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

Not Applicable

Withdrawn

• Conditions: Stage II Ovarian Cancer AJCC v6 and v7; Endometrial Carcinoma; Stage 0 Fallopian Tube Cancer AJCC v7; Stage IA Fallopian Tube Cancer AJCC v6 and v7; Stage II Cervical Cancer AJCC v7; Stage IIA Cervical Cancer AJCC v7; Stage III Cervical Cancer AJCC v6 and v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Uterine Corpus Cancer AJCC v7; Stage IIIB Cervical Cancer AJCC v6 and v7
• Interventions: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT03902379
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2016-07-27
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-04
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (CCI intervention)	Internet-Based Intervention	Patients complete 3 modules of online CCI intervention.
Supportive Care (CCI intervention)	Quality-of-Life Assessment	Patients complete 3 modules of online CCI intervention.
Supportive Care (CCI intervention)	Questionnaire Administration	Patients complete 3 modules of online CCI intervention.
Supportive Care (CCI intervention)	Survey Administration	Patients complete 3 modules of online CCI intervention.

Primary Outcome Measures

Name	Time	Method
Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention	Up to 2 months	Will define feasibility/acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program.

Secondary Outcome Measures

Name	Time	Method
Changes in psychological adaptation- Beck Depression Inventory (BDI)	Baseline up to 2 months	Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63
Examine acceptability of an online CCI	Up to 2 months	Will define acceptability as participant's evaluation of the online intervention using both qualitative and quantitative methods. Will summarize participant?s feedback by their overall impressions, the ease of use, how much the web intervention kept their attention, how much they liked the program, feedback about how the program looked, suggestions on how to improve the look, their satisfaction with the program and why, how useful they found the program and why, how easy the information was to understand and why, to what degree they think it would make them more confident in coping with cancer, what the most and least helpful components of the program were, what aspects if any were confusing, evaluation of places where navigation were unclear, and anything they would like to add to the program.
Changes in psychological adaptation-Mental Health Inventory (MHI)	Baseline up to 2 months	Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used
Changes in psychological coping	Baseline up to 2 months	Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States