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NCT07466212
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Conditions: Cancer, Type 2 Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 920
Sponsor: Odense University Hospital
Location: Onkologisk afdeling, Klinik Kirurgi og Kræftbehandling Aalborg
Summary
The goal of this observational study is to see how type 2 diabetes affects quality of life in cancer patients receiving immunotherapy. We want to know if patients with diabetes have a greater decline in quality of life over six months compared to those without. The main question we aim to answer is:
\- How does quality of life change over six months in patients with versus without diabetes?
Participants will complete quality-of-life surveys at the start, then at 3 and 6 months. This will help us see if diabetes adds extra challenges during cancer treatment
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* Histologically confirmed solid malignant tumor.
* Planned treatment with ICI monotherapy or dual-ICI combination therapy (metastatic, adjuvant, or neo-adjuvant settings).
* Previous systemic anticancer therapy other than ICI is allowed.
* Ability and willingness to provide written informed consent and to complete HRQoL questionnaires.
* Sufficient Danish language proficiency to read, and complete study questionnaires.
Exclusion Criteria:
* Previous ICI treatment within 6 months.
* Concurrent systemic anticancer therapy other than ICI.
* Declines or does not provide informed consent.
* Cognitive or physical impairment preventing valid consent or completion of patient-reported outcomes.
Source: ClinicalTrials.gov (NCT07466212). StuddyBuddy aggregates publicly available trial information.