The Sexual Health of Rectal Cancer Patients

Completed

Interventions: Behavioral: questionnaires
Behavioral: CSI-SH- Cancer Survivorship Intervention

Brief Summary: 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.

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).

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
1	questionnaires	usual care (UC) which is the standard care that patients receive
2	CSI-SH- Cancer Survivorship Intervention	Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Locations (2): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Mount Sinai Hospital
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New York, New York, United States

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