Effects of Laser Acupuncture on Constipation in Patients With Advanced Cancer: Study Protocol for a Double-blinded, Randomized Controlled Trial

2021 ◽  
Author(s):  
Jen-Ming Chen ◽  
Chao-Tung Chen ◽  
Bei-Yu Wu ◽  
Yung-Hsiang Chen ◽  
Chun-Ting Liu
Keyword(s):  
Randomized Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Colonic Motility ◽  
Analysis Of Covariance ◽  
Laser Acupuncture ◽  
Advanced Cancer Patients ◽  
Chi Square ◽  
Randomized Controlled ◽  
Double Blinded

Abstract BackgroundConstipation is a common, uncomfortable, and frustrating complication in patients with advanced cancer which in turn affects the patient’s quality of life. The aim of this study is to investigate the effects of laser acupuncture on constipation.MethodsThis is a prospective, single-center, double-blinded, randomized controlled trial study. A sample of 74 participants will be randomly assigned to either the verum or the sham laser acupuncture group in a 1:1 ratio. The participants will receive laser acupuncture or sham laser acupuncture once a day for consecutive six days on eight acupoints (LI4, LI11, PC6, ST36, ST37, ST39, SP4, and SP9). The number of complete spontaneous bowel will be used primarily for the evaluation, and symptoms of constipation, comfort levels during defecation, and colonic motility will be also be measured. Data will be analyzed using the chi-square test or t-test. Analysis of covariance will be used to examine the differences on symptoms of constipation between two groups and adjusted for their respective baseline levels. DiscussionThis trial may provide evidence for improving the short-term benefit for advanced cancer patients by relieving the symptoms caused by constipation. As a result, further reduce the usage of medications, and lower the side effects due to medications.Trial registration: ClinicalTrials.gov, NCT04318808. Registered on 24 March 2020.

Advanced cancer patients’ reported wishes at the end of life: a randomized controlled trial

2016 ◽  
Vol 24 (10) ◽  
pp. 4273-4281 ◽  
Author(s):  
Marvin O. Delgado-Guay ◽  
Alfredo Rodriguez-Nunez ◽  
Vera De la Cruz ◽  
Susan Frisbee-Hume ◽  
Janet Williams ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
End Of Life ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Advanced Cancer Patients ◽  
Randomized Controlled

scholarly journals Lessons learned from a randomized controlled trial on a home delivered meal service in advanced cancer patients undergoing chemotherapy: a pilot study

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Vera IJmker-Hemink ◽  
Nora Lize ◽  
Sandra Beijer ◽  
Natasja Raijmakers ◽  
Geert Wanten ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Missing Values ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Lessons Learned ◽  
Advanced Cancer Patients ◽  
Randomized Controlled ◽  
Meal Service

Abstract Background Performing a randomized controlled trial (RCT) in the field of nutrition is challenging and success highly depends on understanding the factors that influence recruitment and dropout of participants. Our aim was to assess the feasibility of a RCT that evaluated a home delivered meal service in advanced cancer patients while receiving chemotherapy. Methods This pilot RCT aimed to enroll 20 participants who were randomized into the home delivered meal service group or usual care group. Study procedures took place before chemotherapy (T0), 3 weeks after T0 (T1), 6 weeks after T0 (T2) and 3 months after T2 (T3). All information regarding recruitment, dropout and study procedures was recorded. Patient satisfaction was assessed by in-depth interviews. Results Over 7 months, 20 of 41 approached patients (49%) were included, followed by a dropout rate of 35%. At baseline, hand grip strength (n = 8/16), the Short Physical Performance Battery (n = 12/16) and nutritional intake (n = 8/16) had the highest rate of missing values. Study procedures were not experienced as burdensome and planning of these procedures in line with fixed hospital appointments contributed to this low burden. Keeping the symptom diary was mentioned as being burdensome. Conclusions It is feasible to conduct a RCT on a home delivered meal service in advanced cancer patients during chemotherapy, although recruitment is challenging. Close contact of patients with recruiting personnel is essential to sustain motivation. To increase compliance with the study protocol it is important to carefully instruct participants on how to complete questionnaires and to emphasize to use these in the communication with their practitioners. Trial registration ClinicalTrials.gov NCT03382171.

scholarly journals Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer

2018 ◽  
Vol 36 (23) ◽  
pp. 2422-2432 ◽  
Author(s):  
Gary Rodin ◽  
Christopher Lo ◽  
Anne Rydall ◽  
Joanna Shnall ◽  
Carmine Malfitano ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
End Of Life ◽  
Advanced Cancer ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Comprehensive Cancer Center ◽  
Randomized Controlled ◽  
End Point

Purpose Individuals with advanced cancer experience substantial distress in response to disease burden and impending mortality. Managing Cancer And Living Meaningfully (CALM) is a novel, brief, manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. We conducted a randomized controlled trial to compare CALM with usual care (UC) in this population. Methods Patients with advanced cancer were recruited from outpatient oncology clinics at a comprehensive cancer center into an unblinded randomized controlled trial. Permuted block randomization stratified by Patient Health Questionnaire-9 depression score allocated participants to CALM plus UC or to UC alone. Assessments of depressive symptoms (primary outcome), death-related distress, and other secondary outcomes were conducted at baseline, 3 months (primary end point), and 6 months (trial end point). Analyses were by intention to treat. Analysis of covariance was used to test for outcome differences between groups at follow-up, controlling for baseline. Mixed-model results are reported. Results Participants (n = 305) were recruited between February 3, 2012, and March 4, 2016, and randomly assigned to CALM (n = 151) or UC (n = 154). CALM participants reported less-severe depressive symptoms than UC participants at 3 months (Δ = 1.09; P = .04; Cohen’s d = 0.23; 95% CI, 0.04 to 2.13) and at 6 months (Δ = 1.29; P = .02; d = 0.29; 95% CI, 0.24 to 2.35). Significant findings for greater end-of-life preparation at 6 months also favored CALM versus UC. No adverse effects were identified. Conclusion Findings suggest that CALM is an effective intervention that provides a systematic approach to alleviating depressive symptoms in patients with advanced cancer and addresses the predictable challenges these patients face.

scholarly journals A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Thamires Monteiro do Carmo ◽  
Bianca Sakamoto Ribeiro Paiva ◽  
Milena Ruas de Siqueira ◽  
Luciana de Toledo Bernardes da Rosa ◽  
Cleyton Zanardo de Oliveira ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Phase Ii Study ◽  
Controlled Trial ◽  
Trial Protocol ◽  
Advanced Cancer Patients ◽  
Randomized Controlled ◽  
Protocol Study
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