Forms of self help for prostate cancer: a comparative benefit-risk-analysis of classical self help groups and online support groups

Transkript

1 Trial Description Title Forms of self help for prostate cancer: a comparative benefit-risk-analysis of classical self help groups and online support groups Trial Acronym Forms of self help for prostate cancer URL of the trial [---]* Brief Summary in Lay Language As the consultation from patient to patient plays an important role in oncological diseases, the question arises how the chances of new media develop with regard to classical self help. The aim of this study is to compare an online survey of users of the online support group of the Association of Prostate Cancer Self-Help with data from classical self help groups for prostate cancer. The motivation is to orientate the medical consultation according to the possibly changed patient needs. Brief Summary in Scientific Language Especially in localized prostate cancer there are various treatment options with curative intent. Regarding treatment decision making and coping with the disease the internet is an often used addition. In a non-interventional study at different collectives (online support group vs. classical self help) and based on dynamically designed questionnaires a benefit and risk analysis shall be carried out. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: EK , Ethikkommission der Medizinischen Fakultät der Technischen Universität Page 1 of 7

2 Secondary IDs Universal Trial Number (UTN): U Health condition or Problem studied ICD10: C61 - Malignant neoplasm of prostate Interventions/Observational Groups Arm 1: Online-survey of participants in the prostate cancer online support group Arm 2: Survey (online or paper-based) of participants in classical prostate cancer self help groups Characteristics Study Type: Non-interventional Study Type Non-Interventional: Observational study Allocation: Non-randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Other Purpose: Health care system Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Quality of life of persons affected from prostate cancer measured by the EORTC C30 in the subscale "global health state" Secondary Outcome subjective view of participants (qualitative and quantitative); rating of provided help (4-point Likert scale); stage of disease of more or less active participants (local vs. systemic); pattern of use comparing urban and rural areas (< vs. > 10,000 inhabitants) Page 2 of 7

3 Countries of recruitment DE Locations of Recruitment University Medical Center, University Medical Center Klinik für Allgemeine Innere Medizin und Psychosomatik, Heidelberg Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/07/01 Target Sample Size: 1179 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 14 Years Maximum Age: no maximum age Additional Inclusion Criteria all participants of the online support group or classical self help groups for prostate cancer who are able to provide informed consent Exclusion criteria not able to give informed consent; less than 14 years of age; missing consent Addresses Primary Sponsor Page 3 of 7

4 Primary Sponsor Contact for Scientific Queries Universitätsklinkum "Carl Gustav Carus" an der Technischen Universität f4e c a e d4b314c2f a d444e65 at Contact for Public Queries Page 4 of 7

5 Contact for Public Queries Collaborator, Other Address Klinik für Allgemeine Innere Medizin und Psychosomatik Im Neuenheimer Feld Heidelberg a d a654e716a e386c48796e a33774d42417a at Sources of Monetary or Material Support Private sponsorship (foundations, study societies, etc.) Stiftung "Natur und Umwelt" der Landesbank Baden-Württemberg Am Hauptbahnhof 2 (OE 1301/1 H) Stuttgart Telephone: [---]* [---]* Institutional budget, no external funding (budget of sponsor/pi) Page 5 of 7

6 Institutional budget, no external funding (budget of sponsor/pi) Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2014/06/19 Trial Publications, Results and other documents Abstract A Ihrig, A Brechtel, T Muck, P Maatz, J Huber (2014) Personal interaction or anonymity: comparing online and face-to-face support groups for prostate cancer. Psycho-Oncology 23 (Suppl 3): 107 Abstract T Muck, P Maatz, A Ihrig, J Huber (2014) Selbsthilfe beim Prostatakarzinom: Unterscheiden sich die Nutzer von Online-Angeboten und klassischen Selbsthilfegruppen? Urologe 53 (Suppl 1): 43 Abstract P Maatz, T Muck, A Ihrig, J Huber (2014) Online-Selbsthilfeforen verändern bei 30% der Nutzer die Therapieentscheidung beim Prostatakarzinom hin zu mehr Radiatio und aktiver Überwachung. Urologe 53 (Suppl 1): 67 Additional Trial Attributes Urological disease: prostate cancer If other, please specify: any stage Onset of therapy: other If other, please specify: any type of therapy If other, please specify: [---]* Study recommendations: other If other, please specify: health services research German director of clinical investigation: Page 6 of 7

7 German director of clinical investigation: Mr. Dr. med. Dr. phil. Johannes Huber Telephone: +49 (0) johannes.huber at uniklinikum-dresden.de Further contact: Klinik für Allgemeine Innere Medizin und Psychosomatik Mr. Dr. sc. hum. Andreas Ihrig Im Neuenheimer Feld Heidelberg Telephone: andreas.ihrig at med.uni-heidelberg.de Function of contact: cooperating scientist Non-interventional study: Yes Stage: Other * This entry means the parameter is not applicable or has not been set. *** This entry means that data is not displayed due to insufficient data privacy clearing. Page 7 of 7