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| Name | Class |
|---|---|
| Hyundai Hope On Wheels | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| my.naviGATE Group | Experimental | Participants will be randomized in a 1:1 ratio to this study group and will complete the following:
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| Usual Care Group | No Intervention | Participants will be randomized in a 1:1 ratio to this study group and will receive standard oncology care and will complete the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| my.naviGATE Digital Tool | Behavioral | : A HIPAA-compliant digital health intervention in the form of a mobile application that provides personalized cancer survivorship education based on individual treatment regimens, virtual visits with trained peer navigators, and collection questionnaires/survey responses. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT | 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. | Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| Application (App) Feasibility Rate (Intervention Group) | 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. | Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| Application (App) Acceptability Rate (Intervention Group) | 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) | Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Cancer Communication Experiences (PACE) Scale Score (Treatment Completed Set) at 6 Months Post-EOT | The PACE Scale (treatment completed set) is a 6-item questionnaire assessing communication and support experiences during and after cancer treatment. Questions are rated on a Likert-style scale ranging from "Never" to "Always" or "Poor" to "Excellent." Across a sample of patients with a variety of cancers, 70% rated post-cancer treatment communication as excellent. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Greenzang, MD | Contact | 6176325992 | katie_greenzang@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katie Greenzang, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
DFCI- Contact the Beffer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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| Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| Preparedness for Survivorship Score at 6 Months Post-EOT | Preparedness for survivorship is measured on a 10-item scale with response items ranging from "strongly agree" (4) to "strongly disagree" (1) or "strongly satisfied" (5) to "not at all satisfied" (1); higher mean composite scores suggests increased perceived preparedness for survivorship. | Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| Self-Efficacy Score at 6 Months Post-EOT | Self-efficacy for late effect and survivorship care planning will be measured by two adapted 3-item self-efficacy scales. The mean of the Late Effects Self-Efficacy scale is 3.3 (SD=1.1), and the mean of the Survivorship Care Planning Self-Efficacy scale is 3.9 (SD=1.2). Items are rated from 1=not confident to 5=extremely confident; higher scores suggest greater perceived self-efficacy. | 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 | The 9-item PROMIS Pediatric Scale for Global Health (participant age <18) and 10-item PROMIS Scale for Global Health (participant age 18+) are validated measures of health-related quality of life (HRQoL). Responses are scored on a scale of 1-5, and the total score is converted to a T-score with a mean of 50 and a standard deviation (SD) fixed at 10. Higher scores suggest better perceived HRQoL. The final question on the adult version is scored 1-10. | Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months) |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008527 | Medulloblastoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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