Rectal Cancer Clinical Trial
Official title:
The Sexual Health of Rectal Cancer Patients: A Pilot Study
NCT number | NCT00712751 |
Other study ID # | 08-073 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2008 |
Est. completion date | June 2024 |
Verified date | July 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn: - How the treatment affects emotional and social well-being. - How a new sexual health educational program affects you. Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.
Status | Active, not recruiting |
Enrollment | 192 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - At least six months post radiation and/or surgery for stage I-III rectal adenocarcinoma or rectosigmoid for cancer with an anastomosis at 15 cm or below and completed treatment - At least six months post radiation and/or chemotherapy for anal cancer. - Have no evidence of disease or recurrence - For women indicate Indicate moderate satisfaction or below on their overall sexual life (a score of "4" or lower on the question "Over the past 4 weeks, how satisfied have you been with your overall sexual life?" - For men indicate, and a score of "3" or lower on the question "How would you rate your confidence that you could get and keep an erection" for men) and a score of "2" or higher on the question "How much does this problem bother you? - In the judgment of the consenting professional interventionists, able to communicate in English well enough to work with English speaking and complete the study assessments. - Age 21 years or older. Exclusion Criteria: - Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention. - Are actively participating in protocol 06-151 - Participated in focus group or qualitative interview. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Albert Einstein College of Medicine, Icahn School of Medicine at Mount Sinai, M.D. Anderson Cancer Center, National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the feasibility, tolerability, acceptability (including adherence) and efficacy of CSI-SH, a psycho-educational intervention, on the primary outcome of sexual functioning among RC survivors. | conclusion of study | ||
Secondary | To investigate the impact of CSI-SH on secondary outcomes: sexual self-schema, cancer specific distress, general distress symptoms, and Quality of Life for all participants, as well as sexual bother for men only. | conclusion of study | ||
Secondary | To explore baseline variables that may influence the effectiveness of CSI-SH (i.e., moderators such as socio-demographic and medical variables). | conclusion of study |
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