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
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
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.
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:
I. To assess the implementation of CTAC into clinic workflow, and to better understand barriers and facilitators to the delivery of the intervention arm using a mixed-methods approach. (For the process evaluation of the CTAC intervention) II. To explore the association between supporter participation in the assigned CTAC intervention at 3 months with receipt of CRC surveillance at 16 months. (Regarding supporter participation) III. To explore the association between supporter participation in the assigned CTAC intervention at 3 months with knowledge about surveillance; at 16 months. (Regarding supporter participation) IV. To explore the association of supporter participation in the assigned CTAC intervention at 3 months with self-efficacy in management of surveillance at 16 months. (Regarding supporter participation) V. To explore the association of supporter participation in the assigned CTAC intervention at 3 months. (Regarding supporter participation)
OUTLINE: Patients are randomized to 1 of 2 groups and supporter participants are assigned to the arm to which their patient was randomized.
GROUP 1: Patients and supporter participants receive access to the CTAC intervention website and may review the content as frequently as they like for up to 16 months on study.
GROUP 2: Patients and supporter participants receive access to a general health education website and may review the content as frequently as they like for up to 16 months on study.
Inclusion Criteria:
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."
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
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
Anchorage, Alaska 98508, United States
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Ann Arbor, Michigan 48103, United States
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Saint Joseph, Michigan 49085, United States
Ypsilanti, Michigan 48197, United States
Crosslake, Minnesota 56442, United States
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International Falls, Minnesota 56649, United States
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