain and the Rhoten Fatigue Scale (RFS) were completed for 5 days before and after the intervention by the subjects. The TT (significant) was more effective in decreasing pain and fatigue of the cancer patients undergoing chemotherapy than the usual care group, while the placebo group indicated a decreasing trend in pain and fatigue scores compared with the usual care group.

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Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial

10.1101/2021.08.13.21261969 ◽

2021 ◽

Author(s):

Steven Lubitz ◽

Steven J. Atlas ◽

Jeffrey M. Ashburner ◽

Ana Lipsanopoulos ◽

Leila Borowsky ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Usual Care ◽

Controlled Trial ◽

Oral Anticoagulants ◽

Care Practice ◽

Control Group ◽

Newly Diagnosed ◽

One Year ◽

And Control

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥ 65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16,0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18,3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01,0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5,10.4). Conclusions: Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation.

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A community-based randomized trial for the prevention and control of brucellosis among rural populations in Iran: application of the PRECEDE planning model

10.21203/rs.2.13991/v2 ◽

2020 ◽

Author(s):

Leila Jahangiry ◽

Maryam Khazaee-Pool ◽

Towhid Babazadeh ◽

Parvin Sarbakhsh ◽

Koen Ponnet

Keyword(s):

Prevention And Control ◽

Intervention Program ◽

Controlled Trial ◽

Animal Health ◽

Public Health Problem ◽

Control Program ◽

Control Group ◽

Community Based ◽

History Of ◽

And Control

Abstract Background: Brucellosis is one of the most frequently occurring zoonotic diseases of veterinary and a public health problem in developing countries. It affects human and animal health and has measurable effects on the productive and reproductive performance of livestock. Therefore, the main purpose of this study was to develop a community-based intervention program for brucellosis prevention and control. A two-arm parallel cluster randomized controlled trial investigated the effectiveness of the program over six months in a rural population in Ahar, East Azerbaijan, Iran. A total of 16 village health houses were randomly allocated to the intervention and the control groups (eight per arm), and 400 participants were recruited via household health records in the health houses. The PRECEDE model, which is an acronym for Predisposing, Reinforcing and Enabling Constructs in Educational Diagnosis and Evaluation, was used to design, implement, and evaluate the brucellosis prevention and control program. Knowledge, attitudes, self-efficacy, social support, environmental enabling, and behavioral factors were measured at the baseline and the six-month follow-up. A generalized mixed effects model was used to analyze data. Results: The mean ages (SD) of the intervention and control group respondents were 35.9 (11.87) and 37.28 (11.04) years, respectively. After the six-month intervention, significant between-group differences were found on all PRECEDE variables, adjusted for education, history of brucellosis, and family history of brucellosis. Conclusion: There is a need to consolidate collaborative health and veterinary sector efforts, as well as increase regular vaccination practices and financial resources to support farmers willing to slaughter animals and/or offer slaughter facilities. The present study was able to demonstrate which educational and ecological factors influence behaviors and environments related to brucellosis and, as such, provide evidence of the effectiveness of interventions based on the PROCEDE model.

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Gemcitabine-related thrombocytosis: Does it increase the risk of thrombosis?

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.6091 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 6091-6091

Author(s):

S. Ahmed ◽

R. K. Shahid ◽

A. Sami ◽

S. Yadav ◽

I. Ahmad ◽

...

Keyword(s):

Platelet Count ◽

Median Number ◽

Vascular Event ◽

Cancer Center ◽

Platinum Compound ◽

Advanced Malignancy ◽

Exact Test ◽

Patients With Cancer ◽

Increased Risk ◽

History Of

6091 Background: Gemcitabine is an antimetabolite agent that has demonstrated activity in various solid and hematological malignancies. Although thrombocytopenia is a known side effect, gemcitabine-related thrombocytosis has been uncommonly reported. Chemotherapy increases the risk of thrombo-embolism in patients with cancer. The study aimed to identify the incidence of gemcitabine-related thrombocytosis and to determine whether it has been associated with an increased risk of thrombo-embolism. Methods: Medical records of 175 consecutive adults patients with a malignant disease who received gemcitabine at Saskatoon Cancer Center were reviewed. Patients with history of prior thrombo-embolism or with baseline thrombocytosis were excluded. Fisher’s Exact test was done for statistical analysis. Results: 149 eligible patients with median age of 62 (26–83) and M:F of 1.01:1 were identified. 141 (95%) patients had advanced malignancy and 61 (41%) had received prior chemotherapy. 106 (71%) patients received combination of chemotherapy and 95% of those patients received gemcitabine in combination with a platinum compound. Median number of cycle was 3 (1–8). Median platelets count prior to commencement of gemcitabine was 285 × 109 (44–449). 83 (56%) patients experienced thrombocytopenia whereas 69 (46%) patients experienced thrombocytosis within 3 weeks of treatment with gemcitabine. Median post-gemcitabine platelet count in patients with thrombocytosis was 622 × 109 (457–1385). 15 (10%) patients experienced thrombocytosis with each cycle of gemcitabine. Median duration of thrombocytosis was 2 weeks (0.5−5). 13 (9%) of 149 patients experienced a vascular event (venous, n=9; arterial, n=4) within 6 weeks of treatment with gemcitabine. Median platelet count prior to the vascular event was 268 × 109 (79–669). All except one patient had advanced malignancy and 85% had received combination of chemotherapy. 5 of 69 (7%) patients with thrombocytosis experienced a vascular event compared with 8 of 80 (10%) patients without thrombocytosis (p=0.77). Conclusions: Gemcitabine has been associated with an increased incidence of thrombocytosis. However gemcitabine-related thrombocytosis is a transient phenomenon and has not been associated with an increased risk of a vascular event. No significant financial relationships to disclose.

