RESTART: Rehabilitation Evaluation in Survivors of Testicular Cancer after Radical Treatment—Pilot study effect on HADS-anxiety subscore.

Abstract

9590 Background: Most testis cancer (TC) patients are cured, but some experience significant physical and psychological consequences. Multi-dimensional rehabilitation programmes have largely been studied in breast cancer, with positive effects on physical and psychological well being. The needs of young males are likely to be significantly different. Addressing the ‘Survivorship agenda’, we performed a study of the feasibility, composition and acceptability of a rehabilitation programme for TC patients. Methods: TC patients, aged >16, who had completed all radical treatment within the preceding 8 weeks, with no major cardio-respiratory problems were eligible. The 6 week multi-dimensional programme consisted of the following; exercise, psychological wellbeing, nutrition, finance, fertility, return to work and follow up. Primary end point was change in the HADS anxiety sub-score from pre (Week 1) to post the programme (Week 6). To detect with 90% power at the 10% 1-sided level of statistical significance a within patient change of 1.5 in the HADS anxiety sub-score (assuming a within patient SD of 3), 26 evaluable participants were required. Secondary objectives were the effect on QOL, HADS depression, exercise capacity and BMI. Results: 35 patients were recruited in 5 cohorts between Feb 2012 and Nov 2012 from 2 UK Cancer Centres; 32 patients were evaluable for the primary end point. Mean age at registration was 38 years (SD =10.45). 94% of the evaluable participants attended 5 or more sessions (30/32 participants). Participant feedback; 36.7% rated their overall score as 10 out of 10, with 93% of participants rating the programme ≥8. Conclusions: A multi-faceted rehabilitation programme appears deliverable and acceptable in TC patients. The study demonstrates a positive effect with a reduction in HADS anxiety score following participation. Having established the feasibility of this programme, a RCT of the programme vs. standard care is planned. Clinical trial information: ISRCTN77608320. [Table: see text]