Clinical trial NCT04593277: Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
Official title: INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Clinical Stage I Cutaneous Melanoma AJCC v8
Clinical Stage II Cutaneous Melanoma AJCC v8
Clinical Stage III Cutaneous Melanoma AJCC v8
Hematopoietic and Lymphoid Cell Neoplasm
Invasive Malignant Neoplasm
Leukemia
Lymphoma
Malignant Solid Neoplasm
Sarcoma
Stage I Colorectal Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Thyroid Gland Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-19
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a first invasive malignancy of leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer (stage 1-3 for solid tumors) between the ages of 15-39 years
* Current age \>= 18 when approached
* 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
* Received hematopoietic stem cell transplant
* 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

Primary outcomes:
measure: Change in distress score from baseline to 3 months
timeFrame: From baseline to 3 months
measure: Change in distress score from baseline to 12 months
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Proportion of healthcare adherence (HCA)-all
timeFrame: At 12 months
measure: Proportion of HCA-cardiometabolic surveillance (CM)
timeFrame: At 12 months
measure: Proportion of HCA-cancer surveillance (SM)
timeFrame: At 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: K. Scott Baker
role: PRINCIPAL_INVESTIGATOR
References: