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

NCT04334096 | Completed DMC

• 2 other identifiers: TUZ-QL-Mamma-16111169
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Breast Cancer; Breast Neoplasms

Keywords

quality of life; breast cancer; complex intervention; long-term implementation; health services research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• proportions of patients with a need for QoL therapy in each dimension of the QoL profile

  3, 6, 9, 12, 18, and 24 months after the date of surgery for breast cancer

• patient evaluation

  6 and 24 months after the date of surgery for breast cancer

• physician evaluation

  6 and 24 months after the date of surgery for breast cancer

Study Arms (1)

QoL diagnosis and therapy

EXPERIMENTAL

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.

Behavioral: quality of life pathway

Interventions

quality of life pathway BEHAVIORAL

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.

Also known as: quality of life diagnosis and therapy; quality of life pathway

QoL diagnosis and therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tumor Center Regensburg: lead
• German Cancer Aid: collaborator

Study Sites (1)

Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (6)

• 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.

  PMID: 32179445 BACKGROUND

• 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.

  PMID: 26467994 BACKGROUND

• 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.

  PMID: 22315052 BACKGROUND

• 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.

  PMID: 18665187 BACKGROUND

• 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.

  PMID: 17661076 BACKGROUND

• 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.

  PMID: 34176020 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monika Klinkhammer-Schalke, MD, Prof.

  Tumor Center Regensburg

  STUDY CHAIR

• Patricia Lindberg-Scharf, PhD

  Tumor Center Regensburg

  PRINCIPAL INVESTIGATOR

• Brunhilde Steinger, MD

  Tumor Center Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Tumor Center Regensburg

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 6, 2020
• Study Start: May 30, 2016
• Primary Completion: January 18, 2019
• Study Completion: September 30, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after date of publication until 60 months after date of publication
• Access Criteria: Data will be made available to other scientists upon request for nonprofit research. The contact address is monika.klinkhammer-schalke@ukr.de. Scientists are required to send their predefined statistical analysis plan. Together with the scientific review board of the Tumor Center Regensburg a decision will be made based on the quality and usefulness of planned statistical analysis. In case of a positive decision the scientist is required to sign a contract for data usage before receiving anonymized IPD.

Locations

DE (1)