A complex intervention to enhance the involvement of general practitioners in cancer rehabilitation. Protocol for a randomised controlled trial and feasibility study of a multimodal intervention

Abstract

Background. The effect of interventions that support rehabilitation among cancer patients has to be tested before implementation. Objective. A randomised controlled trial was conducted to test the hypothesis that a multimodal intervention may give the general practitioner (GP) an enhanced role and improve rehabilitation for cancer patients. The intervention included an interview about rehabilitation needs with a rehabilitation coordinator (RC), information from the hospital to the general practitioner about individual needs for rehabilitation and an incentive for the GP to contact the patient about rehabilitation. The objective of this first report from the study was to examine the acceptability and feasibility of the intervention. Material and methods. Adult patients treated for incident cancer at Vejle Hospital, Denmark were included between May 12, 2008 and February 28, 2009. All general practices in Denmark were randomised. Patients were allocated to intervention or control (usual procedures) based on the randomisation status of their GP. The feasibility of the intervention was analysed with regard to recruitment of patients, acceptability by patients and GPs and the degree to which the planned contacts between patients, RCs and GPs were implemented. The primary outcome of the randomised controlled trial (RCT) will be health-related quality of life at six months (EORTC-30). Results. Following assessment of 1 896 cancer patients, 955 patients (50%) registered with 323 general practices were included. The interview was conducted at the hospital with 50% of the patients in the intervention group, 31% were contacted by phone. Patients valued the fact that the conversation was dedicated to needs beyond the medical treatment. The GPs were generally available for information by phone and positive towards having a central role in the cancer rehabilitation. Discussion. It was feasible to conduct a RCT to evaluate a complex intervention in the healthcare system. All elements of the intervention were acceptable and feasible and may be implemented in future practice if the effect is positive.

Acknowledgements

The authors wish to thank all patients and health care professionals who took part in the study. We also wish to thank Lise Stark, Research Unit of General Practice, University of Southern Denmark, for proofreading the manuscript. This study is 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. The study has been registered at Clinical-Trials.gov with the registration ID number: NCT01021371.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.