QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients with solid malignancies initiating immune checkpoint inhibitor therapy in routine clinical practice, with and without pre-existing type 2 diabetes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
920 Participants
are grouped into 2 trial groupsGroup A: Patients with type 2 diabetes
Group B: Patients without diabetes
Trial outcomes
Primary outcomes
1
Change in EORTC QLQ-C30 Global Health Status score
Change in health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status scale. Scores range from 0 to 100, with higher scores indicating better global quality of life. The outcome compares changes from baseline between patients with type 2 diabetes and patients without diabetes receiving immune checkpoint inhibitor (ICI) therapy.
Time frame
Baseline, 3 months and 6 monthsSecondary outcomes
1
Change in EQ-5D-5L Index Value
Health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The index value is derived from the five EQ-5D dimensions using a population value set, where higher values indicate better health status.
Time frame
Baseline to 3 months and 6 months2
Change in EQ-5D-5L Visual Analogue Scale (EQ-VAS) score
Self-rated health measured using the EQ-5D-5L visual analogue scale (EQ-VAS), where participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame
Baseline, 3 months and 6 months3
Incidence of immune-related diabetes mellitus
Incidence of immune-related diabetes mellitus within 12 months of ICI initiation (number and proportion). Record occurrence of diabetic ketoacidosis at immune-related diabetes mellitus onset.
Time frame
Within 12 months after initiation of ICI.4
Hospital Admissions
Number and type of hospital admissions within 6 months of ICI initiation, categorized Immune-related adverse event related, diabetes-related, or other. Derived measures include time to first hospitalization and length of stay.
Time frame
Within 6 months after initiation of ICI therapy.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: