Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.

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: NCT01021371
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Vejle Hospital
Vejle Kommune
Information provided by (Responsible Party):
Stinne Holm Bergholdt, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE November 27, 2009
First Posted Date  ICMJE November 30, 2009
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2009)
Health Related Quality of Life [ Time Frame: 14 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2009)
How the GP act with regard to rehabilitation among cancer patients [ Time Frame: 14 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
Official Title  ICMJE The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
Brief Summary The aim of this study is to investigate the impact of a joint effort towards intensifying the collaboration and communication between hospital and general practice.
Detailed Description

Background

In recent years an increasing focus has been on the unfulfilled needs of cancer patients for an individual rehabilitation taking into consideration the physical, psychological, social, economic, as well as work-related consequences of the cancer disease. Furthermore, there is a great need for ongoing adjustments of the organisation and procurement of rehabilitation offers and for optimizing the continuity of care, especially regarding transfer between sectors.

Research question

The aim of this study is to investigate whether a joint effort towards intensifying the collaboration and communication between hospital and general practice and encouraging the GP to take an active and prominent part in the rehabilitation process on actual patients has any effect on:

  1. Health Related Quality of Life
  2. The rehabilitation of cancer patients
  3. The experience of continuity of care among cancer patients
  4. How the GP act with regard to rehabilitation among cancer patients

Material and methods

The study uses a randomised, controlled design and is carried out as a PhD project. At Vejle Hospital approximately 1000 patients (500 in the intervention group and 500 in the control group) was included at the initiation of treatment. The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The data will be obtained from public health registers and questionnaires to patients 6 and 14 months after the time of diagnosis (measuring Health Related Quality of Life, satisfaction with and use of rehabilitation activities, perceived continuity of care and satisfaction with their GP) and to GPs after 12 months (measuring satisfaction with the information from the hospital and activities to meet the patients' rehabilitation needs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE HRQOL (Health Related Quality Of Life)
Intervention  ICMJE Behavioral: Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs
The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The control group is assigned to usual procedures.
Study Arms  ICMJE
  • Experimental: Patient interview and communication to GP from hospital
    Intervention group: The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group about their rehabilitation needs and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus.
    Intervention: Behavioral: Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs
  • No Intervention: Control group: Usual practice, no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2009)
959
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All new cancer patients receiving treatment, be it surgery, chemotherapy or radiation, at Vejle Hospital in the period of inclusion.

Exclusion Criteria:

  • Patients diagnosed more than 3 months earlier
  • Patients younger than 18
  • Patients with non-melanoma skin cancer.
  • Patients with recurrence of a previous cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01021371
Other Study ID Numbers  ICMJE RCT Cancer rehab
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stinne Holm Bergholdt, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE
  • Vejle Hospital
  • Vejle Kommune
Investigators  ICMJE Not Provided
PRS Account University of Southern Denmark
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP