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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04593277
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fred Hutchinson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

K. Scott Baker
Principal Investigator Affiliation Fred Hutch/University of Washington Cancer Consortium
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Other: - Internet Mobile Technology

Use INSPIRE mobile application

Other: - Internet-Based Intervention

Access to a study-specific control website

Other: - Questionnaire Administration

Ancillary studies

Procedure: - Supportive Care

Receive telehealth stepped care

Other: - Informational Intervention

Receive printed SCP materials

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Site Contact

Patricia A. Ganz

[email protected]

888-344-5678

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Ann H. Partridge

[email protected]

888-344-5678

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Danielle N. Friedman

[email protected]

888-344-5678

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Site Contact

Linda Jacobs

[email protected]

888-344-5678

Seattle, Washington

Status

Recruiting

Address

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Site Contact

Study Intake

[email protected]

888-344-5678

Stay Informed & Connected