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
NA
375 participants
INTERVENTIONAL
2010-06-30
2017-07-19
Brief Summary
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Detailed Description
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Subjects will be enrolled and upon completion of a baseline survey, randomized to into one of three arms - Communication Skills Intervention, Supportive Counseling, and Usual Care. Subjects will complete surveys during the course of the interventions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Coping & Communication Skills
The CCI intervention focuses on bolstering stress management and problem solving abilities, identifying and expressing support needs constructively, facilitating the ability to cope with unchangeable issues, cognitive restructuring, and dealing effectively with body image and sexuality issues over seven weekly 60 minute sessions.
Psychotherapy
Supportive Counseling (SC)
The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions
Psychotherapy
Usual Care (UC)
Patients receive standard psychological and emotional care (usual care \[UC\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).
No interventions assigned to this group
Interventions
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Psychotherapy
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with High Grade Stage 2, any grade Stage 3 or higher endometrial cancer in the past 6 months
* Newly diagnosed with Stage 2 or higher cervical cancer withing the past 6 months
* Newly diagnosed with any stage of Uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
* At the time of recruitment, the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
* At the time of recruitment, a Karnofsky Performance Status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* English speaking
* Lives within a two-hour commuting distance from the recruitment site
* No hearing impairment
* Has signed consent within 6 months of diagnosis date
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers Cancer Institute of New Jersey
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Locations
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Cooper Health System
Camden, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Jefferson University School of Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2012-00551
Identifier Type: OTHER
Identifier Source: secondary_id
130909
Identifier Type: -
Identifier Source: org_study_id