Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
Study Details
Study Description
Brief Summary
This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
Detailed Description
OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II. Patients who do not have elevated distress or low cardiometabolic or cancer health care adherence are assigned to Group 0.
ARM I (INTERVENTION): Patients receive a personalized smart cell phone (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month.
ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
GROUP 0: Patients have access to the digital INSPIRE program and receive printed SCP materials without telehealth.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (INSPIRE, telehealth care) Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month. |
Other: Internet Mobile Technology
Use INSPIRE mobile application
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Supportive Care
Receive telehealth stepped care
Other Names:
|
| Active Comparator: Arm II (control website) Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls. |
Other: Internet-Based Intervention
Access to a study-specific control website
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: Group 0 (INSPIRE, printed material) Patients have access to the digital INSPIRE program and receive printed SCP materials without telehealth. |
Other: Informational Intervention
Receive printed SCP materials
Other: Internet Mobile Technology
Use INSPIRE mobile application
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Distress score (3 months) [At 3 months]
Will be assessed by Cancer and Treatment Distress (CTXD). Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD.
Secondary Outcome Measures
- Distress score (12 months) [At 12 months]
Will be assessed by Cancer and Treatment Distress (CTXD). Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD.
- Proportion of healthcare adherence (HCA)-all [At 12 months]
Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.
- Proportion of HCA-cardiometabolic surveillance (CM) [At 12 months]
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM.
- Proportion of HCA-cancer surveillance (SM) [At 12 months]
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with a first invasive malignancy of leukemia, lymphoma, colorectal cancer, melanoma, or sarcoma (stage 1-3 for solid tumors) between the ages of 15-39 years
-
Currently within 1 to 5 years from the time of diagnosis
-
Completed active treatment for disease >= 6 months previously
-
Received a therapeutic intervention (with curative intent if advanced stage disease) that included any of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy
-
English proficiency adequate to complete assessments
-
Access to email and smartphone mobile app and or internet
Exclusion Criteria:
-
Diagnosed with a subsequent invasive malignancy other than non-melanoma skin cancer
-
Health issues prohibiting computer use or ability to comply with study procedures
-
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
-
Does not complete baseline patient reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 2 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 3 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 4 | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 5 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kevin Baker, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1121029
- NCI-2020-04792
- 10470
- U01CA246659