Personalized Cancer Support for Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Cancer related worry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (Thrive control)
Patients receive access to Thrive Track website with general cancer-specific survivorship care information for up to 3 months.
干预措施: Internet-Based Intervention (Other)
Arm I (Thrive control)
Patients receive access to Thrive Track website with general cancer-specific survivorship care information for up to 3 months.
干预措施: Questionnaire Administration (Other)
Arm I (Thrive control)
Patients receive access to Thrive Track website with general cancer-specific survivorship care information for up to 3 months.
干预措施: Interview (Other)
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.
干预措施: Interview (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Internet-Based Intervention (Other)
结局指标
主要结局
Cancer related worry
时间窗: 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
时间窗: 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.
次要结局
- 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)