Clinical trial NCT01021371: The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
Official title: The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: HRQOL (Health Related Quality Of Life)
Keywords: HRQOL
Rehabilitation
Cancer Patients
General Practice
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Vejle Kommune
First posted: 2009-11-30
Enrollment: 959
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility 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

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: 14 months
Secondary outcomes:
measure: How the GP act with regard to rehabilitation among cancer patients
timeFrame: 14 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Reserch Unit of General Practice, Institute of Public Health, University of Southern Denmark
Study officials:
References:
citation: Bergholdt SH, Hansen DG, Larsen PV, Kragstrup J, Sondergaard J. A randomised controlled trial to improve the role of the general practitioner in cancer rehabilitation: effect on patients' satisfaction with their general practitioners. BMJ Open. 2013 Jul 3;3(7):e002726. doi: 10.1136/bmjopen-2013-002726. Print 2013.
citation: Bergholdt SH, Larsen PV, Kragstrup J, Sondergaard J, Hansen DG. Enhanced involvement of general practitioners in cancer rehabilitation: a randomised controlled trial. BMJ Open. 2012 Apr 16;2(2):e000764. doi: 10.1136/bmjopen-2011-000764. Print 2012.