Objective To analyse the effectiveness of hospital-based case management (CM) in terms of patient-reported outcomes.

Design Randomised controlled trial allocating participants 1 : 1 to either a CM intervention or a control group. Allocation status was evident to participants and case managers, but blinded to researchers.

Setting Patients were recruited at a Danish surgical department where the case managers were situated.

Participants Colorectal cancer patients who were to undergo further investigation or treatment. Exclusion criteria were participation in another study, poor Danish language skills or apparent cognitive impairment. 140 participants were randomised to each group. Recruitment period was 11 March 2009 to 29 December 2010.

Interventions Control group patients had usual care. Intervention group patients had usual care supplemented by hospital-based CM started at first visit to the out-patient clinic (before treatment start) and ended 4 weeks after completed cancer treatment. CM was conducted by nurse case managers who undertook care pathway supervision, information dissemination to health professionals and outreaching patient support.

Outcome measures Patient-reported global quality of life measured with the EORTC QLQ-C30 and eight ad hoc, piloted patient evaluation items assessed at eight, 30 and 52 weeks after randomisation.

Results The two groups were comparable as to questionnaire response rates and completed scales/items. There were no statistically significant group differences on any of the health-related quality of life subscales at eight, 30 or 52 weeks. In patient evaluations, all point estimates favoured CM at week 8 and 30; at week 52, 6 of 7 estimates favoured CM.

Conclusions We found no evidence that CM influenced colorectal cancer patients’ health-related quality of life. Patients allocated to CM evaluated their care more positively than patients receiving usual care.

Trial registration Clinicaltrials.gov identifier: NCT00845247.