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.
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.
None
Parallel
Intervention website access
Other interventionReceive access to CTAC intervention website with educational content and interactive modules
Control website access
Other interventionReceive access to CTAC control website with general health education
Interview
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Receipt of colorectal cancer surveillance
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.
Knowledge About Colorectal Follow-Up Care score
The Knowledge About Colorectal Follow-Up Care score is patterned after instruments used in prior research that measure knowledge about colorectal cancer screening. 5 questions are asked of participants about the purpose of colorectal cancer surveillance, what is included in surveillance, recommended timeframe for surveillance, recurrence, and odds of new colorectal cancer diagnosis compared to the general population. Each question will receive one point for a correct answer and 0 points for an incorrect answer. One question is written as "select all that apply"; all correct answers must be selected for the question to count as correctly answered. The number of correct answers will be summed to give an overall knowledge score (ranging from 0 to 5). Change in knowledge over time will be compared between the two arms using multivariable logistic regression. Regression models will adjust for the stratification variables as covariates.
Cancer Worry Scale (CWS)
8-item scale detecting fear of recurrence in cancer survivors, rated on a 4-item Likert scale ranging from "never" to "almost always." Scores range from 8 to 32, with a higher total score indicating greater worry about cancer and/or greater impact on mood and daily functioning. Multivariable logistic regression will be used. Regression models will adjust for the stratification variables as covariates.
Follow-up care preferences questionnaire
The follow-up care preferences questionnaire is a 9-item questionnaire that solicits participants' preferences about follow-up care (i.e., "When thinking about your colorectal cancer follow-up care, how important to you are the following?") with questions (e.g., "It keeps you from worrying about the cancer coming back") answered using a 5-item Likert scale ranging from "Not at all important" to "Very important." Changes in preferences over time will be described and reported by arm.
Self-efficacy for managing follow-up care
This scale is adapted with permission from a 6-item scale used to measure colorectal cancer screening self-efficacy. Responses to individual questions are scored from 1 to 5 with higher values representing higher self-efficacy. An overall score is calculated by averaging the individual question scores. Multivariable linear regression will be used for analysis. Regression models will adjust for the stratification variables as covariates.
Barriers and facilitators of intervention uptake and use
The analysis plan involves reviewing the audio recorded interviews and developing a coding scheme under each component of the Consolidated Framework for Implementation Research domains. This scheme will then be shared with the rest of the study team for review and discussion to pull out high level "themes" regarding barriers and facilitators of intervention uptake and use. These themes will be reported on in a subsequent usability manuscript.
Supporter participation/inclusion in the assigned intervention
Will evaluate the association between supporter participation in the assigned intervention (evaluated at 3 months) and the following patient outcomes (evaluated at 16 months): 1) patient receipt of CRC surveillance, 2) patient knowledge about surveillance, 3) patient self-efficacy in management of surveillance, and 4) patient satisfaction with supporter engagement. Supporter inclusion in the assigned intervention at 3 months will be determined from responses to the Satisfaction with Supporter Engagement questionnaire. Analyses will be conducted using multivariable logistic regression.
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SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
