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Completed

NCT Number: NCT04593277

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

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.

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Key information

Conditions

Clinical Stage I Cutaneous Melanoma AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Clinical Stage II Cutaneous Melanoma AJCC v8 Clinical Stage III Cutaneous Melanoma AJCC v8 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Invasive Malignant Neoplasm Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Malignant Solid Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Rectal Diseases Sarcoma Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Thyroid Diseases Thyroid Gland Carcinoma Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet Mobile Technology

Other

Use INSPIRE mobile application

Other names: www-mobile

Internet-Based Intervention

Other

Access to a study-specific control website

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Procedure

Receive telehealth stepped care

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Informational intervention

Other

Receive printed SCP materials

Primary outcomes

  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.

Secondary outcomes

  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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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