- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07591376
A Reminder App to Improve Physical Activity During Radiotherapy for Lung Cancer - a Pre-study in Healthy Volunteers (APART-LUNG)
Physical activity prior to and during chemo- and/or immunotherapy for lung cancer appears important. This may also be true for patients with lung cancer treated with radiation therapy. However, adherence to an exercise program sometimes may be challenging for the patients, particularly if they experience fatigue or other adverse events.
The question arose whether an easy-to-use mobile app installed on the patient's smart phone reminding patients several times daily to perform a certain number of steps will have a positive effect on their physical activity during a course of radiation therapy. Such an app has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app.
The healthy volunteers have to download a reminder app, which has been designed by the Lübeck based company Nextlabel Offene Handelsgesellschaft (OHG). After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the reminder app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates.
연구 개요
상세 설명
Lung cancer belongs to the most common types of solid cancer in Europe and Northern America. A considerable number of patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) receive conventionally fractionated radiation therapy with or without systemic treatment. Radiation therapy may be associated with adverse events affecting healthy tissues within the radiation field but also with fatigue and a decreased level of physical activity or function. Patients who experience significant treatment-related toxicity may not be able to receive the complete radiation therapy as planned. Maintaining or even improving the level of activity by physical exercise or walking a certain number of steps per day may be helpful in this context. In a retrospective study of 184 cancer patients (including 31 patients with lung cancer), adherence to an exercise program was associated with fewer dose reductions and delays of chemotherapy. Moreover, several studies performed in patients with lung cancer suggested that physical activity had a positive effect on the patient's quality of live. Thus, physical activity prior to and during chemo- and/or immunotherapy for lung cancer appears important. This may also be true for patients with lung cancer treated with radiation therapy. However, adherence to an exercise program sometimes may be challenging for the patients, particularly if they experience fatigue or other adverse events. The question arose whether an easy-to-use mobile app installed on the patient's smart phone reminding patients several times daily to perform a certain number of steps will have a positive effect on their physical activity during a course of radiation therapy. Such an app has been developed within the Interreg project HeAT (Health Advancing Technologies for Elderly). However, before this app can be tested in a prospective trial involving patients, its usability should to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate ten aspects related to the usability of the app. This study will be followed by a clinical trial in lung cancer patients.
The primary objective of this study is to evaluate the usability of a reminder app designed to improve physical activity during radiation therapy for lung cancer. This is a prospective multi-center study (one arm), which is performed in 30 healthy volunteers. The healthy volunteers have to download a reminder app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was <60%, the reminder app was rated as not being useful. If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Possession of and ability to use a smart phone plus a step counter
- Age ≥18 years
- Written informed consent
- Capacity of the participant to consent
Exclusion Criteria:
1. Expected non-compliance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Healthy volunteers evaluating a reminder app
Participants are asked to test the app and complete a questionnaire.
They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app.
|
The participants evaluate a mobile app installed on their smart phone reminding them several times daily to perform a certain number of steps.
the participants are asked to complete a questionnaire and to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Satisfaction with the reminder app
기간: Day 1
|
The participants are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the reminder app.
The satisfaction rate represents the rate of participants who affirmed a statement.
If this rate was <60%, the reminder app was rated as not being useful.
If the rate was between ≥60% but <80%, the app was regarded useful but required further optimization regarding the corresponding section.
|
Day 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dirk Rades, Prof. Dr. med., FASTRO, University of Luebeck, Germany
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- APPAREL-HV
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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