Previvors Recharge: A Resilience Program for Cancer Previvors

NCT ID: NCT06378749

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2024-09-27

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.

Conditions

Hereditary Cancer; Mental Health Issue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PreCharge Intervention Pilot

After completing the baseline assessment, all pilot participants will have access to the PreCharge pilot program for 30 days. At the end of the 30 day pilot, they will be directed to the follow-up assessment.

Group Type: EXPERIMENTAL

PreCharge

Intervention Type: BEHAVIORAL

PreCharge is an intervention for Hereditary Cancer Syndrome Previvors that administers brief assessments and uses multivariate algorithms and tailoring technology to provide timely, individualized, bi-directional text messages to improve resilience and coping. The program 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. It will also proactively provide access to online tools prior to medical appointments to address scanxiety (e.g., management of emotion tips; mindfulness meditation; communication scripts; breathing exercises). At any time, users will be able to text a trigger word to indicate that they need extra support and will receive just-in-time assistance via text message.

Interventions

PreCharge

PreCharge is an intervention for Hereditary Cancer Syndrome Previvors that administers brief assessments and uses multivariate algorithms and tailoring technology to provide timely, individualized, bi-directional text messages to improve resilience and coping. The program 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. It will also proactively provide access to online tools prior to medical appointments to address scanxiety (e.g., management of emotion tips; mindfulness meditation; communication scripts; breathing exercises). At any time, users will be able to text a trigger word to indicate that they need extra support and will receive just-in-time assistance via text message.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Identified as having Hereditary Cancer Syndrome

2. Never having been diagnosed with cancer

3. Over 18 years of age

4. Living in the United States

5. English speaking

6. Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)

7. Access to a mobile phone

8. Agree to receive text messages.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pro-Change Behavior Systems

OTHER

Sponsor Role: lead

Responsible Party

Kerry E. Evers

Co-President and CEO, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pro-Change Behavior Systems

Narragansett, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R43CA275673

Identifier Type: NIH

Identifier Source: org_study_id

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