Psychological Interventions for Gynecologic Cancer

Rutgers The State University of New Jersey

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Behavioral: Psychotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01951807

130909

NCI-2012-00551 (Other Identifier)

R01CA085566-06A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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375 participants in 3 patient groups

Coping & Communication Skills

Experimental group

Description:

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.

Treatment:

Behavioral: Psychotherapy

Supportive Counseling (SC)

Experimental group

Description:

The SC intervention incorporates a supportive, non-directive counseling approach in seven weekly 60 minute sessions

Treatment:

Behavioral: Psychotherapy

Usual Care (UC)

No Intervention group

Description:

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).