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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 : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : May 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

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 IA Cutaneous Melanoma AJCC v8 Clinical Stage IB Cutaneous Melanoma AJCC v8 Clinical Stage II Cutaneous Melanoma AJCC v8 Clinical Stage IIA Cutaneous Melanoma AJCC v8 Clinical Stage IIB Cutaneous Melanoma AJCC v8 Clinical Stage IIC Cutaneous Melanoma AJCC v8 Clinical Stage III Cutaneous Melanoma AJCC v8 Hematopoietic and Lymphoid Cell Neoplasm Invasive Malignant Neoplasm Leukemia Lymphoma Malignant Solid Neoplasm Pathologic Stage I Cutaneous Melanoma AJCC v8 Pathologic Stage IA Cutaneous Melanoma AJCC v8 Pathologic Stage IB Cutaneous Melanoma AJCC v8 Pathologic Stage II Cutaneous Melanoma AJCC v8 Pathologic Stage IIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIC Cutaneous Melanoma AJCC v8 Pathologic Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Sarcoma Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 Stage IIB Colorectal Cancer AJCC v8 Stage IIC Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Other: Informational Intervention Other: Internet Mobile Technology Other: Internet-Based Intervention Other: Questionnaire Administration Procedure: Supportive Care Phase 3

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. Patients who do not have elevated distress or low cardiometabolic or cancer health care adherence are assigned to Group 0.

ARM I (INTERVENTION): Patients receive a personalized smart cell phone (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.

GROUP 0: Patients have access to the digital INSPIRE program and receive printed SCP materials without telehealth.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


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

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

Active Comparator: Group 0 (INSPIRE, printed material)
Patients have access to the digital INSPIRE program and receive printed SCP materials without telehealth.
Other: Informational Intervention
Receive printed SCP materials

Other: Internet Mobile Technology
Use INSPIRE mobile application
Other Name: www-mobile

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Distress score (3 months) [ Time Frame: At 3 months ]
    Will be assessed by Cancer and Treatment Distress (CTXD). Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD.


Secondary Outcome Measures :
  1. Distress score (12 months) [ Time Frame: At 12 months ]
    Will be assessed by Cancer and Treatment Distress (CTXD). Patients will meet the primary endpoint for lack of distress if they score < 0.9 on the CTXD.

  2. 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.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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, colorectal cancer, melanoma, or sarcoma (stage 1-3 for solid tumors) between the ages of 15-39 years
  • 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:

  • Development of an invasive subsequent malignancy other than non-melanoma skin cancer in the past year or in active treatment for a subsequent malignancy
  • 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

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: Sheri Ballard 206.667.4222 sballard@fredhutch.org

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Contact: Patricia A. Ganz         
Principal Investigator: Patricia A. Ganz         
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Ann H. Partridge         
Principal Investigator: Ann H. Partridge         
United States, New York
Memorial Sloan Kettering Cancer Center
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
Philadelphia, Pennsylvania, United States, 19104
Contact: Linda Jacobs         
Principal Investigator: Linda Jacobs         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Contact: Sheri Ballard    206-667-4222    sballard@fredhutch.org   
Principal Investigator: Kevin Baker         
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kevin Baker Fred Hutch/University of Washington Cancer Consortium
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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: May 3, 2022
Last Verified: September 2021
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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Neoplasms
Colorectal Neoplasms
Melanoma
Skin Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
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
Skin Diseases