Proof-of-Concept of an Infrastructure for Text Messaging Interventions at CHOP: Development and Evaluation of THRIVE (Texting Health Resources to Inform, motiVate, and Engage)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment
研究概览
简要总结
Investigators will test the feasibility and acceptability, as well as efficacy (exploratory aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and importance of continued engagement in care, while also providing support and improving efficacy to achieve health-related goals.
详细描述
Adolescents and young adults (AYA) with cancer are recognized as an understudied and underserved population in oncology. AYA engagement in ongoing disease management is compromised by lack of awareness of their continued health vulnerabilities and need for continued care, their desire to be "normal" and remove themselves from the cancer experience, and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those completing active treatment, are extremely vulnerable and in need of support to maintain remission and assure optimal health into adulthood. To address the immediate need for innovative interventions targeting AYA completing cancer treatment, the proposed study will test the efficacy, feasibility, and acceptability of a tailored text messaging intervention for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform, motiVate, and Engage).
A pilot randomized controlled trial testing the acceptability and feasibility (primary) and initial efficacy (secondary) of a health promoting mobile health texting intervention with AYA transitioning off active cancer treatment to follow-up care.
The intervention compares a texting intervention to a receipt of an AYA survivorship handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include measures of knowledge, healthcare utilization, adherence, engagement in care, and psychosocial well-being measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer
- •Males or females between the ages of 12 and 25
- •In remission (per documentation in chart)
- •Within 12 months of completing active treatment for cancer
- •Cognitively capable to complete measures (per documentation in chart of impairment or parent or provider report).
- •Able to read and speak English.
- •Parent available to provide consent for those ages 12 to 17
排除标准
- •Subjects that do not meet inclusion criteria described above will be excluded.
研究组 & 干预措施
Intervention group
Receive daily text messages
干预措施: text messages (Behavioral)
Control group
No text messages, only written educational materials
结局指标
主要结局
Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment
时间窗: 16 weeks
All patients will complete a measure of acceptability at the outcome data collection-. The questionnaire consists of 27 items for the control group and 31 items for the intervention group. Items will be answered on a Likert-scale and one open-ended question intended to elicit suggestions for improving the intervention. Items pertain to perceived value, appropriateness, convenience and helpfulness of the intervention.
Number of patients completed 16 week measures
时间窗: 16 weeks
Completion of follow-up measures which will be logged by research team for feasibility
Number of patient-reported barriers to technology of text messages
时间窗: 16 weeks
Number of participants who report barriers or issues with the text messages and technology for feasibility
次要结局
- Fatigue(16 weeks)
- Changes in health competence beliefs(16 weeks)
- Changes in sleep quality(16 weeks)
- Attainment of health related goals(week 1 and 16)
- Health competence beliefs(16 weeks)
- Engagement in health promoting behaviors(16 weeks)
- Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer(16 weeks)
- Patient adherence to clinic attendance(16 weeks)
- Knowledge of health promoting behaviors(16 weeks)
- Patient adherence to medication compliance(26 weeks)
- Medication adherence(16 weeks)