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临床试验/NCT07195448
NCT07195448招募中不适用

The GRACE Study - Global Research on Appearance in Cancer

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年2月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Goodrose-Flores

RDN, PhD

Karolinska Institutet

研究点 (1)

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