Clinical trial · Observational
The Sexual Health of Rectal Cancer Patients
The Sexual Health of Rectal Cancer Patients: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectum | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSI-SH- Cancer Survivorship Intervention | Behavioral | — | UNRESOLVED |
| questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- usual care (UC) which is the standard care that patients receive
- interventionNames
- Behavioral: questionnaires
- label
- 2
- description
- Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)
- interventionNames
- Behavioral: CSI-SH- Cancer Survivorship Intervention
Primary outcomes (4)
- measure
- Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1
- timeFrame
- 4 months post-baseline (follow-up 1)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNelson 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. PMID 38389458