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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060761
First Posted: February 2, 2010
Last Update Posted: November 6, 2017
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.
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Helle Ploug Hansen, University of Southern Denmark
  Purpose

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 Intervention
Rehabilitation Cancer Relatives Behavioral: Rehabilitation program

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Helle Ploug Hansen, University of Southern Denmark:

Primary Outcome Measures:
  • Quality of life, [ Time Frame: two months and one year ]

Enrollment: 42
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Locations
Denmark
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
  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 Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: November 6, 2017
Last Verified: June 2012

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