Acceptability and Preliminary Effectiveness of a Mobile Health Intervention (Untire App) for Adult Cancer Patients and Survivors With Cancer Related Fatigue: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- The change in mean level of acceptability (as measured by the Acceptability E-scale)
研究概览
简要总结
The aim of this study will be to assess the engagement and acceptability of the Untire mHealth intervention for adults with cancer related fatigue. Acceptability will be assessed after 2, 4, 6 and 12 weeks of app use. Participants (both those competed the study and those who stopped using the app) will be asked about their engagement with the app.
A secondary aim of this study will be to provide preliminary efficacy outcomes of the Untire intervention in reducing fatigue and QoL in adults experiencing cancer related fatigue.
详细描述
Cancer-related fatigue (CRF) is one of the most severe and commonly reported side effects of cancer treatment. There is a growing body of evidence that mHealth interventions (digitally delivered using a smart phone app) are effective at reducing CRF. The Untire app is a mHealth app is a registered medical device (ICD10 code R53.83 Fatigue) introduced in 2018 to treat CRF. One limitation common to most digitally delivered interventions is high levels of study drop out and decreased app use over time.
The aim of this study will be to assess the engagement and acceptability of the Untire mHealth intervention for adults with cancer related fatigue.A secondary aim of this study will be to provide preliminary efficacy outcomes of the Untire intervention in reducing fatigue and QoL in adults experiencing cancer related fatigue. The hypotheses for these efficacy outcomes are:
Hypothesis 1: Participants using the Untire app intervention will show reduced levels fatigue (as measured by scores on the fatigue subscale of the FACT-F) after 12 weeks compared to baseline.
Hypothesis 2: Participants using the Untire app intervention will show improved QoL (as measured by scores on the FACT-F) after 12 weeks compared to baseline.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with cancer or cancer survivors (18 years and older).
- •Self-reported current diagnosis or previous history of treatment for cancer (cancer survivor).
- •A moderate or severe level of fatigue as measured by items 1-3 of the Brief Fatigue Inventory (BFI).
- •Access to a smart phone, tablet, or iPad (Apple or Android).
排除标准
- •Participants < 18 years of age
- •Non-English language speakers
- •Participants with a diagnosis of and receiving treatment for severe psychological distress (e.g. major depression, psychotic disorder, anxiety disorder, or addiction).
- •Participants with a diagnosis of chronic fatigue syndrome, myalgic encephalomyelitis, or fibromyalgia.
- •Previous or current us of the Untire app
结局指标
主要结局
The change in mean level of acceptability (as measured by the Acceptability E-scale)
时间窗: From 2 weeks to final time point at 12 weeks. Participants will complete this scale at four time points (after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use).
Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs in oncology and other health populations. This is a six-item scale measuring how easy and enjoyable the app is to use, how understandable were the questions, how helpful was completing the intervention, whether the amount of time to complete the program was acceptable, and overall satisfaction with the program. This is a valid and reliable measure which has previously been used to evaluate patient perceptions of e-health interventions in an oncology setting. Responses are on a simple 5-point numerical scale; 1 indicates a negative and 5 indicates a positive evaluation. Scores range can range from 6-30 with higher scores indicating a higher level of acceptability. The scale will be adapted with the appropriate wording for this study.
The change in mean level of digital working alliance (as measured by the Digital working Alliance Inventory, D-WAI).
时间窗: From 2 weeks to final time point at 12 weeks. Participants will complete the D-WAI at four timepoints (after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use).
The D-WAI is a brief questionnaire used to assess digital working alliance. The 6-items are based on the successful validation of a short form of the Working Alliance Inventory (WAI-SR) comprising of the same core factors of Goals, tasks, and bond. The D-WAI has adequate internal consistency and test-retest reliability. It is a 6-item self-report questionnaire with responses rated on a seven-point Likert scale, ranging from 1 (strongly disagree) to 7 (Strongly agree).
次要结局
- The change in mean level of fatigue (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F)(From baseline to final time point at 12 weeks. Participants will complete the FACT-F at five time points (at baseline and after 2 and then again after 2 weeks (T2), 4 weeks (T4), 6 weeks (T6) and after completion of the intervention at week 12 (T12).)
- The change in mean level of quality of life (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, FACT-F)(From baseline to final time point at 12 weeks. Participants will complete the FACT-F at baseline, and then after 2 weeks, 4 weeks, 6 weeks and 12 weeks of app use.)
研究者
Emil Vuillermoz
Principle Investigator
University of Bath