MDACC Study Summary 2009-0350

Study Summary
No. 2009-0350:.......Bladder; Blood And Marrow Transplantation; Colorectum; Genitourinary; Head And Neck; Leukemia; Lymphoma; Prostate; Sarcoma; Testis......Leslie R. Schover......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0350

Study Title:	Second Manhood: A Multimedia Intervention for Male Sexual Problems after Cancer

Physician

New Patient Referral



Name:	Leslie R. Schover	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2681 Contact us about clinical trials

General Information



Disease Group:	Bladder Blood And Marrow Transplantation Colorectum Genitourinary Head And Neck Leukemia Lymphoma Prostate Sarcoma Testis	Supported By:	National Cancer Institute Small Business Grants (approval pending)

Phase of Study:	Phase II	Return Visit:	At least once for their evaluation in the Sexual Medicine Clinic. Further in-person follow-up visits would be determined by their treatment needs in that clinic, not by our research, which is internet-based and phone-based.

Treatment Agents:	Cognitive Behavioral Therapy Focus Group	Home Care:	None, except by computer or phone.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	No stay is involved.


Description/ Intervention:	The goal of Phase 1 of this research study is to learn more about the experiences of a diverse group of men who are trying to resolve cancer-related sexual problems. Researchers also want to learn if men find a new computerized sexual counseling program easy to use, helpful to their needs, and sensitive to different cultures.

Study Objectives / Outcomes

The 6 months of Phase I will have two objectives:
1. To gather information that will enable us to tailor the patient and partner components of Second Manhood to enhance its efficacy with specific groups, using qualitative research methodologies.
2. To create and pilot the Follow-Through communication interface for health care professionals and patients.
The specific objectives of the 2.5 years of Phase II are: To create and evaluate the application Second Manhood for men who have cancer-related sexual dysfunction and their partners, and the supplemental Follow-Through System for MSD and communication skills training modules for health care professionals and peer counselors.

Study Status Information



Study Activation / Registration Date:	05/13/2010

IRB Review and Approval Date:	05/13/2010

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	850

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Phase I Qualitative Research: Male who has had cancer treatment and is currently age18 or older.

2) Phase 1 Qualitative Research: History of prostate, bladder, colorectal, testis, or head and neck cancer, or of sarcomas, lymphomas, or leukemias. These are the sites for men that were most common in our Needs Assessment survey on services for sexual dysfunction. For Phase I, survivors of pediatric and adolescent cancer can also be included.

3) Phase 1 Qualitative Research: Participants must be able to speak or read English well enough to understand the application and respond accurately to questionnaires or interview assessments.

4) Phase II Randomized Trial: Participants must be males with a history of cancer treatment who are at least 18 years old, or the sexual partner of a participant.

5) Phase II Randomized Trial: Participants must be survivors of prostate, bladder, colorectal, testis, or head and neck cancer, penile cancer, or of sarcomas, lymphomas, or leukemias.

6) Phase II Randomized Trial: Men must be currently free of known cancer, and off active treatment.

7) Phase II Randomized Trial: Men must have a sexual relationship of at least 6 months' duration to maximize the chance that they will have a sexual partner available during their 6-month participation in the study.

8) Phase II Randomized Trial: Participants will be asked to invite their partner to participate. If the partner agrees, s/he will complete a separate informed consent process and will have a unique study identification number. S/he will participate in behavioral homework, complete the Partner version of the Treatment Satisfaction Scale at each assessment point and her/his usage of the website will be electronically recorded.

9) Phase II Randomized Trial: Participants need to have access to the internet at home or in another routinely accessible, private location, although we do currently have 10 notebook computers with CD-ROM drives that are available for loan, and we could subsidize internet access in case of need.

10) Phase II Randomized Trial: Participants and participating partners must be able to read English well enough to comprehend Second Manhood.

11) Phase II Randomized Trial: Patients need to be seeking help for erectile dysfunction in the Male Sexual Medicine Clinic at UTMDACC, or be referred from our urologic oncology clinic at Lyndon B. Johnson Hospital. Men who are having penile prosthesis surgery will begin the baseline assessment at 6-8 weeks post-surgery, so that they are ready to resume sexual activity.

12) Phase II Randomized Trial: Patient meets the scoring criterion for sexual dysfunction on the Treatment Satisfaction Scale, and if he is currently using a physiological treatment for erectile dysfunction, is not satisfied with the treatment.

Exclusion Criteria:

1) None.

Links

Registration Number: Not Applicable Clinical Trial