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Completed

NCT Number: NCT04334096

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

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.

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Key information

Conditions

Quality of Life Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Regensburg, Bavaria, 93053, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: quality of life diagnosis and therapy; quality of life pathway

Primary outcomes

  1. proportion of patients with a need for QoL therapy

    Time frame: 6 months after the date of surgery for breast cancer

    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.

Secondary outcomes

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

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

    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.

  2. patient evaluation

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

    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

  3. physician evaluation

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

    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

Sponsors and collaborators

Lead sponsor

Tumor Center Regensburg

Other

Collaborators

  • German Cancer Aid

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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