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Trial Title:
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
NCT ID:
NCT05786456
Condition:
Malignant Female Reproductive System Neoplasm
Stage III Cervical Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Stage III Uterine Corpus Cancer AJCC v8
Stage III Vaginal Cancer AJCC v8
Stage III Vulvar Cancer AJCC v8
Stage IV Cervical Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Uterine Corpus Cancer AJCC v8
Stage IV Vaginal Cancer AJCC v8
Stage IV Vulvar Cancer AJCC v8
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Participate in group and web-based self-study sessions
Arm group label:
Supportive Care (DBD)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Informational Intervention
Description:
Receive handouts
Arm group label:
Supportive Care (DBD)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
View videos
Arm group label:
Supportive Care (DBD)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (DBD)
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Participate in check-in calls
Arm group label:
Supportive Care (DBD)
Summary:
This clinical trial studies how well an electronic (e)-health intervention (day-by-day)
woks in managing fears or worries about cancer growing, spreading, or getting worse
(progression) in patients with stage III or IV gynecologic cancer. Fear and worries about
cancer progression or recurrence (coming back) are common concerns. This may contribute
to concerns related to illness, worries, and uncertainty about the future. Day by Day is
adapted from a program called "Conquer Fear" which was shown to benefit patients with
early-stage cancer. Day-by-day intervention may help refocus patient thoughts and help
patients learn skills to manage anxiety and fears.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Start date:
July 19, 2024
Completion date:
December 20, 2024
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05786456
