Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
NCT ID: NCT01764802
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2010-10-31
2017-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (enhanced standard care)
Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.
behavioral, psychological or informational intervention
Participate in enhanced standard care
Arm II (psychological intervention)
Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
behavioral, psychological or informational intervention
Participate in psychological intervention
Interventions
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behavioral, psychological or informational intervention
Participate in enhanced standard care
behavioral, psychological or informational intervention
Participate in psychological intervention
Eligibility Criteria
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Inclusion Criteria
* Able to speak/read English
* Able to give informed consent
Exclusion Criteria
* 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
21 Years
80 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Kristen Carpenter
Principal Investigator
Principal Investigators
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Kristen M. Carpenter, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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Black LL, Conroy K, Lustberg M, Salani R, Andersen BL, Carpenter KM. Association of sexual pain and psychological factors among gynecologic and breast cancer patients: application of components of the fear-avoidance model of chronic pain. J Behav Med. 2025 Jun;48(3):536-543. doi: 10.1007/s10865-025-00560-3. Epub 2025 Mar 13.
Related Links
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Jamesline
Other Identifiers
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NCI-2012-01341
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-10077
Identifier Type: -
Identifier Source: org_study_id
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