Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378749
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-17
Brief Title:
Previvors Recharge A Resilience Program for Cancer Previvors
Sponsor:
Pro-Change Behavior Systems
Organization:
Pro-Change Behavior Systems
Study Overview
Official Title:
Previvors Recharge A Resilience Program for Cancer Previvors
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreCharge
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None