A Phase 3 interventional study of Intervention website access and Control website access in Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by SWOG Cancer Research Network. Recruiting at 384 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Health services research
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 1,057 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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 be enrolled or be planning to enroll in a clinical trial of treatment that includes imaging and/or laboratory monitoring for the duration of this trial
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Intervention website access · Other: Interview · Other: Questionnaire Administration
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.
Other: Control website access · Other: Interview · Other: Questionnaire Administration
Receive access to CTAC intervention website with educational content and interactive modules
Receive access to CTAC control website with general health education
Ancillary studies
Ancillary 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.
Time frame: At 16 months
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.
Time frame: At baseline, 3 months, and 16 months
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.
Time frame: At baseline, 3 months, and 16 months
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.
Time frame: At baseline, 3 months, and 16 months
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.
Time frame: At baseline, 3 months, and 16 months
Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2 Profile version 2.1, Physical Function Measure only
Physical Function (PF) Measure taken from PROMIS-29+2 Profile version 2.1. 4 questions measuring ability to perform standard physical daily tasks. Individual questions are rated on Likert scale from "Unable to do" to "Without any difficulty." Scores are generally converted to T-Scores, with a mean of 50 and a standard deviation of 10 in the general population. Higher scores represent better physical function. Multivariable linear regression will be performed with stratification factors included as covariates.
Time frame: At baseline, 3 months, and 16 months
Satisfaction with supporter engagement questionnaire
The satisfaction with supporter engagement questionnaire consists of two parts: questions measuring overall satisfaction with the supporter's involvement in the participant's colorectal cancer follow-up care (4 items, each rated on a 5-level Likert scale; completed at 3 months and 16 months) and one question asking about whether the participant chose to invite a supporter and whether the participant and supporter viewed their assigned website together (this question completed only at the 3-month timepoint). Each question will be reported and analyzed separately with multivariate linear regression using stratification factors as covariates.
Time frame: At 3 months, and 16 months
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.
Time frame: Up to 16 months
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.
Time frame: Up to 16 months
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