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Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

ABSTRACT: Introduction:Rice bran arabinoxylan compound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine profile, and gut microbiota. Methods/Design:The study will recruit 50 participants from a regional cancer center in Australia. Patients aged 18-70, diagnosed with solid organ cancers stage II and above, and currently undergoing active systemic therapies, are eligible. Random allocation of participants into two groups is stratified based on metastatic status and treatment type. The dosage is either 3 g/day of RBAC or placebo in identical packaging. The participants, study coordinator, and treating oncologists are blinded to the interventions. Data collections are at baseline and at four follow-up sessions, which are six weeks apart (24 weeks). Statistical analysis will involve a protected p-value with multiple dependent values and analyzed by ANOVA with repeated measures on the occasion of testing and with both a full Bonferroni or Sidak corrections applied to protect against Type I errors. Any observed significance warrants further analysis with pairwise comparisons. Analysis of covariance will also be performed to assess any influence of the demographic data, cancer diagnosis, as well as changes in physical activity, dietary habits, and complementary medicine usage. Comparisons of gut microbiota will be based on the analysis of the fecal microbiome using 16S ribosomal ribonucleic acid amplicon sequencing. The proposed research timeline is from October 2018 to May 2022. Trial registration:ANZCTR. Reg No: ACTRN12619000562178p.

SUBMITTER: Ooi SL

PROVIDER: S-EPMC7284132 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

Ooi Soo Liang SL Pak Sok Cheon SC Micalos Peter S PS Schupfer Emily E Zielinski Rob R Jeffries Thomas T Jeffries Thomas T Harris Garth G Golombick Terry T McKinnon David D

Contemporary clinical trials communications 20200529

<h4>Introduction</h4>Rice bran arabinoxylan compound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine profile, and gut microbiota.<h4>Methods/design</h4>The study will recruit 50 p ...[more]

PMID: 32548333

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Project description:BackgroundThe Swallowing Quality-of-Life Questionnaire (SWAL-QoL) is considered the gold standard for assessing health-related QoL in oropharyngeal dysphagia. The Dutch translation (DSWAL-QoL) and its adjusted version (aDSWAL-QoL) have been validated using classical test theory (CTT). However, these scales have not been tested against the Rasch measurement model, which is required to establish the structural validity and objectivity of the total scale and subscale scores. Thus, the purpose of this study was to examine the psychometric properties of these scales using item analysis according to the Rasch model.MethodsItem analysis with the Rasch model was performed using RUMM2030 software with previously collected data from a validation study of 108 patients. The assessment included evaluations of overall model fit, reliability, unidimensionality, threshold ordering, individual item and person fits, differential item functioning (DIF), local item dependency (LID) and targeting.ResultsThe analysis could not establish the psychometric properties of either of the scales or their subscales because they did not fit the Rasch model, and multidimensionality, disordered thresholds, DIF, and/or LID were found. The reliability and power of fit were high for the total scales (PSI = 0.93) but low for most of the subscales (PSI < 0.70). The targeting of persons and items was suboptimal. The main source of misfit was disordered thresholds for both the total scales and subscales. Based on the results of the analysis, adjustments to improve the scales were implemented as follows: disordered thresholds were rescaled, misfit items were removed and items were split for DIF. However, the multidimensionality and LID could not be resolved. The reliability and power of fit remained low for most of the subscales.ConclusionsThis study represents the first analyses of the DSWAL-QoL and aDSWAL-QoL with the Rasch model. Relying on the DSWAL-QoL and aDSWAL-QoL total and subscale scores to make conclusions regarding dysphagia-related HRQoL should be treated with caution before the structural validity and objectivity of both scales have been established. A larger and well-targeted sample is recommended to derive definitive conclusions about the items and scales. Solutions for the psychometric weaknesses suggested by the model and practical implications are discussed.

Project description:BACKGROUND: Phenylketonuria (PKU) is a chronic inborn error of amino acid metabolism that requires lifelong follow-up and intervention, which may represent strains on Quality of Life (QoL). This observational study evaluated QoL in a cohort of PKU patients, using updated and detailed instruments. METHODS: 22 patients with mild PKU respondent to BH4 and 21 patients with classical PKU treated with diet were recruited in this study. Adult patients completed WHOQOL questionnaire-100 (WHOQOL-100) and pediatric patients the Pediatric QoL inventory (PedsQL(TM)). Psychiatric and mood disorders were also evaluated using TAD or BDI and STAI-Y inventories. A multivariable linear regression model was fitted to investigate the predictors of QoL, including age, sex, treatment type, length of current treatment, educational level and employment status (only for adults) as covariates. Results were presented as regression coefficients with 95% confidence interval. RESULTS: Global QoL scores were within normal range both in patients with mild and classical disease but global QoL scores were significantly higher in patients with mild PKU under BH4 treatment as compared to those affected by classical disease who were under diet regimen. Furthermore, QoL significantly increased in long treated PKU patients. Among adult patients, QoL scores were significantly lower in males, in patients with lower education and in those employed or unemployed as compared to students (baseline). CONCLUSIONS: Both diet and medical treatment based upon BH4 seem to be associated with higher QoL in the long run. However, patients with mild PKU can rely on BH4 to achieve a higher Phe tolerance and a better compliance to therapy due to diet relaxation/avoidance. Some specific categories of patients with a lower QoL should be investigated more in depth, engaging with those at risk of lower treatment compliance. The questionnaires employed in the present study seemed to be able to effectively detect criticalities in QoL assessment and represent an advance from previous inventories employed in the past.

Dataset Information

Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

Publications

Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

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