Psychological Interventions for Gynecologic Cancer

Not Applicable

Completed

• Conditions: Gynecologic Cancer
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT01951807
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

Subjects that have received medical treatment for ovarian cancer can be both physically and emotionally demanding for patients. The purpose of this study is to determine whether two common pyschological interventions (Communication Skills Intervention and Supportive Counseling) may improve the well-being of ovarian cancer patients compared to usual care.

Detailed Description

Very little is known in the psycho-oncology literature about why psychological interventions are effective or for how long these interventions exert an impact. Given many cancer patients experience recurrence and/or progression, it is important to know whether our relatively brief interventions facilitate how patients cope with this most-feared medical event. From a theoretical perspective, the study will advance our understanding of the mechanisms for change for two common treatment approaches, supportive and cognitive behavioral therapies.

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Primary Completion: 2017-07-19
• Study Completion: 2017-07-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 375

Inclusion Criteria

• Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Coping & Communication Skills	Psychotherapy	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.
Supportive Counseling (SC)	Psychotherapy	The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions

Primary Outcome Measures

Name	Time	Method
Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation	7 years	Global Psychological distress: Depressive symptoms - The BDI is a 21-item scale which has been widely used in studies incorporating cognitive-behavioral interventions.The MHI-18 has subscales for Psychological Distress and Well-being.
Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation	7 years	Cancer-Specific Distress: Traumatic Stress. The Impact of Events Scale (IES) is a 15-item self-report measure focusing on intrusive and avoidant ideation related to gynecologic cancer and its treatment. Using a 4-point Likert scale, participants rated how true each statement has been for them during the past week (scale range = 0-75).; Fear of Recurrence/Progression. The Concerns about Recurrence Scale (CARS) is a 26 item assessment of the nature of women's fears about cancer recurrence.
Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life	7 years	Quality of Life-General. The Functional Assessment of Cancer Therapy - General (FACT-G) is a widely used measure of QOL. The FACT-G is comprised of 27 questions that assess well-being in four domains: physical, functional, social/family, and emotional.; Spiritual well-being. The FACIT Spiritual well-being scale assesses a sense of meaning in life, harmony, peacefulness, sense of strength, and comfort from one's faith. The 12 item scale has two factors: Meaning/Peace and Faith.

Trial Locations

Locations (9)

Cancer Institute of New Jersey at Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Cooper Health System; 🇺🇸 Camden, 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

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States