Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer

Rutgers The State University of New Jersey

Status: Withdrawn

Conditions: Stage II Ovarian Cancer AJCC v6 and v7; Stage IIB Cervical Cancer AJCC v6 and v7; Stage IC Fallopian Tube Cancer AJCC v6 and v7; Stage IIIA Uterine Corpus Cancer AJCC v7; Endometrial Carcinoma; Stage IIIB Uterine Corpus Cancer AJCC v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IIB Ovarian Cancer AJCC v6 and v7; Stage III Ovarian Cancer AJCC v6 and v7; Stage IC Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7; Stage IIA Fallopian Tube Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage 0 Fallopian Tube Cancer AJCC v7; Stage III Fallopian Tube Cancer AJCC v7; Stage IB Fallopian Tube Cancer AJCC v6 and v7; Stage II Fallopian Tube Cancer AJCC v6 and v7; Stage III Cervical Cancer AJCC v6 and v7; Stage IIIC Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7; Stage IA Ovarian Cancer AJCC v6 and v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIC Ovarian Cancer AJCC v6 and v7; Uterine Corpus Sarcoma; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IVA Uterine Corpus Cancer AJCC v7; Stage IIB Fallopian Tube Cancer AJCC v6 and v7; Stage III Uterine Corpus Cancer AJCC v7; Stage IIIC1 Uterine Corpus Cancer AJCC v7; Stage IVA Cervical Cancer AJCC v6 and v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IVB Uterine Corpus Cancer AJCC v7; Stage I Fallopian Tube Cancer AJCC v6 and v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IV Cervical Cancer AJCC v6 and v7; Stage IIA Cervical Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIC Fallopian Tube Cancer AJCC v6 and v7; Stage IIA2 Cervical Cancer AJCC v7; Uterine Carcinosarcoma; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IVB Cervical Cancer AJCC v6 and v7; Stage IIA1 Cervical Cancer AJCC v7; Stage I Ovarian Cancer AJCC v6 and v7; Stage IV Uterine Corpus Cancer AJCC v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIA Ovarian Cancer AJCC V6 and v7; Stage II Cervical Cancer AJCC v7; Stage IB Ovarian Cancer AJCC v6 and v7; Stage IIIB Cervical Cancer AJCC v6 and v7; Stage IA Fallopian Tube Cancer AJCC v6 and v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Cervical Cancer AJCC v6 and v7; Stage IIIC2 Uterine Corpus Cancer AJCC v7

Treatments: Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03902379

P30CA072720 (U.S. NIH Grant/Contract)

NCI-2017-02300 (Registry Identifier)

Pro20160000637

131602

Details and patient eligibility

About

This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.

Full description

PRIMARY OBJECTIVES:

I. To examine the feasibility and acceptability of an online coping and communication skills intervention (CCI).

II. To collect pilot data on the impact of online CCI on global and cancer-specific distress.

OUTLINE:

Patients complete 3 modules of online CCI intervention.

After completion of study, patients are followed up at 2 months.

Sex: Female

Ages: 18+ years old

Volunteers: No 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 within the past 6 months
• Newly diagnosed with any stage 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) (80) score of 0 or 1
• English speaking
• Has internet access
• Must give informed consent within 6 months of diagnosis

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive Care (CCI intervention)

Experimental group

Description:

Patients complete 3 modules of online CCI intervention.

Treatment:

Other: Survey Administration

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment