We conducted a cluster randomised controlled trial, where all general practices in Denmark were randomised to an intervention group or to a control group by means of the unique provider number of each practice. Patients were subsequently allocated according to the randomisation of their GP. Feasibility of the intervention and the study details has previously been published.25
All adult patients (≥18 years) newly diagnosed as having cancer and admitted to Vejle Hospital between 12 May 2008 and 28 February 2009 were assessed for eligibility. Patients were included if treated at Vejle Hospital for a cancer diagnosed within the last 3 months and if listed with a general practice. Patients with carcinoma in situ or non-melanoma skin cancers were not included ().
Study flow. GP, general practitioner.
Two rehabilitation coordinators, both nurses with oncological experience, assessed all patients for eligibility and managed the intervention. The patients were sampled across departments, type of cancer, stage and potential rehabilitation needs by use of the electronic patient files.25
The study was conducted at Vejle Hospital, a public general hospital in the region of Southern Denmark (1.2 million inhabitants).26
Cancer patients were allocated from all departments treating cancer at Vejle Hospital, and could in principle be residents from all parts of Denmark.
The Danish publicly funded healthcare system ensures free access to general practice, which is responsible for primary care needs, and GPs function as gatekeepers to the rest of the healthcare system. More than 98% of all Danish residents are registered with a general practice. On average, each GP meets nine incident cancer patients during 1 year.27
GPs' opportunities to refer patients to relevant rehabilitation services vary between the different municipalities, just as the availability of private patient associations and other relief organisations. These conditions might influence the quality of the rehabilitation interventions offered.
The intervention comprised a patient interview about rehabilitation needs performed by the rehabilitation coordinators, followed by information to the GP about the patient's individual rehabilitation needs and cancer patients' rehabilitation needs in general. The core of the information was that the GP was encouraged to contact the patient to facilitate a rehabilitation process ().
General needs and problems among cancer patients
The patient interviews were conducted according to an interview guide28
and based on a checklist of general needs and problems among cancer patients (). Interviews were most often conducted at the hospital but in some cases, by phone. During the interview, the concept of rehabilitation was explained and the individual needs for physical, psychological, sexual, social, work-related and economy-related rehabilitation were identified. It was explained that physical, psychological, sexual, social, work-related and financial issues1–4
might occur at any time and change during the disease trajectory.7
In order to address these problems, patients were advised to consult their GP during treatment and after discharge. The patients gave oral consent first to their GPs being informed as to their individual problems and needs and second to their GPs being encouraged to be proactive regarding the patients' rehabilitation.
Following each interview, the patient's GP was informed about the patient's actual problems and needs for rehabilitation and encouraged to be proactive, that is, the GP was encouraged to contact the patient personally to offer support and guidance in order to identify and address actual and future needs for rehabilitation. Subsequently, the GP received an email summarising the information, supplemented by general information about cancer patients' needs and problems (). The information was personally conveyed by phone, if possible, and always sent electronically along with the more general information. Patients and GPs in the control group received the usual care and were not contacted by the rehabilitation coordinators.25
Outcomes and sampling of data
The primary outcome was health-related quality of life measured 6 months after inclusion using the Global Health Status of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).30
The secondary outcomes were psychological distress at 14 months assessed by the six scales of the Profile of Mood States32
(depression/dejection, anger/hostility, tension/anxiety, vigour/activity, fatigue/inertia and confusion/bewilderment) and the Global Health Status at 6 months and functional (physical, emotional, role, cognitive or social functioning) and symptom scales (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea or financial difficulties) of the EORTC QLQ-C30 at 6 and 14 months.
Data were sampled in identical ways irrespective of allocation status by use of patient questionnaires administered to patients alive at 6 and 14 months after inclusion. Non-responders were sent one reminder after 3 weeks.25
The sample size was estimated based on the primary outcome measure. According to the EORTC Tables of Reference Values33
for all cancer patients, all stages, the Global Health Status is normally distributed with a mean of 61.3 and an SD of 24.2. A change of at least 8 units was assumed to be clinically relevant.33
If the lowest acceptable statistical power was 80%, then, based on the two-sample t test with a type 1 error α=0.05, the sample size was calculated to be 144 patients per group. The study was subject to clustering because the unit of randomisation was at the level of the GP, whereas the primary outcome measure was at the level of the patient. A strong effect on outcome of the individual practice was expected, but no data supported estimation of cluster effect. To allow maximum clustering, it was attempted to include patients to each group from a minimum of 144 practices.
Prior to study start, all 2181 general practices in Denmark were randomly allocated to the intervention (n=1091) or control (n=1090) group by the unique provider number of each practice using a computerised random-number generator in the statistical program Stata V.10.0 (StataCorp). Hence, randomisation was performed at practice level meaning that all GPs working under the same provider number were allocated to the same group. Consequently, spillover effect between GPs and patients from the same practice was minimised.
The study was not blinded. The list of randomisation was available to the RCs during assessment of patient eligibility. Allocation status was obvious during intervention.
Baseline patient characteristics were described using descriptive statistics in order to present the distribution of age, sex and cancer type. We conducted intention to treat analyses, and numerical outcomes of the randomised controlled trial were analysed using a multilevel linear model, accounting for possible cluster effects caused by the cluster randomisation. All secondary outcomes were adjusted for confounding effect of age and sex. Missing values were regarded as missing at random. We conducted complete case analyses.
The statistical analyses were performed using Stata V.11.0 (StataCorp.).
Development and piloting of questionnaires and intervention
Before designing the intervention, we reviewed papers, reports and textbooks about the problems faced by cancer patients and GPs with respect to individual rehabilitation and continuity across healthcare sectors.1–3
The questionnaires and the procedures of identification, assessment and inclusion of patients were pilot tested prior to study start. The procedures have been described in detail.25