Sexual dysfunction is one of the most prevalent and persistent problems after cancer treatment. This Fast Track STTR will create and evaluate a multimedia educational and counseling tool to promote recovery of sexual satisfaction in men treated for cancer. Second Manhood: Recovering Your Sex Life after Cancer will be viewable over the internet, on a CD or DVD, or in printed form. It will help men understand how cancer treatments cause sexual problems, learn self-help strategies to improve sexual function, and optimize use of medical treatments. Partners will get advice, self-help exercises, and communication skills training to enhance their role in resolving sexual problems. For health care professionals, we are creating the Follow-Through System for Male Sexual Dysfunction (FT) to improve the quality and continuity of care. It will provide scheduled assessments, using Interactive Voice Recording (IVR) telephony. Scheduled symptom reports with rapid responses from the clinic staff should enhance the success of treatments for erectile dysfunction, preventing the common problem of men discontinuing a prescribed treatment, and then giving up. Phase I:
Aim 1 is to use focus groups and interviews to tailor the text and video vignette components of Second Manhood (SM) to a diverse audience. We will assess 130 cancer survivors of varying ethnicity, sexual orientation, age, relationship status, and cancer history.
Aim 2 is to use interviews with expert health care professionals (HCP's) to design and create the FT communication interface, pilot testing it in our Sexual Medicine Clinic at UT M. D. Anderson Cancer Center. A communication skills manual for HCP's will also be created. Phase II: We will recruit 360 men from this clinic and from a county hospital. All will be cancer survivors with no current evidence of disease, off active treatment, and seeking help for sexual dysfunction. Partners will be encouraged to participate. We will use adaptive randomization to assign men to one of three groups: Usual Care in the Sexual Medicine clinic (UC), UC + SM, or UC + SM + FT. Those receiving SM will be instructed to view and interact with the application and carry out behavioral homework. All men will complete a brief questionnaire on symptoms via the IVR at baseline, 12 weeks, and 24 weeks. The IVR will call FT group men and partners at 2, 4, 6, and 8 weeks to complete the Treatment Satisfaction Scale (TSS). FT group members will also be encouraged to initiate calls with questions or problems. A mid-level practitioner hired for the study will follow both SM groups. Men will complete additional brief questionnaires at baseline, 12 and 24 weeks assessing overall distress, marital satisfaction, quality of life, and a broad spectrum of sexual function. The hypothesis is that improvements in sexual function and satisfaction will be significantly greater at follow-up for the SM and SM + FT groups than the UC group, but the FT group will also have significantly better outcomes than the SM group. Partner participation and extent of website usage may be moderating variables. All participants will complete a program evaluation form at week 24. During Phase II an IVR-based Sexual Medicine Hotline will be piloted to facilitate both self- and HCP referrals to the Sexual Medicine Clinic.

Public Health Relevance

According to the office of Cancer Survivorship, about 3,050,000 men in the United States are survivors of prostate, colorectal, or bladder cancer, which means at least 1,525,000 suffer from cancer-related sexual dysfunction. Research indicates that less than 20 percent of men end up satisfied with their recovery from sexual problems, even though 60 percent are distressed about them, and most try some type of medical help. Second Manhood provides education and counseling using multimedia technology to help men and their partners resolve cancer-related sexual dysfunction. A companion product, the Follow-Through System for Male Sexual Dysfunction uses Interactive Voice Recording (IVR) telephony to improve the consistency and quality of medical care for sexual problems.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
1R42CA139822-01A1
Application #
7800679
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Evans, Gregory
Project Start
2009-09-28
Project End
2010-08-31
Budget Start
2009-09-28
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
$179,333
Indirect Cost
Name
Digital Science Technologies, LLC
Department
Type
DUNS #
803589089
City
Washington Crossing
State
PA
Country
United States
Zip Code
18977