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

NCT ID: NCT04593277

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

549 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-23

Study Completion Date

2025-12-31

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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Internet Mobile Technology

Intervention Type OTHER

Use INSPIRE mobile application

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type PROCEDURE

Receive telehealth stepped care

Informational Intervention

Intervention Type OTHER

Receive printed SCP materials

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.

Group Type ACTIVE_COMPARATOR

Internet-Based Intervention

Intervention Type OTHER

Access to a study-specific control website

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Internet Mobile Technology

Use INSPIRE mobile application

Intervention Type OTHER

Internet-Based Intervention

Access to a study-specific control website

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Supportive Care

Receive telehealth stepped care

Intervention Type PROCEDURE

Informational Intervention

Receive printed SCP materials

Intervention Type OTHER

Other Intervention Names

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www-mobile Supportive Therapy Symptom Management Therapy, Supportive

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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K. Scott Baker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2020-04792

Identifier Type: REGISTRY

Identifier Source: secondary_id

10470

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA246659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1121029

Identifier Type: -

Identifier Source: org_study_id

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