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The Sexual Health of Rectal Cancer Patients: A Pilot Study


N/A
21 Years
N/A
Open (Enrolling)
Both
Rectal Cancer, Rectum

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Trial Information

The Sexual Health of Rectal Cancer Patients: A Pilot Study


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).


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Katherine DuHamel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-073

NCT ID:

NCT00712751

Start Date:

June 2008

Completion Date:

June 2014

Related Keywords:

  • Rectal Cancer
  • RECTUM
  • Rectum
  • Quality of Life
  • Sexual Health
  • 08-073
  • Rectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mount Sinai HospitalNew York, New York  10029