nctId: NCT06378749 id: 1R43CA275673 type: NIH link: https://reporter.nih.gov/quickSearch/1R43CA275673 briefTitle: Previvors Recharge: A Resilience Program for Cancer Previvors acronym: PreCharge overallStatus: RECRUITING date: 2024-04-11 date: 2024-07-31 date: 2024-07-31 date: 2024-04-22 date: 2024-04-24 name: Pro-Change Behavior Systems class: OTHER briefSummary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale. conditions: Hereditary Cancer conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PreCharge measure: Connor Davidson Resilience Scale (CDRISC) measure: Cantril/Gallup Life Evaluation Index measure: Acceptance and Action Questionnaire (AAQII) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Generalized Anxiety Disorder-2 (GAD-2) measure: Cancer Behavior Inventory (CBI-B V2.0-12) measure: Net Promoter Score (NPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pro-Change Behavior Systems status: RECRUITING city: Narragansett state: Rhode Island zip: 02882 country: United States name: Kerry E Evers, PhD role: CONTACT phone: 401-360-2985 email: kevers@prochange.com name: Madison Gilmore role: CONTACT phone: 401-360-2988 email: mgilmore@prochange.com name: Kerry E Evers, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.4501 lon: -71.4495 hasResults: False