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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Southern Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Vejle Hospital
Vejle Kommune
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01021371
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • How the GP act with regard to rehabilitation among cancer patients [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 959
Study Start Date: May 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Control group: Usual practice, no intervention 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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021371

Locations
Denmark
Reserch Unit of General Practice, Institute of Public Health, University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Vejle Hospital
Vejle Kommune
  More Information

No publications provided

Responsible Party: Associate Professor, MD, PhD, Dorte Gilså Hansen, Research Unit for General Practice, Institute of Public Health, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01021371     History of Changes
Other Study ID Numbers: RCT Cancer rehab
Study First Received: November 27, 2009
Last Updated: November 27, 2009
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
HRQOL
Rehabilitation
Cancer Patients
General Practice

ClinicalTrials.gov processed this record on October 01, 2014