Trial document




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  DRKS00011183

Trial Description

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Title

Effect of coordinated support for tumor patients by repetitive offers: a prospective randomized controlled trial.

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Trial Acronym

ECHTER-001

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URL of the Trial

http:///

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Brief Summary in Lay Language

In a unicentric trial (Juliusspital Hospital, Wuerzburg, Germany) patients with colorectal, gastric and pancreatic cancer will be studied. Investigators will examine if a repetitive (vs. standard) psychosocial and supportive treatment offers contribute to a measurable improvement in distress and quality of life.

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Brief Summary in Scientific Language

In the context of operative and non-operative cancer treatment supportive care offers are made towards the end of hospital stay. Considering the extreme burden in the acute phase of disease these offers are often not perceived sufficienty.
Patients' relatives, too, are often excessively demanded by the situation. Retrospectively the subjective impression remains after months that supportive care was not offered at all. Faller et al. (2016) found in 36-48% of cancer patients an unmet need for Information. In the present study we plan to investigate if repetitive psychosocial and supportive care offers improve the coping with the burden of disease and the quality of life of cancer patients. Summarizing we want to contribute to the self-determined management of a life crisis by the patient („patient empowerment“).

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Organizational Data

  •   DRKS00011183
  •   2016/11/03
  •   [---]*
  •   yes
  •   Approved
  •   140/16, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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

  •   C16.9 -  Malignant neoplasm: Stomach, unspecified
  •   C20 -  Malignant neoplasm of rectum
  •   C18.9 -  Malignant neoplasm: Colon, unspecified
  •   C25.9 -  Malignant neoplasm: Pancreas, unspecified
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Interventions/Observational Groups

  •   Intensive counselling ("Intervention Group")
    Care with regard to psychooncology and other supportive measures is offered repetitively. Randomly assigned study participants are contacted by telephone at study entry and at 3 additional time points (3 1/2 - 6 1/2 and 9 1/2 months after hospital treatment). They are repeatedly offered the following: medical advice, psychooncological counselling, dietetic advice, sport and physical activities, contact with social services, spiritual support, stoma handling (if applicable), contact with patient self help groups. If necessary a visit at the gastroenterology outpatient clinic of the Juliusspital is offered; on this occasion the supportive care offer will be put into practice.
  •   In this Group ("control") basic supportive care is offered as laid down in the 2015 questionnaire of the German Cancer Society for viszeral oncologic centres. Patients are offered access to psychooncologic counselling and other supportive care only at study entry. It is not formally offered again at definite time points as in the "intervention group".
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The patient's psychosocial burden is measured at time point 0 and after 3 1/2, 6 1/2 und 9 1/2 months using the German Version of the Distress Thermometer.

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Secondary Outcome

Secondary end points are measured at time point 0 and after 3 1/2, 6 1/2 und 9 1/2 months. These include Quality of life by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Score, physical fitness by the ECOG performance Status, malnutrition by the Nutrition Risk Score (NRS).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2016/12/01
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

All newly diagnosed patients with gastric, pancreatic and colorectal cancer (independent of stage and therapy) are included.
Inclusion criteria are also: Mental ability to consent formally, Age between 18 and 80 years at study entry, Estimated life expectancy of 15 months or more (in the palliative setting)

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Exclusion Criteria

Exclusion criteria are Lack of mental ability to consent formally, Age younger than 18 or older than 80 years at study entry, Estimated life expectancy of less than 15 months (in the palliative setting)

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Addresses

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    • Juliusspital Würzburg
    • Juliuspromenade 19
    • 97070  Würzburg
    • Germany
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    • Krankenhaus Juliusspital Würzburg
    • Mr.  Prof. Dr.  Wolfgang  Scheppach 
    • Juliuspromenade 19
    • 97070  Würzburg
    • Germany
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    • Juliusspital Würzburg, Medizinische Klinik
    • Mr.  Prof. Dr.  Wolfgang  Scheppach 
    • Juliuspromenade 19
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Juliusspital Würzburg
    • Juliuspromenade 19
    • 97070  Würzburg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.