Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

NCT02096783 | Completed

• 6 other identifiers: UW13080NCI-2014-00471P30CA0145202014-0122A532820SMPH/OBSTET & GYNECOL/OBSTET
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

Conditions

Anxiety Disorder; Cervical Cancer; Endometrial Cancer; Female Reproductive Cancer; Gestational Trophoblastic Tumor; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Sexual Dysfunction; Uterine Sarcoma; Vaginal Cancer; Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of patient recruitment

  To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.

  Up to 9 months

Secondary Outcomes (7)

• Resumption of sexual activity after cancer surgery

  Up to 9 months

• Retention

  Up to 9 months

• Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire

  Up to 9 months

• PROMIS Sexual Function Profile

  Up to 9 months

• Recall of intervention

  Up to 9 months

Study Arms (4)

Arm I (standard counseling)

ACTIVE COMPARATOR

Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.

Other: counseling intervention; Other: questionnaire administration

Arm II (standard counseling, scripted intervention)

EXPERIMENTAL

Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.

Other: informational intervention; Other: counseling intervention; Other: questionnaire administration

Arm III (standard counseling, scripted intervention)

EXPERIMENTAL

Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.

Other: informational intervention; Other: counseling intervention; Other: questionnaire administration

Arm IV (standard counseling, scripted intervention)

EXPERIMENTAL

Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Other: informational intervention; Other: counseling intervention; Other: questionnaire administration

Interventions

informational intervention OTHER

Given scripted intervention

Arm II (standard counseling, scripted intervention); Arm III (standard counseling, scripted intervention); Arm IV (standard counseling, scripted intervention)

counseling intervention OTHER

Given standard counseling

Also known as: counseling and communications studies

Arm I (standard counseling); Arm II (standard counseling, scripted intervention); Arm III (standard counseling, scripted intervention); Arm IV (standard counseling, scripted intervention)

questionnaire administration OTHER

Ancillary studies

Arm I (standard counseling); Arm II (standard counseling, scripted intervention); Arm III (standard counseling, scripted intervention); Arm IV (standard counseling, scripted intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a new suspected or confirmed gynecologic malignancies
• Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
• Patients must be English speaking

You may not qualify if:

• Previous treatment of any cancer excluding skin cancer
• Patients with a suspected benign gynecologic process
• Patients who are prisoners or incarcerated

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Anxiety Disorders; Uterine Cervical Neoplasms; Endometrial Neoplasms; Gestational Trophoblastic Disease; Carcinoma, Ovarian Epithelial; Sexual Dysfunction, Physiological; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Mental Disorders; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Pregnancy Complications, Neoplastic; Pregnancy Complications; Carcinoma; Neoplasms, Glandular and Epithelial; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Kushner

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: November 18, 2019

Record last verified: 2016-11

Locations

US (1)