Clincosm LogoSign in Get a demo

KRIPP: Involvement of Patients and Relatives in the Course of Cancer Disease

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01060761
Collaborator
Odense University Hospital (Other)
42
Enrollment
1
Location
2
Arms
21
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).

The study evaluate the effect of the program compared to no intervention (usual care)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Rehabilitation program
 N/A

Detailed Description

The study aim to evaluate the effect and the benefit of the program.

First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)

The effect is also assessed in qualitative interviews with patients and their relatives.

The rehabilitation course is investigated in qualitative observations and interviews.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rehabilitation program

Counselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together)

Behavioral: Rehabilitation program
Patient and their relative receive three supportive, structured conversation with a trained nurse. Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities
Other Names:
  • KRIPP project

    		•
    No Intervention: Ususal treatment and support

    Usual support and treatment at the hospital, no retreat Weekend.

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life, [two months and one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Both the patient and their relative must agree to participate together

    • Patient admitted to the Hospital

    • Patient admitted with a lung cancer diagnosis or

    • Patient admitted with a gynecological cancer diagnosis

    Exclusion Criteria:
    • The cancer diagnosis was not verified.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • University of Southern Denmark
    • Odense University Hospital

    Investigators

    • Principal Investigator: Helle P Hansen, Professor, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helle Ploug Hansen, Professor, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT01060761
    Other Study ID Numbers:
    • HMS-SDU- 2009-1
    First Posted:
    Feb 2, 2010
    Last Update Posted:
    Nov 6, 2017
    Last Verified:
    Jun 1, 2012
    Keywords provided by Helle Ploug Hansen, Professor, University of Southern Denmark
    cancer
    Rehabilitation program (patient and a relative together)
    counselling
    retreat weekend

    Study Results

    No Results Posted as of Nov 6, 2017