my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT
研究概览
简要总结
This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
详细描述
This multi-center, pilot study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. My.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
Participants in this research study will be randomized into 1 of 2 study groups: my.naviGATE Group versus Usual Care Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include questionnaires or surveys, use of the mobile app for those randomized to the intervention, and qualitative interviews with study personnel for a subset of participants.
It is expected about 143 people will participate in this research study.
The Hyundai Hope On Wheels Foundation is supporting this research study by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.
- •Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.
- •Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia/Lymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.
- •Patients whose treatment includes alkylators, anthracyclines, and/or radiation.
- •Inclusion of Children:
- •This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be <18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and/or those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.
排除标准
- •Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.
- •Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.
- •Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.
- •We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.
研究组 & 干预措施
my.naviGATE Group
Participants will be randomized in a 1:1 ratio to this study group and will complete the following:
- Baseline survey
- 1 month survey
- 6 month survey
- Virtual interview (subset of participants)
干预措施: my.naviGATE Digital Tool (Behavioral)
Usual Care Group
Participants will be randomized in a 1:1 ratio to this study group and will receive standard oncology care and will complete the following:
- Baseline survey
- 1 month survey
- 6 month survey
结局指标
主要结局
Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT
时间窗: Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
The Patient Activation Measure (PAM-13) is a validated, self-administered questionnaire assessing knowledge, skills, and confidence for self health-management. It has 13 items with a standardized score from 1-100 derived from 4-point Likert scale answer choices ranging from "Disagree Strongly" to "Agree Strongly;" a higher standardized score represents greater activation.
Application (App) Feasibility Rate (Intervention Group)
时间窗: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
App feasibility rate is the proportion of participants in the intervention group ever using the my.naviGATE app. Usage metrics are collected through the app development platform.
Application (App) Acceptability Rate (Intervention Group)
时间窗: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
App acceptability will be assessed in the intervention group with an adapted acceptability electronic (E)-scale for web-based PROs in cancer care. Acceptability rate is the proportion of patients achieving acceptability on the 3-item scale, each using the 5-point Likert scale (1=lowest acceptability/not acceptable to 5 highest acceptability). The score ranges from 3-15 points and a score of 12 or higher indicates acceptability. (Tariman et al. Appl Nurs Res. 2011)
次要结局
- Patient Assessment of Cancer Communication Experiences (PACE) Scale Score (Treatment Completed Set) at 6 Months Post-EOT(Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months))
- Preparedness for Survivorship Score at 6 Months Post-EOT(Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months))
- Self-Efficacy Score at 6 Months Post-EOT(Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score Change at 6 Months Post-EOT(Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months))
研究者
Katie Greenzang,MD
Sponsor-Investigator
Dana-Farber Cancer Institute