PreCharge: An Innovative Digital Program to Increase Coping, Resilience, and Health Care Engagement Among Cancer Previvors ((PreCharge))

November 8, 2026 updated by: Pro-Change Behavior Systems

The goal of this clinical trial is to learn if PreCharge helps adults cope with an inherited risk of cancer. PreCharge is a personalized online support program for people with a hereditary cancer syndrome. The study is for adults who have not had cancer, with an exception for non-melanoma skin cancer.

The main question the study aims to answer is:

• Does PreCharge help participants feel more confident in their ability to cope with their inherited cancer risk? Researchers will compare participants who use PreCharge with participants who do not use the program during the study. Researchers will also look at participants' resilience, anxiety, depressive symptoms, cancer worry, and overall well-being.

Participants will be assigned by chance to one of two groups. Participants in both groups will answer online surveys at the start of the study and about 3 and 6 months later.

  • Participants in the PreCharge group will have access to the program for 6 months. They will receive text messages and can use the online program's information and activities.
  • Participants in the comparison group will have access to a webpage with mental health and hereditary cancer resources.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
574

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Reside in the United States.
  • Self-report having a hereditary cancer syndrome.
  • Able to read and communicate in English.
  • Willing to receive text messages during the 6-month study period.
  • Score of 100 or less on the 12-item Cancer Behavior Inventory-Brief Version (CBI-B) at screening.

Exclusion Criteria:

  • Self-reported personal history of cancer, except non-melanoma skin cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PreCharge

Participants receive access to PreCharge, a personalized digital psychosocial support program, for six months. The program includes a web-based portal and text messages that provide tailored information, activities, and support. Participants complete study assessments at baseline and at three and six months.
Behavioral: PreCharge digital psychosocial support program

PreCharge is a six-month, personalized digital psychosocial support program for adults with hereditary cancer syndromes who have not been diagnosed with cancer. The program is delivered through a web-based portal and tailored text messages. It provides tailored information, activities, and tools to support coping with hereditary cancer risk. Participants can access the portal throughout the intervention period, and their responses to check-ins help personalize program recommendations and messages over time.
No Intervention: Assessment-Only Control

Participants complete study assessments at baseline and at three and six months. They do not receive access to the PreCharge program during the study. They have access to a static webpage with mental health and hereditary cancer resources.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in coping self-efficacy
Time Frame: Screening (baseline), 3 months, and 6 months

Coping self-efficacy will be assessed using the 12-item Cancer Behavior Inventory-Brief Version (CBI-B), adapted for individuals with hereditary cancer risk who have not been diagnosed with cancer (previvors). Each item is rated from 1 (not at all confident) to 9 (totally confident). Item scores are summed to produce a total score ranging from 12 to 108, with higher scores indicating greater coping self-efficacy. Changes in total scores over time will be compared between the PreCharge and assessment-only control groups. The screening score serves as the baseline measure.
Screening (baseline), 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
Time Frame: Baseline, 3-month follow-up, and 6-month follow-up.

Depressive symptoms will be assessed using the two-item Patient Health Questionnaire-2 (PHQ-2). Participants report how often they experienced depressed mood and little interest or pleasure in activities during the previous two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 6, with higher scores indicating more frequent depressive symptoms. Changes over time will be compared between study groups.
Baseline, 3-month follow-up, and 6-month follow-up.
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-2 (GAD-2)
Time Frame: Baseline, 3-month follow-up, and 6-month follow-up.

Anxiety symptoms will be assessed using the two-item Generalized Anxiety Disorder-2 (GAD-2). Participants report how often they were bothered by feeling nervous, anxious, or on edge and being unable to stop or control worrying during the previous two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 6, with higher scores indicating more frequent anxiety symptoms. Changes over time will be compared between study groups.
Baseline, 3-month follow-up, and 6-month follow-up.
Change in resilience measured by the Connor-Davidson Resilience Scale-10 (CD-RISC-10)
Time Frame: Baseline, 3-month follow-up, and 6-month follow-up.

Resilience will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Each item is scored from 0 (not at all true) to 4 (true nearly all the time). Item scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater resilience. Changes over time will be compared between study groups.
Baseline, 3-month follow-up, and 6-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pro-Change Behavior Systems

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerry E Evers, Ph.D., ProChange Behavior Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PreCharge 2025-01
  • R44CA275673 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings