Recruiting

Dyadic Intervention

Sponsor:

Emory University

Code:

NCT05663203

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Internet-Based Intervention

Interview

Survey Administration

Electronic Health Record Review

Study Details

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.

Conditions

Colorectal Carcinoma

Study ID

NCT05663203

Start date

May 1, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (CRCWeb intervention)

Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.

Interventions

Internet-Based Intervention

Attend CRCWeb intervention

Interview

Complete interview

Survey Administration

Complete survey

Electronic Health Record Review

Medical records are reviewed

Primary outcome measure

  • Attrition Rate [ Time Frame: Up to week 8 ]
  • Adherence Rate [ Time Frame: Up to week 8 ]
  • Acceptability Rate [ Time Frame: Up to week 8 ]
  • Multidimensional Fatigue Inventory [ Time Frame: Up to week 8 ]
  • Patient Health Questionnaire [ Time Frame: Up to week 8 ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Up to week 8 ]
  • Brief Pain Inventory [ Time Frame: Up to week 8 ]
  • Attentional Function Index [ Time Frame: Up to week 8 ]

Central Contacts and Locations

Central contacts

Yufen Lin, PhD, RN

404-712-9823yufen.lin@emory.edu

Canhua Xiao, PhD, RN

404-712-9823canhua.xiao@emory.edu

Locations

Emory University/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Yufen Lin, PhD, RN

404-712-9823yufen.lin@emory.edu

More Information

Sponsor

Emory University

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-19.