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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593277
• Other study ID #: RG1121029
• Secondary ID: NCI-2020-0479210
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Study Intake
• Phone: 888-344-5678
• Email: inspire-aya[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Clinical Stage I Cutaneous Melanoma AJCC v8
• Clinical Stage II Cutaneous Melanoma AJCC v8
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Colorectal Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• Invasive Malignant Neoplasm
• Leukemia
• Lymphoma
• Malignant Solid Neoplasm
• Melanoma
• Neoplasms
• Sarcoma
• Skin Neoplasms
• Stage I Colorectal Cancer AJCC v8
• Stage II Colorectal Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Thyroid Gland Carcinoma
• Thyroid Neoplasms

Intervention

Other:
• Internet Mobile Technology
Use INSPIRE mobile application
• Internet-Based Intervention
Access to a study-specific control website
• Questionnaire Administration
Ancillary studies

Procedure:
• Supportive Care
Receive telehealth stepped care

Other:
• Informational Intervention
Receive printed SCP materials

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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