NCT01021371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
959

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2008

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

November 27, 2009

Last Update Submit

October 26, 2016

Conditions

HRQOL (Health Related Quality Of Life)

Keywords

HRQOLRehabilitationCancer PatientsGeneral Practice

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life

    14 months

Secondary Outcomes (1)

  • How the GP act with regard to rehabilitation among cancer patients

    14 months

Study Arms (2)

Patient interview and communication to GP from hospital

EXPERIMENTAL

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

Control group: Usual practice, no intervention

NO INTERVENTION

Interventions

Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needsBEHAVIORAL

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.

Patient interview and communication to GP from hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients diagnosed more than 3 months earlier
  • Patients younger than 18
  • Patients with non-melanoma skin cancer.
  • Patients with recurrence of a previous cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reserch Unit of General Practice, Institute of Public Health, University of Southern Denmark

Odense, 5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 23824312DERIVED

  • 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.

    PMID: 22508956DERIVED

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

DK(1)