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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

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