COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 2
- 主要终点
- Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
研究概览
简要总结
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1)
II. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to decrease distress (anxiety, depression and cancer specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate the uptake of remote genetic counseling (Step 2)
IV. To evaluate the uptake of germline testing among advanced cancer patients with a potential clinically significant incidental germline mutation identified through tumor profiling in the Molecular Analysis for Therapy Choice (MATCH) trial. (Step 2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
- •Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
- •Patients must speak English and have an adequate ability to view a website (primary intervention study)
- •(STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
- •Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
- •Patients must be able to speak English and hear by phone
排除标准
- 未提供
研究组 & 干预措施
Arm A (Step 1: internet-based intervention)
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
干预措施: Internet-Based Intervention (Other)
Arm A (Step 1: internet-based intervention)
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
干预措施: Survey Administration (Other)
Arm B (Step 1: usual care control)
Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
干预措施: Survey Administration (Other)
Arm B (Step 1: usual care control)
Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
干预措施: standard genetic education (Other)
Step 2 - genetic counseling
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
干预措施: Genetic Counseling (Other)
Step 2 - genetic counseling
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
干预措施: Genetic Testing (Other)
Step 2 - genetic counseling
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
干预措施: Survey Administration (Other)
结局指标
主要结局
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
时间窗: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education
时间窗: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
时间窗: Assessed at baseline at Step 2
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)
时间窗: Assessed at baseline at Step 2
Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education
时间窗: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education
时间窗: Assessed at baseline and up to 14 days post-baseline
There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.
次要结局
- Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex(Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline))
- Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex(Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline))
- Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex(Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline))
- Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex(Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline))