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A Web-Based Dyadic Intervention for Colorectal Cancer
NCT05663203 · Emory University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers
About this study
PRIMARY OBJECTIVES:
I. To develop a web-based dyadic intervention for patients with colorectal cancer receiving chemotherapy and their caregivers (CRCweb).
Ia. Determine tailored contents by identifying needs and supports for a web-based dyadic intervention using interviews with patient-caregiver dyads (n=8); Ib. Develop a prototype of a web-based dyadic intervention program (CRCweb); Ic. Test the usability (e.g., design, navigation, structure, language) of CRCweb prototype using interviews with 4 dyads (in Aim Ia).
II. Evaluate the feasibility and acceptability of CRCweb for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.
III. Evaluate the preliminary effects of CRCweb on the primary outcome (i.e., attrition, adherence, acceptability, fatigue, depression, sleep disturbance, pain, and cognitive dysfunction) and secondary outcomes (i.e., quality of life) for patients with colorectal cancer receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.
OUTLINE:
Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.
Eligibility criteria
INCLUSION CRITERIA
Patients:
* Age \>= 18 years
* Diagnosed with colorectal cancer
* Life expectancy \> 12 months
* Receiving active chemotherapy
* Self-reported at least two psychoneurological symptoms (based on the symptom measures' cutoff scores)
* Identified primary caregiver (i.e., family members or significant others identified by the patients as their primary source of emotional and physical support)
* Access to the Internet
* Fluent in English
Caregivers:
* Age \>= 18 years
* Primary caregiver
* Access to the Internet
* Fluent in English
EXCLUSION CRITERIA
Patients:
• Karnofsky Performance Scale \< 50
Caregivers:
• Have severe diseases (e.g., cancer, heart disease)
Study design
Enrollment target: 56 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-05-01
Estimated completion: 2027-10-01
Last updated: 2025-12-19
Interventions
Other: Internet-Based InterventionOther: InterviewOther: Survey AdministrationOther: Electronic Health Record Review
Primary outcomes
- • Attrition Rate (Up to week 8)
- • Adherence Rate (Up to week 8)
- • Acceptability Rate (Up to week 8)
Sponsor
Emory University · other
With: Oncology Nursing Society
Contacts & investigators
ContactYufen Lin, PhD, RN · contact · yufen.lin@emory.edu · 404-712-9823
ContactCanhua Xiao, PhD, RN · contact · canhua.xiao@emory.edu · 404-712-9823
InvestigatorYufen Lin, PhD, RN · principal_investigator, Emory University Hospital/Winship Cancer Institute
All locations (1)
Emory University/Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States