The Sexual Health of Rectal Cancer Patients

NCT00712751 | Completed

• 1 other identifier: 08-073
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 2

Brief Summary

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

Rectal Cancer; Rectum

Keywords

Rectum; Quality of Life; Sexual Health; 08-073

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of study

Secondary Outcomes (2)

• 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.

  conclusion of study

• To explore baseline variables that may influence the effectiveness of CSI-SH (i.e., moderators such as socio-demographic and medical variables).

  conclusion of study

Study Arms (2)

1

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

Behavioral: questionnaires

2

Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus Usual Care (US)

Behavioral: CSI-SH- Cancer Survivorship Intervention

Interventions

questionnaires BEHAVIORAL

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.

1

CSI-SH- Cancer Survivorship Intervention BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Albert Einstein College of Medicine: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• M.D. Anderson Cancer Center: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 38389458 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christian Nelson, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 10, 2008
• Study Start: June 24, 2008
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

US (2)