NCT04334096

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

Long-term Improvement of Quality of Life in Breast Cancer Patients With Tailored Quality of Life Diagnosis and Therapy: Implementation Into Routine Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Tumor Center Regensburg · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Quality of Life
• Breast Cancer
• Breast Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	quality of life pathway	The first quality of life (QoL) measurement is conducted in the hospital after surgery via a digital questionnaire (EORTC QLQ-C30, QLQ-BR23) on a tablet computer. Further QoL measures are accomplished via paper-pencil in the practice of the patient's physician during aftercare (3, 6, 9, 12, 18, 24 months after surgery). Paper questionnaires are transferred by fax to a local server, automatically processed, digitized and stored in a database, and transferred back to the physician's practice (email or fax depending on preference) in form of a QoL profile. The immediate response enables patient and physician to discuss the QoL profile right away. Specific therapeutic options for the treatment of QoL have been defined: psychotherapy, social counseling, pain therapy, physiotherapy, nutrition counseling, fitness. To provide continuous medical education, quality circles for each therapeutic option have been founded. Physicians receive a list with addresses of all quality circle members.

Timeline

• Start date: 2016-05-30
• Primary completion: 2019-01-18
• Completion: 2020-09-30
• First posted: 2020-04-06
• Last updated: 2020-11-05

Locations

1 site across 1 country: Germany