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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Receive access to Thrive Track website with general cancer-specific survivorship care information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cancer related worry | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge about worry self-management | 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 |
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Inclusion Criteria:
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)
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)
PARTICIPANTS RECRUITED FROM THYCA: Subjects that do not meet the inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Haymart, MD | Contact | 734-615-6745 | support@thrivetrack.study |
| Name | Affiliation | Role |
|---|---|---|
| Megan R Haymart, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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.
At the end of the study period
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.
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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.
| Internet-Based Intervention | Other | Receive access to Thrive Track website with general cancer-specific survivorship care information in addition to emotional support content |
|
| Interview | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
|
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 | 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 | 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 |
| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D008545 | Melanoma |
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D000231 | Adenocarcinoma, Papillary |
| D013964 | Thyroid Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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