Clinical trial NCT00712751: The Sexual Health of Rectal Cancer Patients
Official title: The Sexual Health of Rectal Cancer Patients: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Rectum
Keywords: Rectum
Quality of Life
Sexual Health
08-073
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Icahn School of Medicine at Mount Sinai
name: M.D. Anderson Cancer Center
name: National Institutes of Health (NIH)
First posted: 2008-07-10
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colorectal patients

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).

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: conclusion of study
Secondary outcomes:
measure: 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.
timeFrame: conclusion of study
measure: To explore baseline variables that may influence the effectiveness of CSI-SH (i.e., moderators such as socio-demographic and medical variables).
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: