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一项专为患有癌症相关疲劳的农村癌症幸存者设计的新型远程医疗锻炼计划:单臂可行性试验。

A Novel Telehealth Exercise Program Designed for Rural Survivors of Cancer With Cancer-Related Fatigue: Single-Arm Feasibility Trial.

作者信息

Marker Ryan J, Kittelson Andrew J, Scorsone Jared J, Moran Ian A, Quindry John C, Leach Heather J

机构信息

Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.

School of Physical Therapy and Rehabilitation Science, University of Montana, Missoula, MT, United States.

出版信息

JMIR Cancer. 2025 Jan 10;11:e59478. doi: 10.2196/59478.

Abstract

BACKGROUND

Exercise interventions are among the best-known interventions for cancer-related fatigue (CRF). Rural survivors of cancer, however, report specific barriers to engaging in exercise programs and lack overall access to effective programs.

OBJECTIVE

The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with CRF.

METHODS

A single-arm clinical trial of the BfitBwell Telehealth Program was performed. Based on an established clinical program, this adapted 12-week program addressed barriers previously reported by rural survivors by providing synchronous videoconference exercise sessions (2 per program), asynchronous exercise sessions using a personal training smartphone or internet app (3-5 per week), and regular symptom (CRF) monitoring using automated emailed surveys (every 2 weeks). Personalized exercise prescriptions containing aerobic and resistance activities were implemented by cancer exercise specialists. Symptom-triggered synchronous sessions were initiated for participants failing to improve in CRF, as identified by a reference chart of CRF improvements observed during a supervised exercise program. Eligible participants were adult survivors of any cancer diagnosis who had completed treatment with curative intent in the past 12 months or had no planned changes in treatment for the duration of the study, lived in a rural area, and were currently experiencing CRF. Feasibility was assessed by objective measures of recruitment, data collection, intervention acceptability and suitability, and preliminary evaluations of participant responses. CRF was the primary clinical outcome (assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale [FACIT-Fatigue]) and was measured before, after, and 6 months after program completion.

RESULTS

In total, 19 participants enrolled in the study, 16 initiated the exercise program, and 15 completed the program. A total of 14 participants were recruited through internet advertisements, and the total recruitment rate peaked at 5 participants per month. Participants completed 100% of initial and final assessments (30 assessments across all participants) and 93% (70/75 possible surveys across all participants) of emailed surveys and attended 97% (29/30 possible sessions across all participants) of synchronous exercise sessions. In total, 6 participants initiated symptom-triggered sessions, with 6 of 7 initiated sessions attended. The mean FACIT-Fatigue scores significantly improved (P=.001) by 11.2 (SD 6.8) points following the completion of the program. A total of 13 participants demonstrated at least a minimal clinically important difference in FACIT-Fatigue scores (≥ +3 points) at this time. FACIT-Fatigue scores did not significantly change from program completion to 6-month follow-up (n=13; mean change -1.1, SD 3.4 points; P=.29).

CONCLUSIONS

Results from this investigation support the feasibility of the BfitBwell Telehealth Program and a subsequent efficacy trial. Novel program components also provide potential models for improving exercise program efficacy and efficiency through asynchronous exercise prescription and symptom monitoring.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04533165; https://clinicaltrials.gov/study/NCT04533165.

摘要

背景

运动干预是治疗癌症相关疲劳(CRF)最著名的干预措施之一。然而,农村癌症幸存者表示,参与运动项目存在特殊障碍,且普遍无法获得有效的运动项目。

目的

本研究旨在评估一项专门为患有CRF的农村癌症幸存者设计的新型远程医疗运动项目的可行性。

方法

对BfitBwell远程医疗项目进行了单臂临床试验。该项目基于既定的临床项目,为期12周,通过提供同步视频会议运动课程(每个项目2次)、使用个人训练智能手机或互联网应用程序的异步运动课程(每周3 - 5次)以及通过自动电子邮件调查定期进行症状(CRF)监测(每2周一次),解决了农村幸存者之前报告的障碍。癌症运动专家制定了包含有氧运动和抗阻运动的个性化运动处方。对于在监督运动项目中观察到CRF未改善的参与者,根据CRF改善参考图表确定后,启动症状触发的同步课程。符合条件的参与者为任何癌症诊断的成年幸存者,他们在过去12个月内已完成根治性治疗,或在研究期间治疗计划无变化,居住在农村地区,且目前患有CRF。通过招募、数据收集、干预可接受性和适用性的客观指标以及参与者反应的初步评估来评估可行性。CRF是主要临床结局(使用慢性病治疗功能评估 - 疲劳量表[FACIT - 疲劳]进行评估),在项目开始前、结束后以及结束后6个月进行测量。

结果

共有19名参与者登记参加研究,16人开始运动项目,15人完成项目。通过互联网广告共招募了14名参与者,每月招募率最高达到5人。参与者完成了100%的初始和最终评估(所有参与者共30次评估)以及93%(所有参与者共75次可能的调查中的70次)的电子邮件调查,并参加了97%(所有参与者共30次可能课程中的29次)的同步运动课程。共有6名参与者启动了症状触发课程,启动的7次课程中有6次被参加。项目完成后,FACIT - 疲劳平均得分显著提高(P = 0.001)11.2(标准差6.8)分。此时,共有13名参与者的FACIT - 疲劳得分至少有最小临床重要差异(≥ +3分)。从项目完成到6个月随访,FACIT - 疲劳得分无显著变化(n = 13;平均变化 -1.1,标准差3.4分;P = 0.29)。

结论

本研究结果支持BfitBwell远程医疗项目的可行性及后续疗效试验。新的项目组成部分还通过异步运动处方和症状监测为提高运动项目的疗效和效率提供了潜在模式。

试验注册

ClinicalTrials.gov NCT04533165;https://clinicaltrials.gov/study/NCT04533165

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dc2/11759908/017669154394/cancer_v11i1e59478_fig1.jpg

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