Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1,029
- 主要终点
- Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
研究概览
简要总结
This clinical trial gathers information about adolescents and young adults (AYA) and patient reported outcomes data in Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) trials to improve the collection of AYA patient reported outcomes. This study may help doctors understand the needs of adolescent and young adult cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate feasibility and acceptability of completing patient reported outcomes (PROs) among AYAs randomized to Choice PRO versus (vs) Fixed PRO.
EXPLORATORY OBJECTIVES:
I. To evaluate AYAs' health-related quality of life (HRQOL) priorities and HRQOL PRO trajectories.
II. To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI).
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be >= 18 years and =< 39 years of age at registration
- •Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration
- •Patient must not have a recurrence or second primary cancer
- •Patients must not have basal cell skin carcinoma
- •Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy
- •Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Patient must have a life expectancy > 24 months
- •Patient must be able to complete questionnaires in English or in Spanish
- •Patient must have internet access through computer, tablet, or smartphone
- •Patient must have an email address
- •Patient must have a mobile phone able with text messaging capabilities
- •Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact)
- •Patient must be able to provide informed consent
- •Participation in clinical trials is not an exclusionary criterion in EAQ
- •Patients may be dually enrolled in EAQ202 as well as in therapeutic trials, including those involving checkpoint inhibitors
- •NOTE: We understand that some therapeutic trials may also collect PRO data (e.g., the cross-National Clinical Trials Network [NCTN] S1826 study in which ECOG-ACRIN is participating), thus creating a potential for overburdening patients. We will be attentive to informing all patients of this potential overburdening as they consider a voluntary decision to register for EAQ
- •We will coordinate with the PRO chair(s) of the therapeutic studies to ensure that the integrity of the PRO analyses be preserved
排除标准
- •Patient must not have a recurrence or second primary cancer. Patients must not have basal cell skin carcinoma.
研究组 & 干预措施
Arm I (choice PRO)
Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
干预措施: Quality-of-Life Assessment (Other)
Arm I (choice PRO)
Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
干预措施: Questionnaire Administration (Other)
Arm II (fixed PRO)
Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
干预措施: Questionnaire Administration (Other)
Arm II (fixed PRO)
Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
时间窗: Feasibility at 1 month and acceptability at baseline
Evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Feasibility of completing patient reported outcomes (PROs)
时间窗: At 1 month
Will be defined as \>= 75% completed PROs at one-month. Feasibility will be compared between two arms using the two-sample proportion tests based on two binomial distributions. Fisher's exact method will be used to calculate the p value. Potential moderators will include sociodemographic information (i.e., Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences \[PRAPARE\] form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting). Their effects will be evaluated using the logistic regression method with feasibility modeled as the binary response.
Acceptability of completing PROs
时间窗: Baseline
Will be defined as \>= 75% completed PROs at baseline. Acceptability will be compared between two arms using the two-sample proportion tests based on two binomial distributions. Fisher's exact method will be used to calculate the p value. Potential moderators will include sociodemographic information (i.e., PRAPARE form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting). Their effects will be evaluated using the logistic regression method with acceptability modeled as the binary response.
次要结局
未报告次要终点