Trial document




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  DRKS00013237

Trial Description

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Title

Evaluation of a guided biopsychosocial online-intervention for cancer patients ondergoing chemotherapy (OPaCT) – a feasibility study.

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Trial Acronym

OPaCT

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URL of the Trial

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Brief Summary in Lay Language

Being informed about a cancer diagnosis often changes the lives of the patients and their families in a dramatical way. In addition to the individual concern about one’s own health, many patients are experiencing emotional distress and financial burden. There are, however, some emotionally distressed patients who reject any personal psychosocial support. Uncertainty and inhibitions, a lack of time, physical limitations or reduced mobility may be potential reasons. The present biopsychological internet intervention should contribute towards bridging this supply gap. The aim of this study is to investigate the acceptability and the feasibility of the OPaCT intervention. Moreover, this study intends to examine whether the participation in the OPaCT program leads to an improved psychological condition and an increased patient competency. In total, the OPaCT program comprises eight lessons focusing on various psychological and social aspects of coping with cancer, especially in an early stage of the illness.

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Brief Summary in Scientific Language

Background:
Up to 60% of cancer patients are suffering from distress, anxiety or depression. But there is a great portion of distressed patients who cannot or do not want to accept any psychosocial support. Uncertainty and inhibitions, a lack of time, physical limitations or reduced mobility may be potential reasons. Web-based psychological interventions are increasingly developed in order to bridge this supply gap. The vast majority of the existing internet interventions for cancer patients is addressed to those patients who have already completed their primary cancer treatment. These programs focus on the transition to survivorship phase of cancer journey. Up to know, specialised psychological internet interventions for patients in an early stage of the disease are rare. Therefore, the aim of this study is to investigate the acceptability and the feasibility of the OPaCT intervention which was particularly developed for patients undergoing chemotherapy.

Method:
This study is an exploratory single-arm study. A mixed methods design is used combining qualitative and quantitative data.
N =100 cancer patients undergoing chemotherapy are included in the study. The participation in the study is not dependent on stage or type of tumour. The participating patients will be questioned at the beginning and after completion of the OPaCT intervention.
Primary outcome criteria are aspects of feasibility and acceptability of the OPaCT intervention (dropout rate, satisfaction of the participants, integrability in daily routine, complications and difficulties etc.). These aspects will be collected using qualitative interviews and questionnaires.
Secondary outcome criteria are reduced distress (measured with PHQ-9 and GAD-7), enhanced patient competency (measured with SCNS-SF-34) and increased self-efficacy (measured with CBI-B-D).

Description of the OPaCT intervention:
OPaCT is a web-based guided self-help program comprising psychoeducative as well as interactive supporting elements. It is designed as an easily accessible, module-based intervention consisting of eight modules or lessons. Each of the eight lesson is dedicated to specific psychosocial issues and questions related to coping with cancer (managing the diagnosis, dealing with burdening emotions, talking to family and friends about cancer and its related problems, sports and physical activity during chemotherapy etc.).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013237
  •   2017/10/27
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  •   yes
  •   Approved
  •   S-320/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1202-8783 
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   After an in-depth initial interview, participating patients will have access to the OPaCT intervention. OPaCT consistes of eight lessons. Participants work on 1-2 lessons per week. After each lesson participants will receive a feedback from specially trained psychologist and physicians. On completion of the OPaCT intervention patients will attend a detailed interview where experiences with the intervention will be collected. Additionally participants will complete a questionnaire during the initial and the final interview.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Feasibility and acceptability, recruitment, drop-out rate, participants’ satisfaction, integrability into daily routine are investigated using a semi-standardized questionnaire and qualitative interviews after completion of the intervention.

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Secondary Outcome

Severity of depression (PHQ-9), severity of anxiety (GAD-7), patient competency and subjectiv need for support (SCNS-SF34-D), self-efficacy (CBI-B-D) are investigated at the beginning and after completion of the intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/01
  •   100
  •   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

• tumour disease
• undergoing chemotherapy at the time of the study
• German as native language or excellent German skills
• Internet access

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Exclusion Criteria

• Cognitive or physical limitations impeding the handling of the program (e.g. impaired eyesight)
• Psycholocigal or psychiatric disorders needing treatment

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Addresses

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    • Universitätsklinik Heidelberg Abteilung für Allgemeine Innere Medizin & Psychosomatik
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinik Heidelberg Abteilung für Allgemeine Innere Medizin & Psychosomatik Sektion Psychoonkologie
    • Ms.  Dr.  Miriam  Grapp 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • Psychoonkologische Ambulanz am Nationalen Centrum für Tumorerkrankungen (NCT) in Heidelberg
    • Ms.  Catherine  Schneider 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Nationales Centrum für Tumorerkrankungen (NCT)
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/11/30
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Trial Publications, Results and other Documents

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