Clinical trial NCT03902379: Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer
Official title: Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endometrial Carcinoma
Stage 0 Fallopian Tube Cancer AJCC v7
Stage I Fallopian Tube Cancer AJCC v6 and v7
Stage I Ovarian Cancer AJCC v6 and v7
Stage IA Fallopian Tube Cancer AJCC v6 and v7
Stage IA Ovarian Cancer AJCC v6 and v7
Stage IB Fallopian Tube Cancer AJCC v6 and v7
Stage IB Ovarian Cancer AJCC v6 and v7
Stage IC Fallopian Tube Cancer AJCC v6 and v7
Stage IC Ovarian Cancer AJCC v6 and v7
Stage II Cervical Cancer AJCC v7
Stage II Fallopian Tube Cancer AJCC v6 and v7
Stage II Ovarian Cancer AJCC v6 and v7
Stage II Uterine Corpus Cancer AJCC v7
Stage IIA Cervical Cancer AJCC v7
Stage IIA Fallopian Tube Cancer AJCC v6 and v7
Stage IIA Ovarian Cancer AJCC V6 and v7
Stage IIA1 Cervical Cancer AJCC v7
Stage IIA2 Cervical Cancer AJCC v7
Stage IIB Cervical Cancer AJCC v6 and v7
Stage IIB Fallopian Tube Cancer AJCC v6 and v7
Stage IIB Ovarian Cancer AJCC v6 and v7
Stage IIC Fallopian Tube Cancer AJCC v6 and v7
Stage IIC Ovarian Cancer AJCC v6 and v7
Stage III Cervical Cancer AJCC v6 and v7
Stage III Fallopian Tube Cancer AJCC v7
Stage III Ovarian Cancer AJCC v6 and v7
Stage III Primary Peritoneal Cancer AJCC v7
Stage III Uterine Corpus Cancer AJCC v7
Stage IIIA Cervical Cancer AJCC v6 and v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIA Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIA Uterine Corpus Cancer AJCC v7
Stage IIIB Cervical Cancer AJCC v6 and v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IIIB Uterine Corpus Cancer AJCC v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Stage IIIC Uterine Corpus Cancer AJCC v7
Stage IIIC1 Uterine Corpus Cancer AJCC v7
Stage IIIC2 Uterine Corpus Cancer AJCC v7
Stage IV Cervical Cancer AJCC v6 and v7
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Stage IVA Cervical Cancer AJCC v6 and v7
Stage IVA Uterine Corpus Cancer AJCC v7
Stage IVB Cervical Cancer AJCC v6 and v7
Stage IVB Uterine Corpus Cancer AJCC v7
Uterine Carcinosarcoma
Uterine Corpus Sarcoma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention
timeFrame: Up to 2 months
Secondary outcomes:
measure: Changes in psychological adaptation- Beck Depression Inventory (BDI)
timeFrame: Baseline up to 2 months
measure: Changes in psychological adaptation-Mental Health Inventory (MHI)
timeFrame: Baseline up to 2 months
measure: Changes in psychological coping
timeFrame: Baseline up to 2 months
measure: Examine acceptability of an online CCI
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne
role: PRINCIPAL_INVESTIGATOR
References: