Quality of Life in cancer patients with diabetes during immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tracks HRQoL in adults with solid tumors treated with immune checkpoint inhibitors. Participants complete surveys at baseline, 3 months, and 6 months to compare those with and without type 2 diabetes. The goal is to see whether diabetes is linked to a greater decline or different trajectory of quality of life during ICI therapy. The study uses patient-reported outcomes to understand the patient experience alongside standard cancer care. No intervention is being tested; methods focus on observation and longitudinal data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kræftafdelingen, Aarhus Universitetshospital
  Aarhus, Denmark Recruiting
• Afdeling for Kræftbehandling, Herlev Hospital
  Herlev, Denmark Recruiting
• Sygehus Lillebælt, Onkologisk afdeling Vejle
  Vejle, Denmark Recruiting
• Onkologisk afdeling, Klinik Kirurgi og Kræftbehandling
  Aalborg, Denmark Not yet recruiting

Study contacts

• Principal investigator: Debbie M Madsen, MD — Onkologisk afd R, OUH
• Study coordinator: Debbie Maria Madsen, MD
• Email: debbie.maria.madsen@rsyd.dk
• Phone: +45 29801558

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.