NCT03902379

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

July 6, 2018

Last Update Submit

April 16, 2021

Conditions

Endometrial CarcinomaStage 0 Fallopian Tube Cancer AJCC v7Stage I Fallopian Tube Cancer AJCC v6 and v7Stage I Ovarian Cancer AJCC v6 and v7Stage IA Fallopian Tube Cancer AJCC v6 and v7Stage IA Ovarian Cancer AJCC v6 and v7Stage IB Fallopian Tube Cancer AJCC v6 and v7Stage IB Ovarian Cancer AJCC v6 and v7Stage IC Fallopian Tube Cancer AJCC v6 and v7Stage IC Ovarian Cancer AJCC v6 and v7Stage II Cervical Cancer AJCC v7Stage II Fallopian Tube Cancer AJCC v6 and v7Stage II Ovarian Cancer AJCC v6 and v7Stage II Uterine Corpus Cancer AJCC v7Stage IIA Cervical Cancer AJCC v7Stage IIA Fallopian Tube Cancer AJCC v6 and v7Stage IIA Ovarian Cancer AJCC V6 and v7Stage IIA1 Cervical Cancer AJCC v7Stage IIA2 Cervical Cancer AJCC v7Stage IIB Cervical Cancer AJCC v6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIB Ovarian Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage IIC Ovarian Cancer AJCC v6 and v7Stage III Cervical Cancer AJCC v6 and v7Stage III Fallopian Tube Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IIIA Cervical Cancer AJCC v6 and v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIA Uterine Corpus Cancer AJCC v7Stage IIIB Cervical Cancer AJCC v6 and v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIB Uterine Corpus Cancer AJCC v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IIIC Uterine Corpus Cancer AJCC v7Stage IIIC1 Uterine Corpus Cancer AJCC v7Stage IIIC2 Uterine Corpus Cancer AJCC v7Stage IV Cervical Cancer AJCC v6 and v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Stage IVA Cervical Cancer AJCC v6 and v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Cervical Cancer AJCC v6 and v7Stage IVB Uterine Corpus Cancer AJCC v7Uterine CarcinosarcomaUterine Corpus Sarcoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in psychological adaptation- Beck Depression Inventory (BDI)

    Baseline up to 2 months

  • Changes in psychological adaptation-Mental Health Inventory (MHI)

    Baseline up to 2 months

  • Changes in psychological coping

    Baseline up to 2 months

  • Examine acceptability of an online CCI

    Up to 2 months

Study Arms (1)

Supportive Care (CCI intervention)

EXPERIMENTAL

Patients complete 3 modules of online CCI intervention.

Other: Internet-Based InterventionOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Survey Administration

Interventions

Internet-Based InterventionOTHER

Receive CCI intervention

Supportive Care (CCI intervention)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (CCI intervention)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care (CCI intervention)
Survey AdministrationOTHER

Ancillary studies

Supportive Care (CCI intervention)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Endometrial NeoplasmsFallopian Tube NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesUterine Cervical Diseases

Study Officials

  • Sharon Manne

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 6, 2018

First Posted

April 4, 2019

Study Start

July 27, 2016

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations

US(1)