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

Primary Purpose

Endometrial Carcinoma, Stage 0 Fallopian Tube Cancer AJCC v7, Stage I Fallopian Tube Cancer AJCC v6 and v7

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Quality-of-Life Assessment
Questionnaire Administration
Survey Administration
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometrial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (CCI intervention)

Arm Description

Patients complete 3 modules of online CCI intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Changes in psychological coping
Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.
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.

Full Information

First Posted
July 6, 2018
Last Updated
April 16, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03902379
Brief Title
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer
Official Title
Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never initiated, no patients were enrolled. It has been closed with the IRB.
Study Start Date
July 27, 2016 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (CCI intervention)
Arm Type
Experimental
Arm Description
Patients complete 3 modules of online CCI intervention.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive CCI intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Changes in psychological adaptation- Beck Depression Inventory (BDI)
Description
Pre-post changes in the(BDI) scales will be examined. BDI has 21 items and scores range 0-63
Time Frame
Baseline up to 2 months
Title
Changes in psychological adaptation-Mental Health Inventory (MHI)
Description
Pre-post changes in the (MHI) scales will be examined t-tests. 38-item MHI measure used
Time Frame
Baseline up to 2 months
Title
Changes in psychological coping
Description
Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.
Time Frame
Baseline up to 2 months
Title
Examine acceptability of an online CCI
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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