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

NCT ID: NCT03902379

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (CCI intervention)

Patients complete 3 modules of online CCI intervention.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Receive CCI intervention

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Internet-Based Intervention

Receive CCI intervention

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sharon Manne, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Manne

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-02300

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro20160000637

Identifier Type: -

Identifier Source: secondary_id

131602

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro20160000637

Identifier Type: -

Identifier Source: org_study_id

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