Endometrial CarcinomaNCT03902379
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Endometrial Carcinoma and Stage 0 Fallopian Tube Cancer AJCC v7, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma, Stage 0 Fallopian Tube Cancer AJCC v7, Stage I Fallopian Tube Cancer AJCC v6 and v7
- What is being tested?
- Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2016to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- English speaking
- Has internet access
- Must give informed consent within 6 months of diagnosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- 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
- Being tested
- Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Endometrial Neoplasms, Fallopian Tube Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Receive CCI intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (CCI intervention) | Experimental | Patients complete 3 modules of online CCI intervention. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
Secondary outcomes (4)
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
Measured: Baseline up to 2 months
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
Measured: Baseline up to 2 months
Changes in psychological coping
Pre-post changes in the Impact of Event Scale (IES) scales will be examined using t-tests.
Measured: Baseline up to 2 months
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start27 Jul 2016
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Why it stopped: The study was never initiated, no patients were enrolled. It has been closed with the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey
- Investigators
- Sharon Manne, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902379
- Sponsor's protocol ID
- Pro20160000637
- Other IDs
- NCI-2017-02300, Pro20160000637, 131602, P30CA072720
- Status last verified
- Apr 2021
- First submitted
- 6 Jul 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Coping and Communication Skills Intervention for Women Who Are Newly Diagnosed With Gynecological Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03902379
- Acronym / sponsor ID
- Pro20160000637
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never initiated, no patients were enrolled. It has been closed with the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (CCI intervention) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients complete 3 modules of online CCI intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionReceive CCI intervention | Other | Supportive Care (CCI intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (CCI intervention) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (CCI intervention) |
| Survey AdministrationAncillary studies | Other | Supportive Care (CCI intervention) |
Primary outcome
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.
4 secondary outcomes
Changes in psychological adaptation- Beck Depression Inventory (BDI)
Time frame: Baseline up to 2 months
Changes in psychological adaptation-Mental Health Inventory (MHI)
Time frame: Baseline up to 2 months
Changes in psychological coping
Time frame: Baseline up to 2 months
Examine acceptability of an online CCI
Time frame: Up to 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Related trials for Endometrial Carcinoma
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Manne principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Endometrial Carcinoma and Stage 0 Fallopian Tube Cancer AJCC v7, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine feasibility of an online CCI as defined by participant's evaluation of the online intervention (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.