Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 6/1/2018 |
| Start Date: | October 2010 |
| End Date: | June 1, 2017 |
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
This randomized phase II trial studies how well psychosexual intervention works in patients
with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual
and psychosocial function.
with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual
and psychosocial function.
PRIMARY OBJECTIVES:
I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a
phase II randomized clinical trial (RCT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention
comprising stress reduction, information delivery regarding gynecologic or breast cancer
treatments and sexuality, and provision of a survivorship care plan (SCP) created using
OncoLink over 1 hour following baseline assessment and before 6 months.
ARM II (Psychological intervention): Patients participate in individual or group therapy over
1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete
assessment interviews.
After completion of study treatment, patients are followed up at 3, 6, and 9 months.
I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a
phase II randomized clinical trial (RCT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention
comprising stress reduction, information delivery regarding gynecologic or breast cancer
treatments and sexuality, and provision of a survivorship care plan (SCP) created using
OncoLink over 1 hour following baseline assessment and before 6 months.
ARM II (Psychological intervention): Patients participate in individual or group therapy over
1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete
assessment interviews.
After completion of study treatment, patients are followed up at 3, 6, and 9 months.
Inclusion Criteria:
- Stage I-III gynecologic (any site) or breast cancer
- Able to speak/read English
- Able to give informed consent
Exclusion Criteria:
- Prior non-gynecologic/breast cancer diagnosis
- Refusal of any cancer treatment(s)
- Non-ambulatory
- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or
significant sensory deficit
- Major mental illness (e.g, schizophrenia, major depressive disorder)
- Current/recent (prior 12 months) pregnancy
- Residence > 70 miles from research site
We found this trial at
1
site
300 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(800) 293-5066
Principal Investigator: Carpenter Kristen, Ph.D
Phone: 614-685-8754
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
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