Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anxiety, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Psychiatric, Women's Studies, Women's Studies, Endometrial Cancer |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/12/2016 |
| Start Date: | September 2014 |
| End Date: | September 2016 |
Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
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.
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.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of patient recruitment, including time required to consent,
enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient‐reported outcome measures,
including time to resumption of sexual activity, global satisfaction with sex life, sexual
function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most
effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week
post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted
sexual health intervention at the 2-4 week post-operative visit.
ARM III: 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.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at
both the pre-operative and 2-4 week post-operative visit.
I. To evaluate the feasibility of patient recruitment, including time required to consent,
enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient‐reported outcome measures,
including time to resumption of sexual activity, global satisfaction with sex life, sexual
function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most
effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week
post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted
sexual health intervention at the 2-4 week post-operative visit.
ARM III: 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.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at
both the pre-operative and 2-4 week post-operative visit.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
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