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

• ClinicalTrials.gov Identifier: NCT04593277
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: March 21, 2024
• Sponsor: Fred Hutchinson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Fred Hutchinson Cancer Center

Tracking Information

• First Submitted Date: October 6, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: March 21, 2024
• Actual Study Start Date: October 23, 2022
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 17, 2023)

• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: October 16, 2020)

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.

Current Secondary Outcome Measures (submitted: February 17, 2023)

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.

Original Secondary Outcome Measures (submitted: October 16, 2020)

• 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.
• 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.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
• Official Title: INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• 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

Intervention

• Other: Internet Mobile Technology
  Use INSPIRE mobile application
  Other Name: www-mobile
• Other: Internet-Based Intervention
  Access to a study-specific control website
• 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

Study 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.
  Interventions:

  • Other: Internet Mobile Technology
  • Other: Questionnaire Administration
  • Procedure: Supportive Care
  • Other: Informational Intervention
• 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-Based Intervention
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 7, 2023): 700
• Original Estimated Enrollment (submitted: October 16, 2020): 1200
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fred Hutchinson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Fred Hutchinson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: K. Scott Baker; Fred Hutch/University of Washington Cancer Consortium

• PRS Account: Fred Hutchinson Cancer Center
• Verification Date: March 2024