Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychological Interventions for Gynecologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951807
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Behavioral: Psychotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological Interventions for Gynecologic Cancer
Study Start Date : June 2010
Actual Primary Completion Date : July 19, 2017
Actual Study Completion Date : July 19, 2017

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).



Primary Outcome Measures :
  1. Do the two psychological interventions, CCI and SC, result in greater improvements in global psychological adaptation [ Time Frame: 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.


  2. Do the two psychological interventions, CCI and SC, result in greater improvements in cancer-specific psychological adaptation [ Time Frame: 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.


  3. Do the two psychological interventions, CCI and SC, result in greater improvements in quality of life [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951807


Locations
Layout table for location information
United States, New Jersey
Cooper Health System
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
United States, Pennsylvania
Jefferson University School of Medicine
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01951807    
Other Study ID Numbers: 130909
R01CA085566-06A1 ( U.S. NIH Grant/Contract )
NCI-2012-00551 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Rutgers, The State University of New Jersey:
Psychosocial Effects of Cancer and Treatment
Coping