Clinical trial NCT05663203: A Web-Based Dyadic Intervention for Colorectal Cancer
Official title: A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2022-12-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.

Detailed description: 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)

Primary outcomes:
measure: Attrition Rate
timeFrame: Up to week 8
measure: Adherence Rate
timeFrame: Up to week 8
measure: Acceptability Rate
timeFrame: Up to week 8
measure: Multidimensional Fatigue Inventory
timeFrame: Up to week 8
measure: Patient Health Questionnaire
timeFrame: Up to week 8
measure: Pittsburgh Sleep Quality Index
timeFrame: Up to week 8
measure: Brief Pain Inventory
timeFrame: Up to week 8
measure: Attentional Function Index
timeFrame: Up to week 8
Secondary outcomes:
measure: Short Form Health Survey
timeFrame: Up to week 8
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Yufen Lin, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: