Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, 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 II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Thyroid Gland Carcinoma

Intervention / Treatment
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* Other: Internet Mobile Technology
* Other: Internet-Based Intervention
* Other: Questionnaire Administration
* Procedure: Supportive Care
* Other: Informational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (INSPIRE, telehealth care)<br>Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month. | Other: Internet Mobile Technology<br>* Use INSPIRE mobile application<br>* Other names: www-mobile;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Supportive Care<br>* Receive telehealth stepped care<br>* Other names: Therapy, Supportive;Other: Informational Intervention<br>* Receive printed SCP materials<br>|
| Active Comparator: Arm II (control website)<br>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<br>* Access to a study-specific control website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distress score from baseline to 3 months | Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD. | From baseline to 3 months | 
| Change in distress score from baseline to 12 months | Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD. | From baseline to 12 months | 
| Proportion of HCA-cardiometabolic surveillance (CM) | Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM. | At 12 months | 
| Proportion of HCA-cancer surveillance (SM) | Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of healthcare adherence (HCA)-all | Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all. | At 12 months |