Improving quality of life for lung cancer patients through monitoring

Improvement of Quality of Life (QoL) Using Preference-Oriented QoLMonitoring and Linkage with Clinical Registry Data: Randomised Clinical Trial in Patients with Lung Cancer

This study is testing if a special quality of life monitoring system can help lung cancer patients feel better during their regular check-ups compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Bayreuth (Academic / other)
• Locations: 8 sites (Bamberg and 7 other locations)
• Trial ID: NCT06252233 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether a preference-oriented quality of life (QoL) monitoring system can enhance the QoL of patients diagnosed with lung cancer during routine follow-up care. It involves a two-arm randomized controlled trial where one group receives tailored QoL monitoring and the other group receives standard care. The QoL assessment will utilize electronic questionnaires designed for both patients and physicians, based on previous successful interventions in breast and colorectal cancer. The study seeks to adapt and implement this system specifically for lung cancer patients across multiple centers in Germany.

Who should consider this trial

Good fit: Ideal candidates include adults with a primary diagnosis of lung cancer who are within two months of their histological diagnosis and are receiving treatment at one of the participating hospitals.

Not a fit: Patients who are misclassified, outside the study region, or unable to complete the QoL questionnaires may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for lung cancer patients by addressing their specific needs and preferences.

How similar studies have performed: Previous studies have shown success in improving QoL for patients with breast and colorectal cancer using similar monitoring approaches, suggesting potential for success in lung cancer as well.

Eligibility criteria

Inclusion Criteria:

1. primary diagnosis of lung cancer (ICD C33/C34, all stages)
2. treatment in one of six recruiting hospitals treating patients with lung cancer (University Hospital Regensburg, Hospital Barmherzige Brüder Regensburg, Hospital Bayreuth, Hospital Coburg, Hospital Kulmbach, Hospital Bamberg);
3. difference between date of histology and date of study entry not exceeding 2 months;
4. informed consent;

Exclusion Criteria:

1. unavailability of a study clinician for patient recruitment;
2. patient misclassified in the candidate list (no primary diagnosis, no lung tumour);
3. coordinating practitioner refuses trial participation;
4. patient outside the defined study region (Germany, Bavaria: Upper Palatinate, Lower Bavaria, Upper Franconia);
5. age under 18 years;
6. pregnancy/ breastfeeding;
7. patient unable to fill out the QoL questionnaire (physical, psychological, cognitive, language reasons);
8. patient refuses trial participation

Where this trial is running

Bamberg and 7 other locations

• Klinikum Bamberg — Bamberg, Germany (Recruiting)
• Hospital Bayreuth — Bayreuth, Germany (Recruiting)
• Klinikum Coburg GmbH — Coburg, Germany (Recruiting)
• Caritas Krankenhaus St. Maria Donaustauf — Donaustauf, Germany (Recruiting)
• Klinikum Kulmbach — Kulmbach, Germany (Recruiting)
• Krankenhaus Barmherzige Brüder — Regensburg, Germany (Recruiting)
• Universitätsklinikum Regensburg — Regensburg, Germany (Recruiting)
• Klinikum St. Elisabeth Straubing — Straubing, Germany (Recruiting)

Study contacts

• Study coordinator: Martin Emmert, PhD, Prof.

Conditions Lung Cancer; Quality of Life; quality of life; lung cancer; definitive randomised controlled trial; patient empowerment; quality of life monitoring; patient and physician preferences