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Involvement of Patients and Relatives in the Course of Cancer Disease (KRIPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01060761
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):

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
Rehabilitation Cancer Relatives Behavioral: Rehabilitation program

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  (Clinical Trial)
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 : March 2010
Primary Completion Date : November 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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 Name: 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, [ Time Frame: two months and one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060761

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Principal Investigator: Helle P Hansen, Professor University of Southern Denmark
More Information

Responsible Party: Helle Ploug Hansen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01060761     History of Changes
Other Study ID Numbers: HMS-SDU- 2009-1
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: June 2012

Keywords provided by Helle Ploug Hansen, University of Southern Denmark:
Rehabilitation program (patient and a relative together)
retreat weekend