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

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ClinicalTrials.gov Identifier: NCT03902379
Recruitment Status : Withdrawn (The study was never initiated, no patients were enrolled. It has been closed with the IRB.)
First Posted : April 4, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sharon Manne, PhD, Rutgers Cancer Institute 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.

Condition or disease Intervention/treatment Phase
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 Other: Internet-Based Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : July 27, 2016
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020


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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902379


Locations
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United States, New Jersey
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
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Principal Investigator: Sharon Manne Rutgers Cancer Institute of New Jersey

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Responsible Party: Sharon Manne, PhD, Professor of Medicine, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT03902379     History of Changes
Other Study ID Numbers: 131602
NCI-2017-02300 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20160000637
131602 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Carcinosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases