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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kerry E Evers, Ph.D.
- 전화번호: 401-360-2985
- 이메일: kevers@prochange.com
연구 연락처 백업
- 이름: Madison Gilmore
- 전화번호: 401-360-2988
- 이메일: mgilmore@prochange.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in coping self-efficacy
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
기간: 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)
기간: 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.
|
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Change in resilience measured by the Connor-Davidson Resilience Scale-10 (CD-RISC-10)
기간: 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.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Kerry E Evers, Ph.D., ProChange Behavior Solutions
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 내분비계 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 신생물
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 유전병, 선천적
- 대사 질환
- 장 질환
- 위장관 신생물
- 소화계 신생물
- 소화기계 질환
- 위장병
- 대장 신생물
- 장 신생물
- 생식기 질환, 여성
- 내분비샘 신생물
- 결장 질환
- 난소 질환
- 부속기 질환
- 생식기 신생물, 여성
- 생식선 장애
- 피부병
- 유방 질환
- DNA 수리-결핍 장애
- 유방 신생물
- 난소 신생물
- 선천성, 유전성, 신생아 질환 및 이상
- 영양 및 대사 질환
- 피부 및 결합 조직 질환
- 결장직장 신생물, 유전성 비용종증
- 종양 증후군, 유전
- 유전성 유방암 및 난소암 증후군
기타 연구 ID 번호
기타 연구 ID 번호
- PreCharge 2025-01
- R44CA275673 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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