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Clinical Trials/NCT06378749
NCT06378749CompletedNot Applicable

Previvors Recharge: A Resilience Program for Cancer Previvors

Pro-Change Behavior Systems2 sites in 1 country138 target enrollmentStarted: April 11, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
138
Locations
2
Primary Endpoint
Connor Davidson Resilience Scale (CDRISC)

Study Overview

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 to be examined will include pre-post changes on the Connor Davidson Resilience Scale.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Identified as having Hereditary Cancer Syndrome
  • Never having been diagnosed with cancer
  • Over 18 years of age
  • Living in the United States
  • English speaking
  • Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)
  • Access to a mobile phone
  • Agree to receive text messages.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Connor Davidson Resilience Scale (CDRISC)

Time Frame: Baseline and 1 Month

This 10-item scale assesses five factors related to resilience. Each item is rated on a 5-point scale with higher scores reflecting greater resilience. Scores range from 0-40. There are well-established norms across a variety of populations and the scale has been used as an outcome measure to evaluate a variety of different intervention programs.

Secondary Outcomes

  • Acceptance and Action Questionnaire (AAQII)(Baseline and 1 Month)

Investigators

Sponsor
Pro-Change Behavior Systems
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kerry E. Evers

Co-President and CEO, Principal Investigator

Pro-Change Behavior Systems

Study Sites (2)

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