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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Megan Haymart, MD
- Phone Number: 734-615-6745
- Email: support@thrivetrack.study
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
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Contact:
- Megan R. Haymart, MD
- Phone Number: 734-615-6745
- Email: support@thrivetrack.study
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Principal Investigator:
- Megan R. Haymart, MD
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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.
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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
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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
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:
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
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|
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
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.
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3 months post-enrollment
|
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Confidence/self-efficacy in the ability to self-manage worry
Time Frame: At 3 months post-enrollment
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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
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Resilience
Time Frame: At 3 months post-enrollment
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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
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Ease of tool use
Time Frame: At 3 months post-enrollment
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This outcome will be evaluated using a series of 7 questions designed to help understand the participants' experience using the Thrive Track website.
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At 3 months post-enrollment
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Megan R Haymart, MD, University of Michigan Rogel Cancer Center
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Male Urogenital Diseases
- Neoplasms by Histologic Type
- Thyroid Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Gonadal Disorders
- Skin Diseases
- Carcinoma
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Thyroid Diseases
- Testicular Diseases
- Adenocarcinoma, Papillary
- Skin and Connective Tissue Diseases
- Thyroid Cancer, Papillary
- Melanoma
- Adenocarcinoma, Follicular
- Testicular Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
Other Study ID Numbers
Other Study ID Numbers
- UMCC 2025.051
- NCI-2026-00929 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HUM00270736 (Other Identifier: University of Michigan Rogel Cancer Center)
- R34CA286602 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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