Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2023-05-01
2027-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (CRCWeb intervention)
Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.
Internet-Based Intervention
Attend CRCWeb intervention
Interview
Complete interview
Survey Administration
Complete survey
Electronic Health Record Review
Medical records are reviewed
Interventions
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Internet-Based Intervention
Attend CRCWeb intervention
Interview
Complete interview
Survey Administration
Complete survey
Electronic Health Record Review
Medical records are reviewed
Eligibility Criteria
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Inclusion Criteria
* 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
• Karnofsky Performance Scale \< 50
Caregivers:
• Have severe diseases (e.g., cancer, heart disease)
18 Years
ALL
Yes
Sponsors
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Oncology Nursing Society
OTHER
Emory University
OTHER
Responsible Party
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Yufen Lin
Principal Investigator
Principal Investigators
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Yufen Lin, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Yufen Lin, PhD, RN
Role: primary
References
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Lin Y, Porter LS, Chee W, Alese OB, Curseen KA, Higgins MK, Northouse L, Xiao C. A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2023 Jun 28;12:e48499. doi: 10.2196/48499.
Other Identifiers
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STUDY00004750
Identifier Type: -
Identifier Source: org_study_id
EU5733-22
Identifier Type: OTHER
Identifier Source: secondary_id
2022RE03
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id