Not Yet RecruitingNot Applicable

QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy

Denmark920 participantsStarted 2026-03-10

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in EORTC QLQ-C30 Global Health Status score

Timeframe: Baseline, 3 months and 6 months

Trial details

NCT IDNCT07466212

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-01

Contact for this trial

Debbie Maria Madsen, MD

+45 29801558 debbie.maria.madsen@rsyd.dk