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The Sexual Health of Rectal Cancer Patients

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Rectum
Rectal Cancer

Treatments

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

Study type

Observational

Funder types

Other
NIH

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

192 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

192 participants in 2 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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