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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334096
• Other study ID #: TUZ-QL-Mamma-16
• Secondary ID: 111169
• Status: Completed
• Phase: N/A
• Start date: May 30, 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Tumor Center Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 30, 2020
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• breast cancer
• operated in one of two participating certified centers for breast cancer (Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe, Regensburg; Krankenhaus Barmherzige Brüder, Klinik St. Hedwig, Poliklinik für Frauenheilkunde und Geburtshilfe, Regensburg)
• informed consent

Exclusion Criteria:

• unavailability of recruiting study clinician
• patient misclassified in the operation schedule (no breast neoplasm)
• coordinating practitioner refused trial participation
• no "Nachsorgekalendernummer" available ("Nachsorgekalendernummer": unique number of the diary the patient receives in the hospital for aftercare during breast cancer)
• patient from district outside the defined study region
• age under 18 years
• pregnancy
• patient unable to fill out the QoL questionnaire (physical, psychological, cognitive, language reasons)
• patient refused trial participation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Germany	Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg	Regensburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Tumor Center Regensburg	German Cancer Aid

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstädter F, Lorenz W; Regensburg QoL Study Group. Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer. 2008 Aug 5;99(3):415-22. doi: 10.1038/sj.bjc.6604505. — View Citation

Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstädter F, Lorenz W; Regensburg QoL Study Group. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012 Feb 28;106(5):826-38. doi: 10.1038/bjc.2012.4. Epub 2012 Feb 7. — View Citation

Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstädter F, Lorenz W. Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg. 2008 Jan;393(1):1-12. Epub 2007 Jul 28. — View Citation

Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstädter F, Lorenz W, Steinger B. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:460. doi: 10.1186/s13063-015-0972-y. — View Citation

Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Fürst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a need for QoL therapy	a need for QoL therapy is defined as a score <50 points in at least one of eleven QoL dimensions of the EORTC QLQ-C30 and QLQ-BR23 (scales: global quality of life, physical, role, emotional, cognitive, social functioning, pain, fatigue, financial situation, body image, arm symptoms); scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.	6 months after the date of surgery for breast cancer
Secondary	proportions of patients with a need for QoL therapy in each dimension of the QoL profile	a need for QoL therapy is defined as a score <50 points on each single QoL dimension of the EORTC QLQ-C30 and QLQ-BR23 (scales: global quality of life, physical, role, emotional, cognitive, social functioning, pain, fatigue, financial situation, body image, arm symptoms); scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.	3, 6, 9, 12, 18, and 24 months after the date of surgery for breast cancer
Secondary	patient evaluation	semistructured, self-created questionnaire composed of quantitative and qualitative questions to evaluate clinical relevance of the QoL pathway for patients; for each single question answers are analyzed dichotomously (yes/no) and reported as absolute and relative frequencies	6 and 24 months after the date of surgery for breast cancer
Secondary	physician evaluation	semistructured, self-created questionnaire composed of quantitative and qualitative questions to evaluate clinical relevance of the QoL pathway for physicians; for each single question answers are analyzed dichotomously (yes/no) and reported as absolute and relative frequencies	6 and 24 months after the date of surgery for breast cancer