- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07936682
PreCharge: An Innovative Digital Program to Increase Coping, Resilience, and Health Care Engagement Among Cancer Previvors ((PreCharge))
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
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kerry E Evers, Ph.D.
- Telefonnummer: 401-360-2985
- E-post: kevers@prochange.com
Studer Kontakt Backup
- Navn: Madison Gilmore
- Telefonnummer: 401-360-2988
- E-post: mgilmore@prochange.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kerry E Evers, Ph.D., ProChange Behavior Solutions
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Genetiske sykdommer, medfødte
- Metabolske sykdommer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Kjønnssykdommer, kvinner
- Neoplasmer i endokrine kjertel
- Kolonsykdommer
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Genitale neoplasmer, kvinnelige
- Gonadal lidelser
- Hudsykdommer
- Bryst sykdommer
- DNA-reparasjon-mangellidelser
- Brystneoplasmer
- Neoplasmer i eggstokkene
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Ernæringsmessige og metabolske sykdommer
- Hud- og bindevevssykdommer
- Kolorektale neoplasmer, arvelig ikke-polypose
- Neoplastiske syndromer, arvelig
- Arvelig bryst- og eggstokkreftsyndrom
Andre studie-ID-numre
- PreCharge 2025-01
- R44CA275673 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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