A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention Called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,057
- 试验地点
- 680
- 主要终点
- Receipt of colorectal cancer surveillance
研究概览
简要总结
This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant). Surveillance care after resection of colorectal cancer is critical to detect potentially curable return of disease (recurrence), yet up to 60% of colorectal cancer survivors fail to receive surveillance. This may be due to a lack of knowledge about the purpose of surveillance care and the risks of cancer recurrence, or a lack of confidence for managing surveillance care. The CTAC intervention is an online education intervention designed to improve patients' knowledge about surveillance and their self-efficacy for managing surveillance, and to promote effective communication with supporters and supporter engagement in patients' surveillance in a way that is aligned with each patient's preferences. By increasing a patient's knowledge, self-efficacy, and satisfaction with their supporter's engagement in their care, the CTAC intervention may increase the number of patients who receive guideline-concordant surveillance care after resection of colorectal cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate whether the patients randomized to the Current Together After Cancer (CTAC) intervention website compared to the CTAC control website have higher rates of guideline-concordant colorectal cancer (CRC) surveillance at 12 months after registration.
SECONDARY OBJECTIVES:
I. To assess patient reported knowledge about surveillance at 3 and 16 months post-patient registration. (Comparing CTAC intervention versus [vs.] control) II. To assess patient reported self-efficacy in management of surveillance 3 and 16 months post-patient registration using previously developed CRC screening self-efficacy measure. (Comparing CTAC intervention vs. control) III. To assess patient reported satisfaction with supporter engagement in surveillance 3 and 16 months post-patient registration. (Comparing CTAC intervention vs. control)
EXPLORATORY OBJECTIVES:
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
- 是
入选标准
- •PATIENTS:
- •Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below
- •Patient participants must have an adult in their life who supports them in their colorectal cancer journey who they might be willing to invite to join them in viewing an educational website. This is determined via the question: "Do you have an adult in your life, such as a spouse/partner, family member or friend, who supports you with your colorectal cancer journey and may be willing to view a website with you? When we say, "supports you in your colorectal cancer journey", we mean things like, helping you keep and get to medical appointments, talking with you and/or your doctors about your cancer, or helping you make decisions about your cancer."
- •Those who respond "no" to the question above will be told that "Because this study is for patients and a supporter to view the website together, you are not eligible for this study, but there may be other studies you are eligible for in the future".
- •NOTE: The above question will be used to define "supporter" for purposes of this study. Examples of supporters include a spouse, partner, sibling, adult child, another family member, or friend.
- •NOTE: The supporter does not have to agree to participate in the study in order for the patient to be eligible for this study. Justification for requiring the enrolled patient to have a supporter (whether the supporter is invited or participates) is based on the study's underlying conceptual framework
- •Patient participants must not have recurrent or metastatic (stage IV) colorectal cancer
- •Patient participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the efficacy assessment of this intervention
- •Patient participants must be registered within 90 - 180 days of surgical resection
- •Patient participants must be ≥ 18 years of age at the time of registration/randomization. The lower cutoff of 18 was determined because the lower age range of patients that may be recruited to Southwest Oncology Group (SWOG) studies is 18
- •Patient participants must have Zubrod performance status of 0-2
- •Patient participants must be able to read English or Spanish since the website for the intervention and control arm are available in English and Spanish
- •Patient participants must: 1) be able to complete Patient Reported Outcome (PRO) questionnaires in English or Spanish, and 2) agree to complete PROs at all scheduled timepoints
- •Patient participants will be encouraged to provide an email address or cell phone number, if possible, for the purpose of being contacted by staff at the University of Michigan who will provide access to the educational website. For those who do not wish to provide or create an email address or a cell phone number, they may still participate with alternate methods
- •Patient participants must not be enrolled or be planning to enroll in a clinical trial of investigational treatment that includes imaging and/or laboratory monitoring for the duration of this trial
- •NOTE: Patient participants are allowed to be co-enrolled on other non-treatment clinical trials
- •SUPPORTER PARTICIPANT:
- •Supporter participants must be ≥ 18 years of age at the time of registration/randomization
- •Supporter participants must be able to read English or Spanish since the educational website is available in English and Spanish
- •Supporter participants must have been identified by the patient as a person who may be willing to join them in reviewing the educational website
- •PATIENT AND SUPPORTER:
- •NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- •Patient and supporter participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative
排除标准
- 未提供
结局指标
主要结局
Receipt of colorectal cancer surveillance
时间窗: At 16 months
Receipt of the four surveillance components will be abstracted as a binary outcome (yes versus no) from the electronic medical record for every enrolled patient. Additionally, patient-reported receipt of surveillance will be collected via survey. Multivariable logistic regression will be used, adjusted for the stratification factors as covariates.
次要结局
- Knowledge About Colorectal Follow-Up Care score(At baseline, 3 months, and 16 months)
- Cancer Worry Scale (CWS)(At baseline, 3 months, and 16 months)
- Follow-up care preferences questionnaire(At baseline, 3 months, and 16 months)
- Self-efficacy for managing follow-up care(At baseline, 3 months, and 16 months)
- Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2 Profile version 2.1, Physical Function Measure only(At baseline, 3 months, and 16 months)
- Satisfaction with supporter engagement questionnaire(At 3 months, and 16 months)