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e-Health Intervention for Cancer of the Female Reproductive System
N/A
Recruiting
Led By Anne Reb
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: >= 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This trial studies an e-health intervention to help manage fears and worries about cancer progression in gynecologic cancer patients. Day by Day may help refocus thoughts and learn skills to manage anxiety.
Who is the study for?
This trial is for English-speaking women over 18 with stage III or IV gynecologic cancer (ovarian, endometrial, cervical, vulvar/vaginal), at least 3 months post-diagnosis. They must have significant fear of their cancer progressing as measured by a specific questionnaire. Those in hospice care, with severe depression, or unable to follow the study plan are excluded.Check my eligibility
What is being tested?
The trial tests an e-health intervention called 'Day-by-Day' designed to manage fears about cancer progression in patients with advanced gynecologic cancers. It's based on the 'Conquer Fear' program and includes discussions, informational media interventions, questionnaires and telephone support to help reduce anxiety.See study design
What are the potential side effects?
Since this is a psychological support intervention involving discussion and information sharing rather than medication or medical procedures, traditional physical side effects are not expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of recruitment (enrollment rate)
Secondary outcome measures
Fear of progression (FOP)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (DBD)Experimental Treatment5 Interventions
Patients receive DBD intervention consisting of group and web-based self-study sessions and check-in calls on study. Patients also watch videos and receive handouts to reinforce the group sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2021
N/A
~130
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,541 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,675 Total Patients Enrolled
Anne RebPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer is either improving or getting worse.I am a woman diagnosed with advanced GYN cancer more than 3 months ago.Your score on the Fear of Progression Short-Form is 34 or higher, which means you have high levels of fear and worry about your condition.You are currently receiving care in a hospice.You have been diagnosed with severe depression using the Patient Health Questionnaire (PHQ-9).
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (DBD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still being recruited for this experiment?
"According to clinicaltrials.gov records, this medical trial is not soliciting participants at the moment; it was first released on June 15th 2023 and its details were most recently revised on March 24th of 2023. Though the current study does not accept fresh applications, 901 other trials are presently seeking volunteers."
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