Psychological Interventions for Gynecologic Cancer

NCT01951807 | Completed DMC

• 3 other identifiers: 130909R01CA085566-06A1NCI-2012-00551
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 9

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.

Conditions

Gynecologic Cancer

Keywords

Psychosocial Effects of Cancer and Treatment; Coping

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Coping & Communication Skills

EXPERIMENTAL

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

Supportive Counseling (SC)

EXPERIMENTAL

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

Behavioral: Psychotherapy

Usual Care (UC)

NO INTERVENTION

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).

Interventions

Psychotherapy BEHAVIORAL

Coping & Communication Skills; Supportive Counseling (SC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (9)

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

Location

Jefferson University School of Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: September 27, 2013
• Study Start: June 1, 2010
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (9)