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

8. november 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

574

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

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.

Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in coping self-efficacy
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Kerry E Evers, Ph.D., ProChange Behavior Solutions

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

8. november 2026

Først innsendt som oppfylte QC-kriteriene

8. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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