Author(s)
Charlene Joanne Bryan, PhD, MPH, Post Doctoral Fellow1, Jennifer L James, MS, Biostatistician2, Thomas M Pisansky, MD, Professor of Radiation Oncology3, Thomas Corbett, MD, Radiation Oncologist4, Naresh Jha, MD, Radiation Oncologist5, Robert Swanson, MD, Radiation Oncologist6, Alan Hartford, MD, PhD, Radiation Oncologist7, Howard Sandler, MD, Professor, Department of Radiation Oncology and Department of Urology8, Lawrence Berk, MD, PhD, Medical Director9, Lisa Kachnic, MD, Associate Director10, Deborah Watkins Bruner, RN, PhD, Independence Professor of Nursing Education, Director, Recruitment, Retention and Outreach Core Facility11University of Pennsylvania, School of Nursing, Philadelphia, PA, USA; 2 Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA, USA; 3 Mayo Clinic, Rochester, MN, USA; 4 Juravinski Cancer Centre, Hamilton, ON, Canada; 5 Cross Cancer Institute, Edmonton, AB, Canada; 6 Natalie Warren Bryant Cancer Center, Tulsa, OK, USA; 7 Dartmouth Hitchcock Medical Center, Lebanon, NH, USA; 8 University of Michigan, Ann Arbor, MI, USA; 9 H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA; 10 Boston University Medical Center, Boston, MA, USA
Objective: Radiation Therapy Oncology Group (RTOG) study 0215 was a placebo-controlled, double-blind, cross-over trial of sildenafil given after radiotherapy and neoadjuvant/concurrent short-term androgen suppression. Sildenafil improved erectile function amongst participants. We now report on the study goal to investigate the effect of sildenafil on marital and sexual adjustment for participants and their partners. Methods: RTOG 0215 closed before meeting its desired accrual goal with enrollment of 111 eligible patients (72 married). Twenty-four patients (mean age: 72.6 ± 6.8y) and their married partners (mean marriage duration: 37.2 ± 16.3y) completed the self-report assessments of erectile function and of marital and sexual adjustment using the validated measures of the Locke's Marital Adjustment Test (LMAT) and the Sexual Adjustment Questionnaire (SAQ). Statistical differences in and correlations between the change in LMAT and SAQ scores were tested for significance from placebo to sildenafil. Results: There was no significant change in LMAT scores for either patients (p=0.37) or partners (p= 0.35). The change in patient SAQ score was statistically significant, but not clinically meaningful (D=2.58, p=0.02), while partners reported a smaller change in SAQ score (D=1.47, p=0.47). The correlations between patient and partner LMAT change scores (?=0.40, p=0.09) and SAQ change scores (?=0.15, p=0.48) were non-significant. Patient LMAT and SAQ change scores (?=0.38, p=0.08) were not significantly correlated. However, the partner LMAT and SAQ change scores (?=0.45, p=0.04) were significantly correlated. Conclusion: Erectile dysfunction (ED) affects, and is affected by, the patient, their partner and the relationship. ED treatment appears to significantly influence female partner sexual adjustment and marital adjustment. These results are tentative and should be considered as an exploratory basis for a larger clinical trial. The small sample size may have precluded detection of important other endpoints, which should not be excluded from future investigations.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PCN76
Topic
Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods
Disease
Oncology
