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

April 16, 2021 updated by: Sharon Manne, PhD, Rutgers, The State University of New Jersey

Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (CCI intervention)
Patients complete 3 modules of online CCI intervention.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
Other: Internet-Based Intervention
Receive CCI intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention
Time Frame: 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.
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in psychological adaptation- Beck Depression Inventory (BDI)
Time Frame: Baseline up to 2 months
Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63
Baseline up to 2 months
Changes in psychological adaptation-Mental Health Inventory (MHI)
Time Frame: Baseline up to 2 months
Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used
Baseline up to 2 months
Changes in psychological coping
Time Frame: Baseline up to 2 months
Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.
Baseline up to 2 months
Examine acceptability of an online CCI
Time Frame: 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.
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2016

Primary Completion (Anticipated)

May 31, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro20160000637
  • P30CA072720 (U.S. NIH Grant/Contract)
  • NCI-2017-02300 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 131602 (Rutgers Cancer Institute of New Jersey)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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