Clinical Stage I Cutaneous Melanoma AJCC v8NCT04593277
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
A study testing Internet Mobile Technology, Internet-Based Intervention and Questionnaire Administration in people with Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage II Cutaneous Melanoma AJCC v8, run by Fred Hutchinson Cancer Center at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8
- What is being tested?
- Internet Mobile Technology, Internet-Based Intervention and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
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.
Read the 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.
- Conditions
- 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
- Being tested
- Internet Mobile Technology, Internet-Based Intervention, Questionnaire Administration, Supportive Care, Informational Intervention
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Sarcoma, Colorectal Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Mobile TechnologyOther
Also called www-mobile
Use INSPIRE mobile application
Internet-Based InterventionOther
Access to a study-specific control website
Questionnaire AdministrationOther
Ancillary studies
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive telehealth stepped care
Informational InterventionOther
Receive printed SCP materials
| Study group | Role | What they receive |
|---|---|---|
| Arm I (INSPIRE, telehealth care) | Experimental | Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month. Receives: Other: Internet Mobile Technology; Other: Questionnaire Administration; Procedure: Supportive Care; Other: Informational Intervention |
| Arm II (control website) | Active comparator | 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. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distress score 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.
Measured: From baseline to 3 months
Change in distress score 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.
Measured: From baseline to 12 months
Secondary outcomes (3)
Proportion of healthcare adherence (HCA)-all
Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.
Measured: At 12 months
Proportion of HCA-cardiometabolic surveillance (CM)
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM.
Measured: At 12 months
Proportion of HCA-cancer surveillance (SM)
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Oct 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage I Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- K. Scott Baker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593277
- Sponsor's protocol ID
- RG1121029
- Other IDs
- NCI-2020-04792, 10470, U01CA246659
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
- ClinicalTrials.gov ID
- NCT04593277
- Acronym / sponsor ID
- RG1121029
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (INSPIRE, telehealth care) | Experimental | Other: Internet Mobile Technology, Other: Questionnaire Administration, Procedure: Supportive Care, Other: Informational InterventionPatients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month. |
| Arm II (control website) | Active comparator | Other: Internet-Based Intervention, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Mobile TechnologyAlso: www-mobileUse INSPIRE mobile application | Other | Arm I (INSPIRE, telehealth care) |
| Internet-Based InterventionAccess to a study-specific control website | Other | Arm II (control website) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (INSPIRE, telehealth care), Arm II (control website) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive telehealth stepped care | Procedure or surgery | Arm I (INSPIRE, telehealth care) |
| Informational InterventionReceive printed SCP materials | Other | Arm I (INSPIRE, telehealth care) |
Primary outcome
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.
3 secondary outcomes
Proportion of healthcare adherence (HCA)-all
Time frame: At 12 months
Proportion of HCA-cardiometabolic surveillance (CM)
Time frame: At 12 months
Proportion of HCA-cancer surveillance (SM)
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. Scott Baker principal investigator
Fred Hutch/University of Washington Cancer Consortium
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Mobile Technology, Internet-Based Intervention and Questionnaire Administration in people with Clinical Stage I Cutaneous Melanoma AJCC v8 and Clinical Stage II Cutaneous Melanoma AJCC v8, run by Fred Hutchinson Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in distress score from baseline to 3 months (time frame: From baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.