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临床试验/NCT02982746
NCT02982746已完成不适用

Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer

Göteborg University0 个研究点目标入组 96 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
主要终点
Health related quality of life EORTC QLQ-30 EORTC QLQ-35

研究概览

简要总结

At all of the follow-ups, including the worst period (between four and ten weeks), the intervention group reported higher scores than the control group, suggesting in this RCT that adopting the person-centred-care concept was a promising way to improve function and wellbeing in patients with HNC.

详细描述

Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its treatment may affect general domains of health-related quality of life (HRQoL) and provoke a variety of adverse symptoms and side effects, both during and after treatment. The objective of this study was to compare a person-centred care intervention in terms of HRQoL, disease-specific symptoms or problems, with traditional care as a control group for patients with HNC. Methods: The intervention and control groups comprised 54 and 42 patients, respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. The questionnaires' scores were compared between groups by using independent samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous variables. For categorical data, Fisher's exact test was used. Longitudinal data were analysed using repeated measures in covariance pattern models. Results: At baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported higher scores than the control group. The differences were numerically but not always statistically significant. When using repeated measures in covariance pattern models, statistically significant results were found for HNC-specific problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible for this study were patients diagnosed with HNC, older than 18 years and able to read and write Swedish and, in addition, suitable for outpatient treatment with chemo- and/or radiotherapy, either as primary treatment or in a postoperative setting.

排除标准

  • •Patients were excluded if they had a previous or concomitant malignancy or were diagnosed and treated for depression as stated in their medical record.
  • •In order to minimize the risk of bias, none of the patients were to be included if they were taking part in other research studies

研究组 & 干预措施

gPCC-G (Gothenburg Person Centred Care) Group

Experimental

gPCC-G Patients randomized to the intervention group were contacted and scheduled to attend a meeting at the oncology clinic with the nurse specialist in oncology

干预措施: gPCC (Gothenburg Person Centred Care) (Other)

Control group

No Intervention

Control Group Patients randomized to the control group received usual care and return visits were scheduled according to the treatment procedure described under the previous heading and based on the Regional care program for patients with HNC. CG patients were recruited at the same time and in the same way as those in the intervention group

结局指标

主要结局

Health related quality of life EORTC QLQ-30 EORTC QLQ-35

时间窗: 52 weeks

Health related quality of life EORTC QLQ-30 EORTC QLQ-35

时间窗: Baseline

Health related quality of life EORTC QLQ-30 EORTC QLQ-35

时间窗: Four weeks

Health related quality of life EORTC QLQ-30 EORTC QLQ-35

时间窗: 18 weeks

Health related quality of life EORTC QLQ-30 EORTC QLQ-35

时间窗: 10 weeks

次要结局

未报告次要终点

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

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