Trial document




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  DRKS00006056

Trial Description

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Title

COmplementary Nursing in Gynaecologic Oncology-study

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Trial Acronym

CONGO

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URL of the Trial

http://www.klinikum.uni-heidelberg.de/Komplementaermedizinische-Pflegemassnahmen-in-der-gynaekologischen-Onkologie.136557.0.html

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Brief Summary in Lay Language

This study will assess the effectiveness of nursing care interventions including complementary and alternative medicine (CAM) therapies and resource-oriented counselling on CAM. In particular, the study will analyse if the complementary nursing intervention will increase health-related quality of life (HRQoL) in patients with breast and gynaecologic cancer undergoing chemotherapy.

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Brief Summary in Scientific Language

Gynaecologic and breast malignancies constitute nearly half of all malignancies in German women. Health related quality of life (HRQoL) is most adversely affected between diagnosis and end of chemotherapy. In this period, many patients orient themselves towards complementary and alternative medicine (CAM). According to previous studies, up to 70% of patients with gynaecologic/breast cancer use CAM, although 50% do not disclose CAM use. Oncology nurses may be in a key position to support patients with expert information and guidance.
This study will assess effectiveness of complex nursing interventions using counselling and CAM to increase HRQoL in patients with gynaecologic/breast cancer undergoing chemotherapy. Primary outcome measure will be HRQoL assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). Secondary endpoints are nausea, fatigue, anxiety, depression, medication use, perceived quality of care and health economic parameters.
Due to strong patient preferences regarding CAM, we plan a partially randomized patient-preference trial with two randomized arms and two observational (preference-based) arms including 590 patients in two recruiting centres. The first analysis step will be the Intention-to-treat (ITT) analysis of the randomized arms. Using a linear mixed model, the continuous primary endpoint between the randomised groups will be compared. The analysis will be additionally adjusted for relevant covariates such as HRQoL at baseline. The null hypothesis will be tested at the two-sided significance level of 0.05. External validity will be assessed comparing randomised with non-randomised patients.

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Organizational Data

  •   DRKS00006056
  •   2014/04/15
  •   [---]*
  •   yes
  •   Approved
  •   S-008/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50-C50 -  Malignant neoplasm of breast
  •   C51-C58 -  Malignant neoplasms of female genital organs
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Interventions/Observational Groups

  •   Randomised arm: participants will be randomly allocated into the intervention group (usual care + complementary and alternative medicine(CAM)) and the control group (usual care). Participants of the intervention group will receive the CAM intervention at each cycle of chemotherapy. The duration of the intervention will depend upon patient preference and the degree of severity of patient indications. Participants of the intervention group will also receive counselling on interventions, which can be applied at home until the next cycle of chemotherapy.
  •   Observational arm: participants will be allocated based upon their preference into the intervention group (usual care + CAM) and the control group (usual care). Likewise, in this study arm, participants of the intervention group will receive the CAM intervention at each cycle of chemotherapy. The duration of the intervention will depend upon patient preference and the degree of severity of patient indications. Participants of the intervention group will also receive counselling on interventions, which can be applied at home until the next cycle of chemotherapy.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Health-related quality of life: measured with the EORTC-QLQ-C30 at time points T1, T2, T3, T4.

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Secondary Outcome

Secondary outcomes: Nausea (MAT), fatigue (FACIT-F), pain (VAS), anxiety/depression (PHQ-9), social support (F-SozU-K14), self-efficacy (SES6G), patient competence (FEPK 2-57), spiritual wellbeing (Sp-REUK-15), patient satisfaction (EORTC-QLQ-PATSAT32) and health economic data (Mannheimer Modul RV) will be analysed at T1 (start of chemotherapy), T2 (midline), T3 (end of Treatment) and T4 (6 months after Treatment).
Quality of life of patients' caregivers (WHOQOL-BREF) will be collected at time-points T1, T3, and T4.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/07/31
  •   590
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All female patients diagnosed with gynaecologic cancer and scheduled for a new treatment of chemotherapy will be invited for the study.

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Exclusion Criteria

< 18 years, gender: male, insufficient knowledge of German

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Addresses

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    • Abteilung Allgemeinmedizin und VersorgungsforschungUniversitätsklinikum Heidelberg
    • Ms.  Prof. Dr.  Stefanie  Joos 
    • Voßstr. 2
    • 69115  Heidelberg
    • Germany
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    • Abteilung Allgemeinmedizin und VersorgungsforschungUniversitätsklinikum Heidelberg
    • Ms.  Prof. Dr.  Stefanie  Joos 
    • Voßstr. 2
    • 69115  Heidelberg
    • Germany
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    • Abteilung Allgemeinmedizin und Versorgungsforschung
    • Ms.  Prof.  Stefanie  Joos 
    • Voßstr. 2
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • 53170  Bonn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.