Long-term Improvement of Quality of Life in Breast Cancer Patients With

Status Completed

Clinical Trial Summary

The purpose of the study is the long-term implementation of a system with quality of life diagnosis and tailored therapeutic options in order to improve quality of life of patients with breast cancer during follow-up.

Clinical Trial Description

The implementation of quality of life (QoL) concepts in routine care is still an open matter. A pathway with QoL diagnosis and therapeutic options for patients with breast cancer and colorectal cancer has been designed, implemented, and evaluated as guided by the Medical Research Council framework for developing and testing complex interventions. It could be demonstrated that patients with breast cancer and colorectal cancer profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment. The next step is the long-term implementation of the QoL pathway into routine care. In a prospective, single-arm study 200 patients with breast cancer are planned to be recruited. QoL is measured (EORTC QLQ-C30, QLQ-BR23) after surgery (baseline) and during aftercare (3, 6, 9, 12, 18, 24 months). Results of QoL measurements are automatically processed via an electronic data processing (EDP)-aided system and are directly presented to the coordinating practitioner (physician who cares for the patient during aftercare) and the patient in a QoL profile that can be discussed during the current medical appointment. The profile consists of eleven dimensions on scales of 0-100. A cutoff score <50 points defines a need for QoL therapy. Specific therapeutic options for the treatment of QoL have been identified: psychotherapy, social counseling, pain therapy, physiotherapy, nutrition counseling, and fitness. To provide continuous medical education, quality circles for each therapy option have been founded. Coordinating practitioners receive a list with addresses of all quality circle members. The primary endpoint of the study is the proportion of patients with a need for QoL therapy 6 months after surgery as well as the evaluation of clinical relevance of the QoL pathway by patients and physicians. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04334096
Study type	Interventional
Source	Tumor Center Regensburg
Contact
Status	Completed
Phase	N/A
Start date	May 30, 2016
Completion date	September 30, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Long-term Improvement of Quality of Life in Breast Cancer Patients With Quality of Life Diagnosis and Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms