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

NCT07529080 | Not Yet Recruiting DMC

• 4 other identifiers: UMCC 2025.051NCI-2026-00929HUM00270736R34CA286602
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Differentiated Thyroid Gland Carcinoma; Malignant Testicular Neoplasm; Melanoma; Thyroid Gland Follicular Carcinoma; Thyroid Gland Papillary Carcinoma

Outcome Measures

Primary Outcomes (2)

• Cancer related worry

  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

  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 Outcomes (4)

• Knowledge about worry self-management

  3 months post-enrollment

• Confidence/self-efficacy in the ability to self-manage worry

  At 3 months post-enrollment

• Resilience

  At 3 months post-enrollment

• Ease of tool use

  At 3 months post-enrollment

Study Arms (2)

Arm I (Thrive control)

ACTIVE COMPARATOR

Patients receive access to Thrive Track website with general cancer-specific survivorship care information for up to 3 months.

Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration

Arm II (Thrive Track with emotional support)

EXPERIMENTAL

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.

Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Receive access to Thrive Track website with general cancer-specific survivorship care information

Arm I (Thrive control)

Interview OTHER

Ancillary studies

Arm I (Thrive control); Arm II (Thrive Track with emotional support)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Thrive control); Arm II (Thrive Track with emotional support)

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Melanoma; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma, Papillary; Thyroid Neoplasms; Head and Neck Neoplasms; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Megan R Haymart, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Haymart, MD

CONTACT

734-615-6745; support@thrivetrack.study

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to study arm. Both versions of Thrive Track have identical appearance; the only difference is that the intervention arm includes the added psychosocial content.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At the end of the study period
• 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.

Locations

US (1)