This clinical trial studies how well an electronic (e)-health intervention (day-by-day) works in managing fears or worries about cancer growing, spreading, or getting worse (progression) in patients with stage III or IV gynecologic or breast 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05786456.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Will adapt the intervention into a hybrid format including two group and four 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) or breast 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): Participants provide feedback and complete a survey for video and website development on study.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorAnne Reb
