- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786456
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Novel e-Health Intervention for Fear of Progression in Women With Gynecologic Cancer: A Pilot Study
Study Overview
Status
Conditions
- Stage III Uterine Corpus Cancer AJCC v8
- Stage IV Uterine Corpus Cancer AJCC v8
- Malignant Female Reproductive System Neoplasm
- Stage III Cervical Cancer AJCC v8
- Stage IV Cervical Cancer AJCC v8
- Stage IV Vulvar Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Vaginal Cancer AJCC v8
- Stage III Vulvar Cancer AJCC v8
- Stage III Vaginal Cancer AJCC v8
Detailed Description
PRIMARY OBJECTIVES:
I. Will adapt the intervention into a hybrid format including two group and three web based self-study sessions. (Phase 1) II. To determine the feasibility and acceptability of a new hybrid e-health intervention to manage fear of progression (FOP) in patients with stage III or IV gynecologic (GYN) cancer. (Phase 2)
SECONDARY OBJECTIVE:
I. To explore the preliminary efficacy of day-by-day (DBD) on reducing FOP (primary outcome) and improving secondary outcomes of distress, anxiety, depression, metacognitions, and mindfulness. (Exploratory)
OUTLINE:
PHASE I (DEVELOPMENT): Patients complete surveys and participate in focus groups.
PHASE II (DBD): 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Medical Center
-
Contact:
- Anne Reb
- Phone Number: 626-218-2987
-
Principal Investigator:
- Anne Reb
-
Contact:
- Email: areb@coh.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women with stage III or IV GYN cancer (ovarian, endometrial, cervical, vulvar/vaginal);at least 3 months from initial diagnosis
- Age: >= 18 years
- Score >= 34 on the Fear of Progression Short-Form, indicating dysfunctional levels
- Ability to read and understand English
- Patients in remission or with progressive disease are eligible
Exclusion Criteria:
- Enrolled in hospice
- Severe depression as assessed by Patient Health Questionnaire (PHQ-9)
- Non-English speaking
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Care (DBD)
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.
|
Ancillary studies
Receive handouts
Participate in group and web-based self-study sessions
Other Names:
View videos
Participate in check-in calls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment (enrollment rate)
Time Frame: Up to 6 weeks
|
Defined by attendance, attrition, and skills practice adherence.
Website acceptability is based on the System Usability Scale, log-in activity, activity completion rate, and most frequently visited site content.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of progression (FOP)
Time Frame: Up to 12 weeks
|
FOP will be assessed using FOP Questionnaire-Short Form (SF) at baseline (T1), weeks (T2), and 12 weeks (T3).
FOP-Q-SF consists of 12 items scored on a 5-point Likert scale (1=never to 5=very often); scores range from 12-60 with higher levels indicating greater FOP.
Researchers have used a cut-off of 34 and above to indicate dysfunctional FOP.
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Reb, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Vaginal Diseases
- Vulvar Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
- Genital Neoplasms, Female
- Vaginal Neoplasms
Other Study ID Numbers
- 22683 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2023-00309 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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