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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03902379
Other study ID # Pro20160000637
Secondary ID NCI-2017-02300Pr
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 27, 2016
Est. completion date May 31, 2020

Study information

Verified date April 2021
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Carcinoma, Ovarian Epithelial
  • Carcinosarcoma
  • Endometrial Carcinoma
  • Endometrial Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • 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 Cervical Neoplasms
  • Uterine Corpus Sarcoma

Intervention

Other:
Internet-Based Intervention
Receive CCI intervention
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention 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 Changes in psychological adaptation- Beck Depression Inventory (BDI) Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63 Baseline up to 2 months
Secondary Changes in psychological adaptation-Mental Health Inventory (MHI) Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used Baseline up to 2 months
Secondary Changes in psychological coping Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests. Baseline up to 2 months
Secondary Examine acceptability of an online CCI 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
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