The Sexual Health of Rectal Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00712751|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2008
Last Update Posted : July 6, 2017
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 or disease||Intervention/treatment|
|Rectal Cancer Rectum||Behavioral: questionnaires Behavioral: CSI-SH- Cancer Survivorship Intervention|
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).
|Study Type :||Observational|
|Estimated Enrollment :||192 participants|
|Official Title:||The Sexual Health of Rectal Cancer Patients: A Pilot Study|
|Actual Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
usual care (UC) which is the standard care that patients receive
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.
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.
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712751
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Katherine DuHamel, PhD||Memorial Sloan Kettering Cancer Center|