Previvors Recharge: A Resilience Program for Cancer Previvors

NCT06378749 | Completed Results

• 1 other identifier: 1R43CA275673
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Keywords

Resilience; Coping; Previvor; well-being

Outcome Measures

Primary Outcomes (1)

• Connor Davidson Resilience Scale (CDRISC)

  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.

  Baseline and 1 Month

Secondary Outcomes (1)

• Acceptance and Action Questionnaire (AAQII)

  Baseline and 1 Month

Other Outcomes (3)

• Patient Health Questionnaire-2 (PHQ-2)

  Baseline and 1 Month

• Generalized Anxiety Disorder-2 (GAD-2)

  Baseline and 1 Month

• Cancer Behavior Inventory (CBI-B V2.0-12)

  Baseline and 1 Month

Study Arms (1)

PreCharge Intervention Pilot

EXPERIMENTAL

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.

Behavioral: PreCharge

Interventions

PreCharge 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.

PreCharge Intervention Pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead

Study Sites (1)

Pro-Change Behavior Systems

Narragansett, Rhode Island, 02882, United States

Location

Results Point of Contact

• Title: Kerry E. Evers
• Organization: Pro-Change Behavior Systems, Inc.

kevers@prochange.com

4013602985

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-President and CEO, Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: April 11, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

US (1)