Trial document




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  DRKS00012998

Trial Description

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Title

Unexpressed and unmet needs, burdens and worries of cancer patients during inpatient rehabilitation

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Trial Acronym

UNSAID

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URL of the Trial

http://www.psychotherapie.uni-wuerzburg.de/forschung/unsaid.html

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Brief Summary in Lay Language

Psychosocial interventions can reduce emotional distress in cancer patient. However, patients’ psychosocial needs are often overlooked by physicians. Potential needs and burdens are usually addressed during the initial interview at admission to an oncological rehabilitation. Nevertheless, many cancer patients do not express their emotional distress and need for psychosocial support. This may hinder their allocation to psychosocial interventions. The aim of this study is to investigate which psychosocial needs and burdens cancer patients withhold or are overlooked during rehabilitation. Furthermore we want to find out why they are withheld or overlooked. Therefore, we conduct interviews with cancer patients during rehabilitation and members of cancer support groups as well as health-care professionals. Based on the results of these interviews, 400 cancer patients will be investigated at the end of their rehabilitation as well as after three and nine months, using self-reported questionnaires.

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Brief Summary in Scientific Language

Cancer patients with emotional distress should be offered psycho-oncological interventions to increase their quality of life and reduce symptoms of depression or anxiety. However, patients’ needs for psychosocial support are often overlooked by physicians. Potential needs and burdens are usually addressed during the admission interview of an inpatient oncological rehabilitation intervention. Nevertheless, many cancer patients do not express their emotional distress and needs. This may preclude allocating them to psychosocial interventions, such that undertreatment may occur. Up to now, there are no systematic surveys on this subject in the German-speaking area.
The aim of this study is to investigate firstly which psychosocial needs and burdens cancer patients withhold or are overlooked during inpatient rehabilitation and secondly what the reasons are why they are withheld or overlooked.
Methods: In the first part of the study, we conduct qualitative interviews with oncological rehabilitants, members of cancer support groups, and health-care professionals. We will use content analysis to interpret the data. In the second part of the study, we conduct a quantitative survey with three times of measurement. 400 oncological rehabilitants (breast, prostate, and colorectal cancer) will be investigated at the end of their rehabilitation as well as at 3- and 9-months follow-up with self-reported questionnaires.

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Organizational Data

  •   DRKS00012998
  •   2017/09/15
  •   [---]*
  •   yes
  •   Approved
  •   71/17, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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

  •   C50 -  Malignant neoplasm of breast
  •   C61 -  Malignant neoplasm of prostate
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   C21 -  Malignant neoplasm of anus and anal canal
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Interventions/Observational Groups

  •   Unexpressed needs, burdens and worries of cancer patients as well as explanatory variables will be assessed using self-report questionnaires. Data will be assessed at discharge of inpatient rehabilitation as well as and after 3 and 9 months.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Unexpressed needs, burdens and worries as well as reasons why they are withheld (self-developed questionnaire); time frame: end of rehabilitation, 3- and 9-months follow-up

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Secondary Outcome

Explanatory variables:
- Subjektiv rated shortage of medical and psychosocial treatment, satisfaction wit rehabiliation treatment, satisfaction with previous medical treatment, rating of initial medical interview and examination (self-developed questionnaire); time frame: end of rehabilitation, 3- and 9-months follow-up
- Depression and anxiety (PHQ-2, GAD-2)
- Psychosocial distress (self-development, OEXIOM)
- Fear of progression (PA-F-KF)
- Health-related quality of life (EORTC QLQ-C30); time frame: end of rehabilitation, 3- and 9-months follow-up
- Soziodemographic data; time frame: end of rehabilitation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/08/13
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

cancer patients (breast, prostate, and colorectal cancer) at the end of inpatient rehabilitation;
informed consent

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Exclusion Criteria

Inadequate German language ability, and severe visual impairment (not corrected).

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Addresses

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    • Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Mr.  Prof. Dr. Dr.  Hermann  Faller 
    • Klinikstr. 3
    • 97070  Würzburg
    • Germany
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    • Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Mr.  Dr.  Michael  Schuler 
    • Klinikstr. 3
    • 97070  Würzburg
    • Germany
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    • Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Ms.  M.Sc. Psych.  Verena  Heß 
    • Klinikstr. 3
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Deutsche Krebshilfe
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.