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NCT Number: NCT07195448

Global Research on Appearance in Cancer (GRACE)

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Sweden

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of cancer
  • Must be able to understand the consent form

Exclusion criteria

  • Expected survival time < 3 months

Treatment and study plan

Primary outcomes

  1. Body image

    Time frame: 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.

Secondary outcomes

  1. Body Image, weight loss, percent weight loss and appetite

    Time frame: 2025-2027

    Weight loss measured in kilograms and percent lost compared to weight prior to cancer diagnosis.

    Appetite measured by using Edmonton Symptom Assessment Scale (ESAS). Appetite is rated between 0 (best possible appetite) to 10 (no appetite).

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Goodrose-Flore, RDN, PhD

CONTACT

[email protected]

+46706442303

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

The GRACE Study - Global Research on Appearance in Cancer

Acronym: GRACE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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