Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial

Personalized Cancer Support for Young Adults

This pilot clinical trial is intended to compare the effect of a psychosocial support tool for young adult (YA)cancer survivors - including high-quality information about their cancer combined with evidence-based psychosocial support - to a support tool providing cancer-specific information alone (minus psychosocial modules). This tool, called Thrive Track, will be for YA patients aged 20-39 with thyroid, melanoma, or testicular cancer. Young adult survivors frequently experience persistent worry and distress that can interfere with coping and reduce quality of life. They are also particularly vulnerable to the emotional impact of cancer and may not have adequate support to manage these concerns. The enhanced version of Thrive Track includes personalized emotional support content and strategies designed to help patients better manage worry and distress. Adding these emotional support tools may provide greater benefit than survivorship education alone in strengthening young adult survivors' ability to manage their emotional well-being.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
        • Contact:
        • Principal Investigator:
          • Megan R. Haymart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PARTICIPANTS RECRUITED FROM SURVEILLANCE, EPIDEMIOLOGY, AND END RESULTS PROGRAM (SEER)-GEORGIA: Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer), melanoma, or testicular cancer at any stage and reported to the SEER-Georgia registry
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: 2-10 years after diagnosis with cancer
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: English speaking (able to read and speak English)
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate "not at all" will be told the study is focused on those who experience worry)
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Residing in the United States
  • PARTICIPANTS RECRUITED FROM THYROID CANCER SURVIVORS' ASSOCIATION INC. (THYCA): Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment
  • PARTICIPANTS RECRUITED FROM THYCA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer) at any stage
  • PARTICIPANTS RECRUITED FROM THYCA: 2-10 years after diagnosis with cancer
  • PARTICIPANTS RECRUITED FROM THYCA: English speaking (able to read and speak English)
  • PARTICIPANTS RECRUITED FROM THYCA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate "not at all" will be told the study is focused on those who experience worry)
  • PARTICIPANTS RECRUITED FROM THYCA: Residing in the United States

Exclusion Criteria:

  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects from certain vulnerable populations will be excluded as appropriate: fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)

    • It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman
  • PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects that do not meet the inclusion criteria
  • PARTICIPANTS RECRUITED FROM THYCA: Subjects from certain vulnerable populations will be excluded as appropriate fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)

    • It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman
  • PARTICIPANTS RECRUITED FROM THYCA: Subjects that do not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (Thrive control)
Patients receive access to Thrive Track website with general cancer-specific survivorship care information for up to 3 months.
Ancillary studies
Ancillary studies
Receive access to Thrive Track website with general cancer-specific survivorship care information
Receive access to Thrive Track website with general cancer-specific survivorship care information in addition to emotional support content
Experimental: Arm II (Thrive Track with emotional support)
Patients receive access to Thrive Track website with general cancer-specific survivorship care information in addition to emotional support content for up to 3 months.
Ancillary studies
Ancillary studies
Receive access to Thrive Track website with general cancer-specific survivorship care information
Receive access to Thrive Track website with general cancer-specific survivorship care information in addition to emotional support content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer related worry
Time Frame: 3 months post-enrollment

Cancer-related worry will be evaluated using two 8-item validated scales:

  1. Cancer Worry Scale (CWS)
  2. An adapted cancer worry scale

Overall as well as stratified analyses (by recruitment source and cancer type) will be performed. We will compare mean scores on the two scales between intervention and control subjects at 3 months post intervention. Scores on the CWS scale range from 8 (minimum) to 32 (maximum), with lower scores indicating less cancer-related worry and more favorable outcomes.

Scores on the adapted cancer worry scale range from 8 (minimum) to 40 (maximum), with lower scores indicating less cancer-related worry and more favorable outcomes.

3 months post-enrollment
Cancer related distress
Time Frame: 3 months post-enrollment

Cancer-related distress will be measured using the National Comprehensive Cancer Network Distress Thermometer.

Scores on the NCCN Distress Thermometer range from 0 (minimum) to 10 (maximum), with lower scores indicating less distress and more favorable outcomes.

Overall as well as stratified analyses (by recruitment source and cancer type) will be performed. We will compare mean scores on the distress thermometer between the intervention and control subjects at 3 months post-intervention using two-sample t-tests.

3 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about worry self-management
Time Frame: 3 months post-enrollment
This outcome will be evaluated using a team-developed 4-item scale. Scores on this scale range from 4 (minimum) to 16 (maximum), with higher scores indicating better knowledge about how to self-manage worry and more favorable outcomes.
3 months post-enrollment
Confidence/self-efficacy in the ability to self-manage worry
Time Frame: At 3 months post-enrollment

This outcome will be evaluated using an 11-item scale from the Breast Cancer Self Efficacy Scale (BCSE), adapted for all cancers.

Scores on this scale range from 11 (minimum) to 55 (maximum), with higher scores indicating better self efficacy to manage cancer-related worry and more favorable outcomes.

At 3 months post-enrollment
Resilience
Time Frame: At 3 months post-enrollment

This outcome will be evaluated using a 6-item validated scale, adapted from the Communication and Attitudinal Self-Efficacy Scale (CASE) and the Cancer Control and Outlook Scale.

Scores on this scale range from 6 (minimum) to 30 (maximum), with higher scores indicating better resilience to deal with cancer and more favorable outcomes.

At 3 months post-enrollment
Ease of tool use
Time Frame: At 3 months post-enrollment
This outcome will be evaluated using a series of 7 questions designed to help understand the participants' experience using the Thrive Track website.
At 3 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Megan R Haymart, MD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As described in our Data Management and Sharing plan (DMS), all the final data generated from this study will be de-identified and uploaded to the Inter-University Consortium for Political and Social Research (ICPSR). Additionally, the primary outcome results of the study will be reported to ClinicalTrials.gov no later than 1 year after the primary completion date of the trial.

IPD Sharing Time Frame

At the end of the study period

IPD Sharing Access Criteria

Final data generated from this trial can be requested from ICPSR. All researchers requesting the data will need to complete a questionnaire that will include investigator name(s), institution(s), discipline(s), and initial research question(s). We also shall request each applicant to submit to ICPSR the citations of any peer-reviewed presentations and publications. No data-sharing agreement will be required. This data will be accessible for 10 years after it has been uploaded to the ICPSR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.