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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03902379
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location
1
Arm
46.1
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Internet-Based Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

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

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
Actual Study Start Date :
Jul 27, 2016
Anticipated Primary Completion Date :
May 31, 2020
Anticipated Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (CCI intervention)

Patients complete 3 modules of online CCI intervention.

Other: Internet-Based Intervention
Receive 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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sharon Manne, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sharon Manne, PhD, Professor of Medicine, Rutgers Cancer Institute of New Jersey
    ClinicalTrials.gov Identifier:
    NCT03902379
    Other Study ID Numbers:
    • Pro20160000637
    • NCI-2017-02300
    • Pro20160000637
    • 131602
    • P30CA072720
    First Posted:
    Apr 4, 2019
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Uterine Cervical Neoplasms
    Fallopian Tube Neoplasms
    Peritoneal Neoplasms
    Endometrial Neoplasms
    Carcinosarcoma

    Study Results

    No Results Posted as of Apr 19, 2021