Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 5:10 AM
Study NCT ID:
NCT07018869
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-03080 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| S2417CD | OTHER | SWOG | View | |
| SWOG-S2417CD | OTHER | DCP | View | |
| S2417CD | OTHER | CTEP | View | |
| R01CA293394 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1CA189974 | NIH | None | https://reporter.nih.gov/quic… | View |