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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kerry E Evers, Ph.D.
- Telefonnummer: 401-360-2985
- E-Mail: kevers@prochange.com
Studieren Sie die Kontaktsicherung
- Name: Madison Gilmore
- Telefonnummer: 401-360-2988
- E-Mail: mgilmore@prochange.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
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. |
|
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in coping self-efficacy
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kerry E Evers, Ph.D., ProChange Behavior Solutions
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Erkrankungen des endokrinen Systems
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Genetische Krankheiten, angeboren
- Stoffwechselerkrankungen
- Darmerkrankungen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kolorektale Neubildungen
- Darmtumoren
- Genitalerkrankungen, weiblich
- Neoplasmen der endokrinen Drüse
- Darmerkrankungen
- Eierstockerkrankungen
- Adnexerkrankungen
- Genitale Neubildungen, weiblich
- Gonadenstörungen
- Hautkrankheiten
- Brusterkrankungen
- DNA-Reparatur-Mangel-Störungen
- Neoplasien der Brust
- Eierstocktumoren
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Ernährungs- und Stoffwechselerkrankungen
- Haut- und Bindegewebserkrankungen
- Kolorektale Neubildungen, erbliche Nichtpolyposis
- Neoplastische Syndrome, erblich
- Erbliches Brust- und Eierstockkrebssyndrom
Andere Studien-ID-Nummern
- PreCharge 2025-01
- R44CA275673 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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