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Global Research on Appearance in Cancer (GRACE)

The GRACE Study - Global Research on Appearance in Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07195448
Acronym
GRACE
Enrollment
800
Registered
2025-09-26
Start date
2025-02-10
Completion date
2026-12-31
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Expected survival time \< 3 months

Design outcomes

Primary

MeasureTime frameDescription
Body image2025-2027The 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

MeasureTime frameDescription
Body Image, weight loss, percent weight loss and appetite2025-2027Weight 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).

Countries

Sweden

Contacts

Primary ContactCharlotte Goodrose-Flore, RDN, PhD
charlotte.goodrose.flores@ki.se+46706442303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026