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Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial (Preprint)

10.2196/preprints.16462 ◽

2019 ◽

Author(s):

Maria Lazo-Porras ◽

Antonio Bernabe-Ortiz ◽

Alvaro Taype-Rondan ◽

Robert H. Gilman ◽

German Malaga ◽

...

Keyword(s):

Diabetic Foot ◽

Controlled Trial ◽

Risk Groups ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Foot Care ◽

History Of ◽

Control Instruction ◽

Study Participants ◽

And Control

BACKGROUND Thermometry monitoring has proven to reduce the occurrence of diabetic foot ulcers (DFU). mHealth may contribute to enhance adherence to this effective intervention. OBJECTIVE Our objective was to compare incidence of DFU in the thermometry plus mHealth reminders intervention arm vs. thermometry-only control arm. METHODS We conducted a randomized trial enrolling adults with type 2 diabetes mellitus with foot-at-risk (risk groups 2 or 3) without foot ulcers and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or to intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. RESULTS A total of 172 patients (63% women, mean age 61 years) were enrolled, 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the HR for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants that returned the logbook, without difference between intervention and control arm. CONCLUSIONS This trial contributes to the evidence about the value of mHealth to prevent diabetes foot ulcers. CLINICALTRIAL Clinical trials, NCT02373592. Registered 27 February 2015, https://clinicaltrials.gov/ct2/show/NCT02373592

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Beating Adolescent Self-Harm (BASH): a randomised controlled trial comparing usual care versus usual care plus a smartphone self-harm prevention app (BlueIce) in young adolescents aged 12–17 who self-harm: study protocol

BMJ Open ◽

10.1136/bmjopen-2021-049859 ◽

2021 ◽

Vol 11 (11) ◽

pp. e049859

Author(s):

Isobel Greenhalgh ◽

Jessica Tingley ◽

Gordon Taylor ◽

Antonieta Medina-Lara ◽

Shelley Rhodes ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Health Service ◽

Usual Care ◽

Controlled Trial ◽

South Central ◽

History Of ◽

Self Harm ◽

Randomised Controlled ◽

Utilisation Data

IntroductionA mobile app, BlueIce, was codesigned with young people with a history of self-harm to provide them with more accessible and available evidence-based support at times of distress. A preliminary evaluation found that BlueIce was acceptable, safe and used by young people and helped to reduce self-harm. The present study is designed to assess the effectiveness and cost-effectiveness of adding BlueIce to usual Child and Adolescent Mental Health Service (CAMHS).Methods and analysisThis study is a single-blind, randomised controlled trial comparing usual CAMHS care with usual care plus BlueIce. A total of 138 adolescents aged 12–17 with current or a history of self-harm will be recruited through the Oxford Health National Health Service (NHS) Foundation Trust via their CAMHS clinician. The primary outcome is self-harm at 12 weeks assessed using the Risk Taking and Self-Harm Inventory for Adolescents. Secondary outcomes include mood, anxiety, hopelessness, general behaviour, sleep and impact on everyday life at 12 weeks and 6 months. Health-related quality of life and healthcare resource utilisation data will be collected at baseline, 12 weeks and 6 months. Postuse interviews at 12 weeks will determine the acceptability, safety and usability of BlueIce.Ethics and disseminationThe study was approved by the NHS South Central—Oxford B NHS Research Ethics Committee (19/SC/0212) and by the Health Research Authority (HRA) and Health and Care Research Wales. Findings will be disseminated in peer review open-access journals and at academic conferences.Trial registration numberISRCTN10541045.

