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Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial.

ABSTRACT: Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. This single-arm preliminary pilot study aims to explore the effects of a six-month early intervention program following reconstructive surgery in oral cancer survivors.A total of 65 participants were analyzed following reconstructive surgery. Outcome measurements were taken during the first visit, and at one, three and six months after reconstructive surgery.Scapular muscle strength and shoulder range of motion progressively improved during the 6-month follow-up. The mean Disability of the Arms, Shoulder and Hand (DASH) score showed significant improvement at 1 month (p < .001). Health related QoL showed significant differences between baseline and 6-months post-surgery scores on global health and on most of the function and symptom scales. The predicted return-to-work rate was 80% at one year after the operation. Return-to-work rate differs in different vocational types, with a higher rate of return in the skilled or semi-skilled (87.5%) and self-employed (86.7%).We suggest that early integrated intervention program with a follow-up of at least six months following reconstructive surgery may help develop and identify intervention guidelines and goals in the initial six months of treatment following neck dissection in oral cancer survivors.

SUBMITTER: Chen YH

PROVIDER: S-EPMC5827017 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial.

Chen Yueh-Hsia YH Liang Wei-An WA Hsu Chung-Yin CY Guo Siang-Lan SL Lien Shwu-Huei SH Tseng Hsiao-Jung HJ Chao Yuan-Hung YH

PeerJ 20180221

<h4>Background</h4>Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. This single-arm preliminary pilot study aims to explore the effects of a six-month early intervention program following reconstructive surgery in oral cancer survivors.<h4>Methods</h4>A total of 65 participants were analyzed following reconstructive surgery. Outcome measur ...[more]

PMID: 29492348

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Project description:BackgroundQuality of life outcomes have been used frequently in clinical trials of oral health interventions. This study assessed the effects of a randomized trial on oral health related quality of life comparing an individual-based oral hygiene intervention to a community-based intervention.MethodsParticipants were recruited from six low-income senior housing residences. Buildings were randomly assigned to receive the individual-based intervention followed by the community-based intervention or to receive the community-based intervention followed by the individual intervention. Participants' oral hygiene was assessed at baseline (T0), one month after the first intervention (T1) and one month after the second intervention (T2) and six months after the T2 assessment (T3). Oral hygiene was measured by the Gingival Index (GI) and Plaque scores (PS). Surveys collected data on beliefs, attitudes, behaviors and self-reported health status at T0, T1 and T2. Only oral hygiene and quality of life, measured by the General Oral Health Assessment Index (GOHAI), was assessed at all time points. general linear mixed models (GLMM) were used to assess changes in GOHAI over time, the interaction of condition by time and the contribution of psychosocial, behavioral, health status and background variables to changes in GOHAI.Results331 people completed T0 assessments; 306 completed T1; 285 completed T2 and 268 completed T3. Scores on GOHAI at T0 ranged from 10 to 48 with a mean of 39.7 (sd = 7.8) and a median of 42. At T1, mean GOHAI was 40.7 (sd = 8.2), at T2 mean GOHAI was 41.1 (sd = 7.8) and at T3, GOHAI was 42.3 (sd = 8.2). GLMM showed that GOHAI improved significantly from T0 to T3 (p = 0.01) but the time by intervention interaction was not significant indicating that both interventions were effective in improving GOHAI but one intervention was not better than the other. Ethnicity, health status, worries, self-efficacy, number of missing teeth and symptoms of dry mouth were related to improvements in GOHAI. Neither GI nor PS were related to GOHAI.ConclusionsThe participants reported relatively good oral health related quality of life which improved significantly over time. Improvement occurred among all participants regardless of condition, suggesting that either intervention would be effective in future studies.Trial registryClinicaltrials.gov, Clinical Trials ID #NCT02419144; Title: A Bi-level Intervention to Improve Older Adult Oral Health Status; Registered 04/07/2015 URL: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0005H9X&selectaction=Edit&uid=U0000KBK&ts=2&cx=-rajj5q.

Project description:BackgroundAdults at high risk for diabetes may have reduced health-related quality of life (HRQoL).ObjectiveTo assess changes in HRQoL after interventions aimed at diabetes risk reduction.Design, setting, and participantsA randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups.InterventionsIntensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB).MeasurementsHRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %.ResultsAfter a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score.ConclusionOverweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.

Dataset Information

Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial.

Publications

Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial.

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