Psychological Interventions for Gynecologic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Behavioral: Psychotherapy

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 Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System
    • Hamilton, New Jersey, United States, 08690
      • Cancer Institute of New Jersey at Hamilton
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University School of Medicine
    • Philadelphia, Pennsylvania, United States, 19111
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Psychotherapy
Experimental: Supportive Counseling (SC); The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions	Behavioral: Psychotherapy
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation	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.	7 years
Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation	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.	7 years
Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life	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.	7 years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 19, 2017
• Study Completion (Actual): July 19, 2017

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Coping; Psychosocial Effects of Cancer and Treatment
• Other Study ID Numbers: 130909; R01CA085566-06A1 (U.S. NIH Grant/Contract); NCI-2012-00551 (Other Identifier: CTRP (Clinical Trails Reporting Program))