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Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students (Preprint)

10.2196/preprints.11349 ◽

2018 ◽

Author(s):

Lorna Cook ◽

Mohammod Mostazir ◽

Edward Watkins

Keyword(s):

University Students ◽

Usual Care ◽

Behavioral Therapy ◽

Controlled Trial ◽

Primary Objective ◽

Effect Sizes ◽

Phase Iii ◽

Web Based ◽

Randomized Controlled ◽

Secondary Objective

BACKGROUND Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. OBJECTIVE The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. METHODS To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. RESULTS Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. CONCLUSIONS Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. CLINICALTRIAL ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX) INTERNATIONAL REGISTERED REPOR RR2-10.1186/s13063-015-1128-9

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Three-field versus two-field lymphadenectomy for carcinoma of the middle and lower esophagus: Short-term results of a randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.4036 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 4036-4036

Author(s):

Bin Li ◽

Haiquan Chen

Keyword(s):

Lymph Nodes ◽

Tumor Staging ◽

Controlled Trial ◽

Group Versus ◽

Tumor Location ◽

Cancer Center ◽

Lower Esophagus ◽

Patients With Cancer ◽

Field Versus ◽

Significant Difference

4036 Background: The safety and efficacy of esophagectomy with 3-field lymphadenectomy remain controversial. Methods: We did this randomized trial in Fudan University Shanghai Cancer Center in China. Between March 2013 and November 2016, 400 patients with cancer located in the middle and lower esophagus were recruited and randomly assigned to receive 3-field or 2-field lymphadenectomy at a 1:1 ratio. Postoperative complications between the 3-field group (n = 200) and 2-field group (n = 200) were compared on the basis of the intention-to-treatment principle. Results: There was no significant difference between the two arms in terms of gender, age, BMI, FEV1, and tumor location. Median operative time was 183 minutes (range 125 to 331) in 3-field group versus 168 minutes (range 116 to 375) in 2-field group, P< 0.001. Overall morbidity was 28% (56/200) in the 3-field group and 30.5% (61/200) in the 2-field group, P= 0.583. The mortality rate was 0% (0/200) for the 3-field group and 0.5% (1/200) for the 2-field group, P= 1.000. Although more reintubation occurred in the 3-field group than in the 2-field group (3% [6/200] vs. 0% [0/200], P= 0.030), the distribution of severity (stratified according to the Clavien-Dindo classification) and hospital stay were similar between the two groups. A significantly higher number of lymph nodes were retrieved in the 3-field group (median 37, range 3 to 85) compared to those in the 2-field group (median 24, range 7 to 61) ( P< 0.001). 44 patients (22%) had positive cervical nodes in the 3-field group. Conclusions: Morbidity after esophagectomy with 3-field lymphadenectomy is comparable with that after 2-field lymphadenectomy. Cervical lymphatic involvement is common in patients with middle and lower esophageal cancer. 3-field lymphadenectomy may offer more accurate tumor staging related to cervical lymphatic metastasis. TABLE. Regions of lymph nodes metastases Clinical trial information: NCT01807936. [Table: see text]

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Effect of oligofructose supplementation on body weight in overweight and obese children: a randomised, double-blind, placebo-controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114514003110 ◽

2014 ◽

Vol 112 (12) ◽

pp. 2068-2074 ◽

Cited By ~ 26

Author(s):

Anna Liber ◽

Hania Szajewska

Keyword(s):

Body Weight ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Obese Children ◽

Double Blind ◽

Body Weight Reduction ◽

Score Difference ◽

The Difference ◽

Total Body ◽

And Control

Limited evidence suggests that the dietary inclusion of oligofructose, an inulin-type fructan with prebiotic properties, may increase satiety and, thus, reduce energy intake and body weight in overweight and obese adults. The aim of the present study was to assess the effect of oligofructose supplementation for 12 weeks on the BMI of overweight and obese children. A total of ninety-seven children aged 7–18 years who were overweight and obese (BMI >85th percentile) were randomly assigned to receive placebo (maltodextrin) or oligofructose (both at an age-dependent dose: 8 g/d for children aged 7–11 years and 15 g/d for children aged 12–18 years) for 12 weeks. Before the intervention, all children received dietetic advice and they were encouraged to engage in physical activity. The primary outcome measure was the BMI-for-age z-score difference between the groups at the end of the intervention. Data from seventy-nine (81 %) children were available for analysis. At 12 weeks, the BMI-for-age z-score difference did not differ between the experimental (n 40) and control (n 39) groups (mean difference 0·002, 95 % CI − 0·11, 0·1). There were also no significant differences between the groups with regard to any of the secondary outcomes, such as the mean BMI-for-age z-score, percentage of body weight reduction and the difference in total body fat. Adverse effects were similar in both groups. In conclusion, oligofructose supplementation for 12 weeks has no effect on body weight in overweight and obese children.

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Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2015.63.0830 ◽

2016 ◽

Vol 34 (6) ◽

pp. 557-565 ◽

Cited By ~ 758

Author(s):

Ethan Basch ◽

Allison M. Deal ◽

Mark G. Kris ◽

Howard I. Scher ◽

Clifford A. Hudis ◽

...

Keyword(s):

Usual Care ◽

Cancer Care ◽

Patient Reported Outcomes ◽

Controlled Trial ◽

Intervention Group ◽

Cancer Center ◽

Symptom Monitoring ◽

Outpatient Chemotherapy ◽

Patient Reported ◽

E Mail

Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited. Methods We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival. Results Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts. Conclusion Clinical benefits were associated with symptom self-reporting during cancer care.

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