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

City of Hope

Status: Active, not recruiting

Conditions: Stage III Ovarian Cancer AJCC v8; Malignant Female Reproductive System Neoplasm; Stage IV Vulvar Cancer AJCC v8; Stage III Uterine Corpus Cancer AJCC v8; Stage III Cervical Cancer AJCC v8; Stage III Vulvar Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Cervical Cancer AJCC v8; Stage IV Vaginal Cancer AJCC v8; Stage III Vaginal Cancer AJCC v8

Treatments: Behavioral: Telephone-Based Intervention; Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Procedure: Discussion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05786456

NCI-2023-00309 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

22683 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Supportive Care (DBD)

Experimental group

Description:

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:

Procedure: Discussion

Other: Questionnaire Administration

Other: Media Intervention

Other: Informational Intervention

Behavioral: Telephone-Based Intervention