Clinical trial NCT04334096: Long-term Improvement of Quality of Life in Breast Cancer Patients With Quality of Life Diagnosis and Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Breast Cancer
Breast Neoplasms
Keywords: quality of life
breast cancer
complex intervention
long-term implementation
health services research
Lead sponsor: Tumor Center Regensburg
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2020-04-06
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients with a need for QoL therapy
timeFrame: 6 months after the date of surgery for breast cancer
Secondary outcomes:
measure: proportions of patients with a need for QoL therapy in each dimension of the QoL profile
timeFrame: 3, 6, 9, 12, 18, and 24 months after the date of surgery for breast cancer
measure: patient evaluation
timeFrame: 6 and 24 months after the date of surgery for breast cancer
measure: physician evaluation
timeFrame: 6 and 24 months after the date of surgery for breast cancer
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg
state: Bavaria
Study officials:
affiliation: Tumor Center Regensburg
name: Monika Klinkhammer-Schalke, MD, Prof.
role: STUDY_CHAIR
affiliation: Tumor Center Regensburg
name: Patricia Lindberg-Scharf, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tumor Center Regensburg
name: Brunhilde Steinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst 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.
citation: Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstadter 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.
citation: Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstadter 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.
citation: Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstadter 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.
citation: Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstadter 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. doi: 10.1007/s00423-007-0210-5. Epub 2007 Jul 28.
citation: Lindberg-Scharf P, Steinger B, Koller M, Hofstadter A, Ortmann O, Kurz J, Sasse J, Klinkhammer-Schalke M. Long-term improvement of quality of life in patients with breast cancer: supporting patient-physician communication by an electronic tool for inpatient and outpatient care. Support Care Cancer. 2021 Dec;29(12):7865-7875. doi: 10.1007/s00520-021-06270-1. Epub 2021 Jun 27.