Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors

Phase 3

Not yet recruiting

• Conditions: Colorectal Cancer Stage II; Colorectal Cancer Stage III

• Registration Number: NCT07018869
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Study Start: 2025-10-21
• Primary Completion: 2029-03-23
• Study Completion: 2029-03-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1057

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."

  • 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Receipt of colorectal cancer surveillance	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.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy for managing follow-up care	At baseline, 3 months, and 16 months	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.
Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2 Profile version 2.1, Physical Function Measure only	At baseline, 3 months, and 16 months	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.
Satisfaction with supporter engagement questionnaire	At 3 months, and 16 months	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.
Knowledge About Colorectal Follow-Up Care score	At baseline, 3 months, and 16 months	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)	At baseline, 3 months, and 16 months	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	At baseline, 3 months, and 16 months	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.