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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Albert Einstein College of Medicine of Yeshiva University Mount Sinai School of Medicine National Cancer Institute (NCI) |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00712751 |
We know that treatment for rectal cancer can impact women's sexual function. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to women who have been treated for rectal cancer. It involves a new type of counseling. It will teach women 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 counseling with the standard care women receive after treatment for rectal cancer.
Condition | Intervention |
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Rectal Cancer Rectum |
Behavioral: questionnaires Behavioral: CSI-SH- Cancer Survivorship Intervention |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Sexual Health of Rectal Cancer Patients: A Pilot Study |
Estimated Enrollment: | 80 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
usual care (UC) which is the standard care that patients receive
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Behavioral: questionnaires
Participants randomized to the Usual Care arm will receive standard care (the care that participants receive who are not in the intervention). These individuals will not receive any additional therapy sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 2 and 4 months after baseline.
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2
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
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Behavioral: CSI-SH- Cancer Survivorship Intervention
This involves four 1-hour face-to-face individual sessions with three additional telephone booster/review sessions provided in between the four face-to-face sessions.The face-to-face sessions also include homework assignments that will be reviewed at the subsequent session. Topics covered in the face-to-face sessions are reviewed in the booster telephone calls with the participant the following week. These telephone calls serve as a practice reminder for the participant as well as to help the participant reduce any barriers to implementing the session strategies and/or homework.
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Colorectal patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Katherine DuHamel, PhD | duhamelk@mskcc.org | |
Contact: Jeanne Carter, PhD | carterj@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Katherine DuHamel, PhD duhamelk@mskcc.org | |
Contact: Jeanne Carter, PhD carterj@mskcc.org | |
Principal Investigator: Katherine DuHamel, PhD |
Principal Investigator: | Katherine DuHamel, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Katherine DuHamel, PhD ) |
Study ID Numbers: | 08-073 |
Study First Received: | July 7, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00712751 |
Health Authority: | United States: Institutional Review Board |
Rectum Quality of Life Sexual Health |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Quality of Life Gastrointestinal Neoplasms |
Intestinal Diseases Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Rectal neoplasm |
Neoplasms Neoplasms by Site |