- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01114802
E-health Intervention for Cancer Survivors (Onward)
Project Onward: an Innovative E-health Intervention for Cancer Survivors
연구 개요
상세 설명
Nearly 65% of those with cancer diagnoses will survive for at least 5 years, with approximately 10.5 million cancer survivors in the United States. The time of transition for cancer patients, from active treatment to survivorship, has been identified as a time of high risk for depression and anxiety. Cancer survivors experience higher rates of anxiety and depression than those without a cancer history. Research has identified fear of recurrence, perceived loss of support, and social pressure to resume a "normal" life, among other phenomena, as sources for this emotional distress. However, only about 20% of all patients referred for psychotherapy ever enter treatment and of those who initiate treatment, nearly half drop out before completion. This suggests that there are significant barriers to receiving care. These barriers may be even higher for cancer survivors struggling with issues related to re-entry, such as returning to work, resuming household responsibilities and managing residual symptoms such as fatigue or pain.
The internet promises to provide inexpensive access to treatment at any time of the day or night. Unfortunately, the potential for internet delivered services has not been realized. Studies examining treatments that simply provide access to an internet site commonly result in very high dropout after the first site visit, and typically little or no improvement target symptoms. A variety of methods to improve responses to internet interventions have been examined. In general, e-mail support improves adherence and telephone support can improve adherence even more. Another type of support that has only begun to be investigated is the use of social networks to help maintain adherence.
This intervention will combine a variety of outreach methods, including telephone, email and an online social network, to increase adherence and promote the use of the website and the skills it teaches.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Any cancer diagnosis
- Has completed treatment for cancer and is currently in full remission.
- ECOG performance Status of < 3.
- No history of hospitalization for psychiatric reasons with in the past 5 years.
- Has a telephone, e-mail account, computer, and broadband access to the Internet.
- Has familiarity with using the Internet that allows for adequate navigation of website.
- Is able to speak and read English.
- Is at least 19 years of age.
- Is able to give informed consent.
Exclusion Criteria:
- Has hearing or voice impairment that would prevent participation in assessments or coach treatment arm
- Has visual impairment that would prevent use of the website and completion of assessment materials.
- Diagnosis of basal or squamous cell skin cancers
3) Has physical impairments that would limit use of the computer. 4) Meets criteria for dementia by scoring < 25 on the Telephone Interview for Cognitive Status (TICS).
5) Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of an internet intervention may be either inappropriate or dangerous, or has been hospitalized for psychiatric reasons within the past 5 years. Patients with substance abuse diagnoses who have been abstinent for 3 months will be admitted if otherwise eligible.
6) Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study.
7) Is planning to be out of town or unavailable for treatment for 2 weeks or more during the scheduled treatment time.
8) Exhibits severe suicidality, including ideation, plan, and intent. 9) Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Project Onward website + social network
This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.
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The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.
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활성 비교기: Project Onward website
This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy.
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Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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병원 불안 및 우울 척도(HADS)로 측정한 우울증
기간: 기준선, 4주, 8주 및 12주에 측정
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기준선, 4주, 8주 및 12주에 측정
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2차 결과 측정
결과 측정 |
기간 |
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웹사이트 활용도(예: 로그인 수, 평균 방문 시간, 사이트에 머문 총 시간, 완료한 운동 수)
기간: 기준선에서 12주까지
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기준선에서 12주까지
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공동 작업자 및 조사자
수사관
- 수석 연구원: David C. Mohr, Ph.D., Northwestern University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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