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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593277
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : March 21, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Other: Internet Mobile Technology Other: Internet-Based Intervention Other: Questionnaire Administration Procedure: Supportive Care Other: Informational Intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
Actual Study Start Date : October 23, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Internet Mobile Technology
Use INSPIRE mobile application
Other Name: www-mobile

Other: Questionnaire Administration
Ancillary studies

Procedure: Supportive Care
Receive telehealth stepped care
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

Other: Informational Intervention
Receive printed SCP materials
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.
 Other: Internet-Based Intervention
Access to a study-specific control website

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Change in distress score from baseline to 3 months [ Time Frame: 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.

  2. Change in distress score from baseline to 12 months [ Time Frame: 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.

  3. Proportion of HCA-cardiometabolic surveillance (CM) [ Time Frame: At 12 months ]
    Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM.

  4. Proportion of HCA-cancer surveillance (SM) [ Time Frame: At 12 months ]
    Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.


Secondary Outcome Measures :
  1. Proportion of healthcare adherence (HCA)-all [ Time Frame: At 12 months ]
    Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593277


Contacts
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Contact: Study Intake 888-344-5678 inspire-aya@fredhutch.org

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Patricia A. Ganz         
Principal Investigator: Patricia A. Ganz         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ann H. Partridge         
Principal Investigator: Ann H. Partridge         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Danielle N. Friedman         
Principal Investigator: Danielle N. Friedman         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Linda Jacobs         
Principal Investigator: Linda Jacobs         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Study Intake    888-344-5678    inspire-aya@fredhutch.org   
Principal Investigator: K. Scott Baker         
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: K. Scott Baker Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT04593277    
Other Study ID Numbers: RG1121029
NCI-2020-04792 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10470 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
U01CA246659 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Colorectal Neoplasms
Melanoma
Melanoma, Cutaneous Malignant
Skin Neoplasms
Thyroid Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases