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Rehabilitation medicine
Research
Enhanced involvement of general practitioners in cancer rehabilitation: a randomised controlled trial
  1. Stinne Holm Bergholdt,
  2. Pia Veldt Larsen,
  3. Jakob Kragstrup,
  4. Jens Søndergaard,
  5. Dorte Gilså Hansen
  1. National Research Centre for Cancer Rehabilitation, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Dr Stinne Holm Bergholdt; sbergholdt{at}health.sdu.dk

Abstract

Objective To test the hypothesis that a multimodal intervention giving the general practitioner (GP) an enhanced role in cancer rehabilitation improves patients' health-related quality of life and psychological distress.

Design Cluster randomised controlled trial. All general practices in Denmark were randomised to an intervention group or to a control group. Patients were subsequently allocated to intervention or control (usual procedures) based on the randomisation status of their GP.

Setting All clinical departments at a public regional hospital treating cancer patients and all general practices in Denmark.

Participants Adult patients treated for incident cancer at Vejle Hospital, Denmark, between 12 May 2008 and 28 February 2009. A total of 955 patients (486 to the intervention group and 469 to the control group) registered with 323 general practices were included.

Intervention The intervention included an interview about rehabilitation needs with a rehabilitation coordinator at the regional hospital, information from the hospital to the GP about individual needs for rehabilitation and an encouragement of the GP to contact the patient to offer his support with rehabilitation.

Main outcome measures The primary outcome was health-related quality of life measured 6 months after inclusion using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcomes included quality of life at 14 months and additional subscales of the EORTC QLQ-C30 at 6 and 14 months and psychological distress at 14 months using the Profile of Mood States Scale.

Results No effect of the intervention was observed on primary and/or secondary outcomes after 6 and 14 months.

Conclusion A multimodal intervention aiming to give the GP an enhanced role in cancer patients' rehabilitation did not improve quality of life or psychological distress.

Trial registration ClinicalTrials.gov, registration ID number NCT01021371.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

https://doi.org/10.1136/bmjopen-2011-000764

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    Supplementary materials

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    Footnotes

    • Data All authors had full access to all the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

    • To cite: Bergholdt SH, Larsen PV, Kragstrup J, et al. Enhanced involvement of general practitioners in cancer rehabilitation: a randomised controlled trial. BMJ Open 2012;2:e000764. doi:10.1136/bmjopen-2011-000764

    • Contributors SHB, JK, JS and DGH contributed to conception and study design. SHB, DGH, JK and JS obtained the funding. SHB, JK, JS and DGH wrote the protocol. SHB and DGH were responsible for recruitment of patients. SHB collected and managed the data. PVL was the study statistician. SHB and PVL performed the statistical analysis. SHB, PVL, JK, JS and DGH contributed to the interpretation of data. SHB drafted the first version of the manuscript. SHB, JK, JS, PVL and DGH critically reviewed, revised and supplemented the manuscript. All authors approved the final version. SHB is the guarantor.

    • Funding This study was funded by the Danish Cancer Society, the Novo Nordisk Foundation and the Region of Southern Denmark. The National Research Center for Cancer Rehabilitation is funded by the Danish Cancer Society.

    • Competing interests None.

    • Ethics approval Ethics approval was provided by the Danish Data Protection Agency. The Regional Committee on Biomedical Research Ethics evaluated the project and concluded that the intervention did not need an approval from the Danish National Committee on Biomedical Research Ethics according to Danish law (Project-ID: S-20082000-7).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data available.