Male rectal and anal cancer patients demonstrate high rates of sexual dysfunction. This pilot randomized controlled trial tested a psychoeducational intervention designed to improve psychosexual adjustment.

Rectal or anal cancer patients were randomized to a Sexual Health Intervention for Men (intervention) or to a referral and information control (control). The intervention included control activities plus 4 sexual health intervention sessions every 4–6 weeks and 3 brief telephone calls timed between these sessions. Assessments were completed pre-intervention (baseline) and 3 months (follow-up 1) and 8 months (follow-up 2) post-intervention. Differences were assessed with statistical significance and Cohen’s d effect sizes (d = 0.2, small effect; d = 0.5, moderate effect; d = 0.8, large effect).

Ninety subjects enrolled. Forty-three participants completed at least 1 follow-up assessment (intervention, n = 14; control n = 29). At follow-up 1, men in intervention, compared to control, improved on all domains of the International Index of Erectile Function (IIEF) (p < 0.001 to p < 0.05) and demonstrated large effects (d = 0.8 to d = 1.5). Similarly, at follow-up 2, changes in all domains of the IIEF except the orgasm domain were either statistically significant or marginally statistically significant (p = 0.01 to p = 0.08) and demonstrated moderate to large treatment effects for intervention versus control (d = 0.5 to d = 0.8). Men in the intervention, compared to control, demonstrated decreased sexual bother at follow-up 1 (p = 0.009, d = 1.1), while Self-Esteem and Relationship (SEAR) total scores and the SEAR sexual relationship subscale demonstrated moderate increases for intervention versus control (d = 0.4 to d = 0.6).

This study provides initial evidence for combining a psychoeducational intervention with medical interventions to address sexual dysfunction following rectal and anal cancer. Trials register number: NCT00712751 (date of registration: 7/10/2008).

To assess the feasibility of a randomised controlled trial (RCT) on patients receiving radical radiotherapy for carcinoma of the anus in order to compare the present skincare advice at the time of the study with an alternative product, Aveeno, used primarily for dermatological and chemotherapeutic-induced skin conditions.

Standardised Radiation Therapy Oncology Group (RTOG) grading and skincare assessments were used primarily to inform on physical reactions within a RCT. A pre-existing morbidity/quality-of-life instrument ‘the Head and Neck Radiotherapy Questionnaire’, which was validated for use with radiotherapy patients in preceding studies, was adapted for anus patients and formed the secondary basis for data collection. In all, 24 participants undergoing radical radiotherapy for anal cancer were randomised into two arms, Aveeno cream versus Aqueous Cream BP, and reviewed weekly to collect data and perform analysis and Mann–Whitney U non-parametric statistical tests.

RTOG gradings for skin reactions were comparable week by week across the cohorts, with a baseline 100% of participants exhibiting RTOG 0 at week 1 in all areas, through to week 6 where both cohorts had progressed to higher RTOG grades. The Aveeno cohort, however, indicated a p-value approaching significance in regards to epidermal regeneration at follow-up 1 (p=0·0543). Questionnaires yielded diminishing responses as treatment progressed correlating with advancing RTOG grades, and exhibited increasing negativity in responses in correlation with advancing RTOG grade exhibited.

The study was the first to recognise colloidal oatmeal as a skincare approach in the radiotherapy setting and recognises the potential benefits of Aveeno in radiation-induced skin reactions. The study determined the RTOG grading system to be robust as a method of evaluation of skin reactions and the questionnaires deemed the quality-of-life assessment to be a necessity in order to address patients’ psychological needs in addition to the physical needs.