Differentiated Thyroid Gland Carcinoma, Malignant Testicular Neoplasm, Melanoma, Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma
Conditions
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.
Interventions
OTHERInternet-Based Intervention
Receive access to Thrive Track website with general cancer-specific survivorship care information
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer related worry | 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. |
| Cancer related distress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge about worry self-management | 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. |
| Confidence/self-efficacy in the ability to self-manage worry | 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. |
| Resilience | 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. |
| Ease of tool use | 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. |
Countries
United States
Contacts
CONTACTMegan Haymart, MD
PRINCIPAL_INVESTIGATORMegan R Haymart, MD
University of Michigan Rogel Cancer Center
Outcome results
None listed