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

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Helle Ploug Hansen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01060761
First received: February 1, 2010
Last updated: June 19, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Southern Denmark:

Primary Outcome Measures:
  • Quality of life, [ Time Frame: two months and one year ] [ Designated as safety issue: No ]

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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 1, 2010
Last Updated: June 19, 2012
Health Authority: Denmark: The Ministry of the Interior and Health
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on April 15, 2014