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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
No Placebo-Only Group
Summary
This trial studies how well the 'Day by Day' online program helps patients with advanced gynecologic cancer manage their fears about cancer progression. The program includes group sessions, self-study activities, and periodic updates to teach skills for reducing anxiety and worries.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of recruitment (enrollment rate)
Secondary study objectives
Fear of progression (FOP)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~180
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,301 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,878 Previous Clinical Trials
41,012,974 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.
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