The Sexual Health of Rectal Cancer Patients
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Mount Sinai School of Medicine
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00712751
First received: July 7, 2008
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rectal Cancer Rectum |
Behavioral: questionnaires Behavioral: CSI-SH- Cancer Survivorship Intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Sexual Health of Rectal Cancer Patients: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To explore baseline variables that may influence the effectiveness of CSI-SH (i.e., moderators such as socio-demographic and medical variables). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 192 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
usual care (UC) which is the standard care that patients receive
|
Behavioral: questionnaires
Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling 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 4 and 8 months after baseline.
|
|
2
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
|
Behavioral: CSI-SH- Cancer Survivorship Intervention
This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
|
Detailed Description:
This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer.
We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Colorectal patients
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712751
Contacts
| Contact: Katherine DuHamel, PhD | 646-888-0032 | |
| Contact: Jeanne Carter, PhD | 646-888-5076 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Katherine DuHamel, PhD 646-888-0032 | |
| Contact: Jeanne Carter, PhD 646-888-5076 | |
| Principal Investigator: Katherine DuHamel, PhD | |
| Mount Sinai Hospital | Active, not recruiting |
| New York, New York, United States, 10029 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Albert Einstein College of Medicine of Yeshiva University
Mount Sinai School of Medicine
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Katherine DuHamel, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00712751 History of Changes |
| Other Study ID Numbers: | 08-073 |
| Study First Received: | July 7, 2008 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Rectum Quality of Life Sexual Health 08-073 |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013