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

This study has been completed.
Sponsor:
Collaborators:
Vejle Hospital
Vejle Kommune
Information provided by (Responsible Party):
Stinne Holm Bergholdt, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01021371
First received: November 27, 2009
Last updated: October 26, 2016
Last verified: October 2016

November 27, 2009
October 26, 2016
May 2008
February 2009   (final data collection date for primary outcome measure)
Health Related Quality of Life [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021371 on ClinicalTrials.gov Archive Site
How the GP act with regard to rehabilitation among cancer patients [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
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.

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).

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
HRQOL (Health Related Quality Of Life)
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
959
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01021371
RCT Cancer rehab
No
Not Provided
Not Provided
Stinne Holm Bergholdt, University of Southern Denmark
University of Southern Denmark
  • Vejle Hospital
  • Vejle Kommune
Not Provided
University of Southern Denmark
October 2016

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