Psychological Interventions for Gynecologic Cancer

N/ACompletedNCT01951807

Rutgers, The State University of New Jersey375 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

375

Conditions

Gynecologic Cancer

Interventions

PsychotherapyBEHAVIORAL

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 7 years

Data from ClinicalTrials.gov

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