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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-39
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internet-Based Intervention

    Other intervention

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

  • Internet-Based Intervention

    Other intervention

    Receive access to Thrive Track website with general cancer-specific survivorship care information in addition to emotional support content

  • Interview

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Arm I (Thrive control)Active comparator 3 interventions
Group B: Arm II (Thrive Track with emotional support)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months post-enrollment
2

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.

Time frame
3 months post-enrollment

Secondary outcomes

1

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.

Time frame
3 months post-enrollment
2

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

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.

Time frame
At 3 months post-enrollment
3

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.

Time frame
At 3 months post-enrollment
4

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.

Time frame
At 3 months post-enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: