Abstract

Background

Neurofibromatosis (NF) is a rare genetic disorder associated with substantial deficits in quality of life (QoL). We have previously shown that in this population the Relaxation Response Resiliency Program for NF (3RP-NF) delivered via live videoconferencing is associated with sustained improvement in QoL from baseline through 6-month follow-up over and above an attention placebo control..

Purpose

To examine between- and within-group changes in QoL domains from baseline to 1-year follow-up and 6-month to 1-year follow-up.

Methods

We enrolled and randomized 63 adults with NF. Of these, 52 completed the 6-month follow-up and 53 completed 1-year follow-up. We assessed QoL with the World Health Organization Quality of Life—Brief.

Results

Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes). Participants in the 3RP-NF improved from baseline to 1 year in psychological (8.16; 95% CI: 1.17 to 15.14; p =.023) and social relations QoL (9.93; 95% CI: 1.10 to 18.77; p = .028; within-group changes). There were no other significant differences between or within groups from baseline/6 months to 1 year.

Conclusions

The live video 3RP-NF shows promise in improving QoL dimensions over the course of 1 year. Results should be replicated in a fully powered randomized controlled trial.

Clinical Trial information

ClinicalTrials.gov NCT03406208.

中文翻译：

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通过视频会议对神经纤维瘤病患者进行心身疗法：一年随访分析

摘要

背景

神经纤维瘤病（NF）是一种罕见的遗传病，与生活质量（QoL）严重不足有关。我们先前已经表明，在该人群中，通过实时视频会议交付的NF松弛反应弹性程序（3RP-NF）与从基线到6个月随访期间QoL持续改善有关，而注意安慰剂对照除外。

目的

研究从基线到1年随访以及从6个月到1年随访的QoL域的组间和组内变化。

方法

我们招募了63名患有NF的成年人并对其进行了随机分组。其中52例完成了6个月的随访，53例完成了1年的随访。我们用世界卫生组织的生活质量简评对生活质量进行了评估。

结果

3RP-NF的参与与从基线到1年的身体健康QoL（12.68; 95％置信区间[CI]：1.76至23.59; p = .024）和社会关系QoL（16.81; 95％CI）的持续改善相关。 ：3.03至30.59；p = .018），而不是心理和环境QoL（超出对照组（组间变化））。3RP-NF的参与者在心理（8.16; 95％CI：1.17至15.14; p = .023）和社会关系QoL（9.93; 95％CI：1.10至18.77; p = 0.028;从基线到1年期间有所改善）。组内更改）。从基线/ 6个月到1年，各组之间或组内没有其他显着差异。

结论

实时视频3RP-NF有望在1年的时间内改善QoL尺寸。结果应在完全有力的随机对照试验中复制。

临床试验信息

ClinicalTrials.gov NCT03406208。