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
Official title: Novel e-Health Intervention for Fear of Progression in Women With Gynecologic Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-27
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Primary outcomes:
measure: Feasibility of recruitment (enrollment rate)
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Fear of progression (FOP)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Anne Reb
role: PRINCIPAL_INVESTIGATOR
References: