An interventional study of PreCharge digital psychosocial support program in Well-being, Hereditary Cancer Syndromes and Genetic Predisposition to Cancer, sponsored by Pro-Change Behavior Systems. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Pro-Change Behavior Systems · Not applicable, Interventional, and Supportive care
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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:
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.
46 studies on the registry are indexed under Neoplastic Syndromes, Hereditary; 25 are open to participants now.
This study's planned enrollment of 574 is above the median of 421 across 22 interventional studies indexed under Neoplastic Syndromes, Hereditary.
Browse Neoplastic Syndromes, Hereditary studies →Pro-Change Behavior Systems is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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.
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.
Change in coping self-efficacy
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.
Time frame: Screening (baseline), 3 months, and 6 months
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
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.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-2 (GAD-2)
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.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
Change in resilience measured by the Connor-Davidson Resilience Scale-10 (CD-RISC-10)
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.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up.
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Neoplastic Syndromes, Hereditary →
Pro-Change Behavior Systems