The Sexual Health of Rectal Cancer Patients - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Albert Einstein College of Medicine of Yeshiva University Mount Sinai School of Medicine M.D. Anderson Cancer Center National Institutes of Health (NIH)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00712751

Purpose

We know that treatment for rectal cancer can impact sexual function. This study aims to learn:

How the treatment affects emotional and social well-being.
How a new sexual health counseling program affects you.

Cancer patients seek counseling 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 cancer.

It involves a new type of counseling. 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 counseling with the standard care patients receive after treatment for rectal cancer.

Condition	Intervention
Rectal Cancer Rectum	Behavioral: questionnaires Behavioral: CSI-SH- Cancer Survivorship Intervention

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Sexual Health of Rectal Cancer Patients: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	160
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 usual care (UC) which is the standard care that patients receive	Behavioral: questionnaires 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 therapy 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 2 and 4 months after baseline.
2 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 one and two will be done face-to-face and rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions. Participants will have the option to complete sessions in person or over the phone .

Groups/Cohorts

Assigned Interventions

1

usual care (UC) which is the standard care that patients receive

Behavioral: questionnaires

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 therapy 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 2 and 4 months after baseline.

2

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 one and two will be done face-to-face and rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions. Participants will have the option to complete sessions in person or over the phone .

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Colorectal patients

Criteria

Inclusion Criteria:

Had surgery for stage I-III rectal adenocarcinoma or colon cancer with an anastomosis at 15 cm or below at MSKCC
Have no evidence of disease or recurrence
Are two or more years post rectal cancer treatment at MSKCC
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?" In the judgment of the consenting professional, able to communicate in English well enough to work with English speaking therapists and complete the study assessments.
Age 21 years or older.
For men only: married or in a committed relationship

Exclusion Criteria:

Participant determined geographical inaccessibility to attend therapy sessions.
Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712751

Contacts

Contact: Katherine DuHamel, PhD		duhamelk@mskcc.org
Contact: Jeanne Carter, PhD		carterj@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Katherine DuHamel, PhD duhamelk@mskcc.org
Contact: Jeanne Carter, PhD carterj@mskcc.org
Principal Investigator: Katherine DuHamel, PhD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Albert Einstein College of Medicine of Yeshiva University

Mount Sinai School of Medicine

M.D. Anderson Cancer Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Katherine DuHamel, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Katherine DuHamel, PhD )
Study ID Numbers:	08-073
Study First Received:	July 7, 2008
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00712751 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Rectum
Quality of Life
Sexual Health

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm

Quality of Life
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009