Psychological Interventions for Gynecologic Cancer

Gynecologic Cancer Clinical Trial

Official title:

Psychological Interventions for Gynecologic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951807
• Other study ID #: 130909
• Secondary ID: R01CA085566-06A1
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: November 15, 2017
• Start date: June 2010
• Est. completion date: July 19, 2017

Study information

• Verified date: November 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: July 19, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• Psychotherapy

Locations

Country	Name	City	State
United States	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	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Jefferson University School of Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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