NCT00712751|CompletedResults
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Sponsor study identifier
observational
149
1 country
2
Study Start
June 24, 2008
Actual (reported)Primary Completion
November 21, 2024
Actual (reported)Study Completion
November 21, 2024
Actual (reported)We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 21, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2008
Actual (reported)July 7, 2008
Actual (reported)July 10, 2008
Actual (reported)November 21, 2024
Actual (reported)November 21, 2024
Actual (reported)August 26, 2026
Actual (reported)Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
4 months post-baseline (follow-up 1)
Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2
The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0
8 months post-baseline (follow up 2)
Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1
4 months post-baseline (follow up 1)
Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2
8 months post-baseline (follow up 2)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1
4 months post-baseline (follow up 1)
Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2
8 months post-baseline (follow up 2)
Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1
4 months post-baseline (follow up 1)
usual care (UC) which is the standard care that patients receive
Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
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 counseling 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 4 and 8 months after baseline.
Colorectal patients
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Nelson CJ, Schuler TA, Reiner AS, Baser RE, Demirjian CC, Mulhall J, Temple L, Schover L, Jandorf L, DuHamel KN. A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study. Palliat Support Care. 2024 Feb 23:1-9. doi: 10.1017/S1478951523001906. Online ahead of print.
Christian Nelson, PhD
Memorial Sloan Kettering Cancer Center
149 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2008
First Posted
July 10, 2008
Study Start
June 24, 2008
Actual (reported)Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations
4 months post-baseline (follow up 1)
Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2
The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.
8 months post-baseline (follow-up 2)
This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 21, 2024
Actual (reported)Study Completion
November 21, 2024
Actual (reported)Last Updated
August 26, 2026
Results First Posted
August 26, 2026
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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