Teens Taking Charge: Managing Cancer Online
2019년 10월 7일 업데이트: Jennifer Stinson, The Hospital for Sick Children
Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer
Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer.
While two interactive coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not focus on helping youth gain skills for transition and independence, and (3) do not provide opportunities for meaningful social support.
In summary, there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education, self-management skills, and opportunities for social support, and that is cost-effective.
연구 개요
상태
완전한
정황
상세 설명
Overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Cancer Online" Internet intervention that will help AWC to better cope with their disease, improve their HRQL, and enhance readiness to transition to adult health care using a sequential phased approach.
The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer.
The second phase consisted of website development and usability testing to ensure the website is easy to use and understand, and is efficient and satisfying to complete.
Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3).
This will inform the design and methods of the main trial, and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT (Phase 4).
The focus of this study is Phase 3. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group.
연구 유형
중재적
등록 (실제)
73
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4K1
- McMaster Children's Hospital
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Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital Eastern Ontario
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Quebec
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Montreal, Quebec, 캐나다, H3T 1C5
- CHU Sainte-Justine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Parents and adolescents will be eligible to participate if the adolescents are:
- between 12-18 years of age
- diagnosed with cancer (at least 3 months from diagnosis)
- on active treatment
- able to speak and read English and/or French at a Grade 6 level
Exclusion Criteria:
Adolescents will be excluded if they:
- have major cognitive impairments
- have reduced executive function that may impact their ability to understand and use the online program
- are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 대조군
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The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention.
In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about Cancer ("Cancer Resource Centre") and online assessments.
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실험적: 책임 실험 그룹
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n addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing Cancer Online" Internet self-management program.
The intervention is a 12-module interactive multi-component treatment protocol that consists of Cancer-specific education, self-management strategies, and social support that is available in English and French.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant Accrual and Dropout Rates
기간: 12 weeks
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These rates will be centrally tracked by the Clinical Research Project Coordinator
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12 weeks
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Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)
기간: 12 weeks
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Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the Clinical Research Project Coordinator
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12 weeks
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Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)
기간: 12 weeks
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Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention
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12 weeks
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Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)
기간: 12 weeks
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Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knowledge (Adolescent Cancer Knowledge Questionnaire)
기간: 12 weeks
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Measured using the Adolescent Cancer Knowledge Questionnaire, a 15-item tool that assesses cancer-specific knowledge.
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12 weeks
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Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)
기간: 12 weeks
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Measured by the Generalized Self-Efficacy-Sherer Scale, a 12-item scale that requires adolescents to indicate their level of agreement with a series of statements about self-efficacy.
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12 weeks
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Treatment adherence (Medication Adherence Scale)
기간: 12 weeks
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Measured with the Medication Adherence Scale, a 4-item scale for assessing self-reported adherence.
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12 weeks
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Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)
기간: 12 weeks
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Measured using the short form Brief Pain Inventory (BPI), a 15-item measure that includes scales for measuring pain intensity, impact of pain on functioning and well being, and pain interference.
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12 weeks
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Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)
기간: 12 weeks
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Measured using the PedsQL Multidimensional Fatigue Module, an 18-item scale with validated versions for child report (ages 8-12 years), teen report (ages 13-18 years), and parental report for children and teens.
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12 weeks
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Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)
기간: 12 weeks
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Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for individuals aged >12 years, which can be completed within 2-5 minutes.
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12 weeks
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Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)
기간: 12 weeks
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Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support.
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12 weeks
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Transition readiness (Cancer Transition Scales)
기간: 12 weeks
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Measured with the Cancer Transition Scales, which include sub-scales for 'cancer worry' (6 items), 'self-management skills' (15 items), and 'expectations' (12 items).
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12 weeks
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Health Related Quality of Life (PedsQL Cancer Module)
기간: 12 weeks
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measured with the PedsQL Cancer Module, a 27-item scale, which has validated versions for child, teen, and parental report, and the Health Utility Index [HUI].
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12 weeks
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Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)
기간: 12 weeks
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Measured by ascertaining direct health care costs and family out of pocket costs related to cancer care incurred over the 12-week study period using the Health Care Utilization form modified from the Ambulatory and Home Care Record84-90 as well as direct costs related to the online intervention technology, intervention training and personnel.
Quality adjusted life years will be calculated using the HUI to determine the incremental cost-effectiveness
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12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Jennifer N Stinson, PhD, CPNP, The Hospital for Sick Children
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 1월 1일
기본 완료 (실제)
2019년 4월 1일
연구 완료 (실제)
2019년 4월 1일
연구 등록 날짜
최초 제출
2014년 11월 17일
QC 기준을 충족하는 최초 제출
2014년 11월 21일
처음 게시됨 (추정)
2014년 11월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 7일
마지막으로 확인됨
2019년 10월 1일
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. .