The GRACE Study - Global Research on Appearance in Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Body image
研究概览
简要总结
Gaining insight into how weight loss is perceived by persons with advanced cancer, and identifying potential differences related to gender and country of residence, is essential for developing comprehensive, equitable, gender-sensitive recommendations for medical nutrition therapy, with the aim of improving disease outcome.
详细描述
This is a multi-country cross-sectional study. Fifty men and 50 women, 18 years and above, diagnosed with advanced cancer, with a life expectancy of > 3 months, from eight countries (Australia, Chile, Germany, New Zealand, Sweden, Switzerland, USA, Vietnam) will be invited to participate. Study participants will be recruited at cancer clinics, where they will receive a QR code providing access a digital questionnaire one time. No personal information, such as name, address, or social security number, is collected. Therefore, the digital questionnaire is anonymous. Data will be collected on various variables, including weight (in kilograms or pounds) and weight history (weight before diagnosis), height (in centimeters or inches), previous weight loss attempts, education (completed high school/completed college), marital status, body image (Body Image Scale, nutrition impact symptoms (Edmonton Symptom Assessment Scale) and dietary habits (questions about choice of foods in the past week).
Regarding missing data, Body Image Scale (BIS), missing items will be handled strictly according to the scoring protocol. No imputation will be applied to other variables, which will be analyzed using complete cases.
The proposed sample size is considered appropriate and sufficient to generate valuable insights for the research community in the field of palliative care. While the sample size is not derived from a formal power calculation, the inclusion of 50 men and 50 women from each study site is anticipated to provide robust and meaningful data to address the study objectives effectively.The data will be processed at Karolinska Institutet, Stockholm, Sweden.
The statistical analysis to address the objectives is ANCOVA, which will be applied to assess group differences while controlling for covariates.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Clinical diagnosis of cancer
- •Must be able to understand the consent form
排除标准
- •- Expected survival time < 3 months
结局指标
主要结局
Body image
时间窗: 2025-2027
The primary outcome measure of the GRACE study is to measure body image, by using Body Image Scale (BIS). The scoring model contains of four possible responses computing a maximum summary score of 21. The possible responses range from "not at all" (0 points) to "very much" (3 points). A higher score indicate a more distressed body image.
次要结局
- Body Image, weight loss, percent weight loss and appetite(2025-2027)
研究者
Charlotte Goodrose-Flores
RDN, PhD
Karolinska Institutet
