A Web-Based Dyadic Intervention for Colorectal Cancer

NCT05663203 | Recruiting DMC

• 3 other identifiers: STUDY00004750EU5733-222022RE03
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Attrition Rate

  Collect attendance records from each dyad before and after modules. The intervention will be considered to be high attrition if \> 80% dyads remain enrolled. Feasibility of study participation will be assessed by calculating retention rates, identifying reasons for refusal and assessing completeness of the data.

  Up to week 8

• Adherence Rate

  It is determined by high adherence if dyads complete \> 80% of the intervention protocol

  Up to week 8

• Acceptability Rate

  A survey will be created for this study to assess participants' perceptions of acceptability of the study procedures (\> 80% of participants reporting intervention is considered as high acceptability). Participants' perceptions of acceptability of the study procedures and of the intervention itself will be evaluated by calculating descriptive statistics to summarize responses to the post-intervention surveys as well as post-intervention interviews using content analysis.

  Up to week 8

• Multidimensional Fatigue Inventory

  Fatigue will be measured using the Multidimensional Fatigue Inventory (MFI). The MFI is a 20-item self-reported instrument that includes five dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension includes four items on a 1-5 scale. The total score, ranging from 20 to 100 (higher scores indicating more severe fatigue) is calculated as the sum of the five dimensions. The MFI has well established validity and reliability.

  Up to week 8

• Patient Health Questionnaire

  Depression will be measured using the eight-item Patient Health Questionnaire (PHQ-8), a well-established valid and reliable self-administered diagnostic measure for depressive disorders in clinical studies. The PHQ-8 asks the number of days in the past 2 weeks the respondent has experienced a variety of depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day); the sum of each item is the total score (0 to 24). Patients with a cutoff score of more than 10, clinically significant depression, will be referred to a clinical psychiatrist for further assistance.

  Up to week 8

• Pittsburgh Sleep Quality Index

  Sleep disturbance will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Its validity and reliability have been established in various populations, including patients with cancer. The PSQI consists of 19 items assessing sleep disturbances in seven dimensions (i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each dimension scores from 0 (no difficulty) to 3 (severe difficulty), and the sum of these dimension scores is the global sleep quality (0 to 21). Higher scores indicate more difficulty in sleeping.

  Up to week 8

• Brief Pain Inventory

  Pain will be assessed by the Brief Pain Inventory (BPI). Participants will rate the intensity of the pain (i.e., now, average, worst) using 0 (none) to 10 (excruciating) numeric rating scales (NRS). In addition, they will provide information on the length of time they are in pain, how often their pain occurs, locations of their pain, quality of the pain, pain's level of interference with function, and their level of pain relief and satisfaction with pain treatment.

  Up to week 8

• Attentional Function Index

  Attentional Function Index (AFI) consists of 16 items designed to measure cognitive dysfunction. A higher total mean score on a 0 to 10 NRS indicates a greater capacity to direct attention. Total scores are grouped into categories of attentional function (i.e., \<5.0 low function, 5.0 to 7.5 moderate function, \>7.5 high function). In addition, the AFI has three subscales (i.e., effective action, attentional lapses, and interpersonal effectiveness). The AFI has well established reliability and validity.)

  Up to week 8

Secondary Outcomes (1)

• Short Form Health Survey

  Up to week 8

Study Arms (1)

Supportive care (CRCWeb intervention)

EXPERIMENTAL

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

Other: Internet-Based Intervention; Other: Interview; Other: Survey Administration; Other: Electronic Health Record Review

Interventions

Internet-Based Intervention OTHER

Attend CRCWeb intervention

Supportive care (CRCWeb intervention)

Interview OTHER

Complete interview

Supportive care (CRCWeb intervention)

Survey Administration OTHER

Complete survey

Supportive care (CRCWeb intervention)

Electronic Health Record Review OTHER

Medical records are reviewed

Supportive care (CRCWeb intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients:
• Karnofsky Performance Scale \< 50
• Caregivers:
• Have severe diseases (e.g., cancer, heart disease)

Sponsors & Collaborators

• Emory University: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37379055 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yufen Lin, PhD, RN

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yufen Lin, PhD, RN

CONTACT

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

Canhua Xiao, PhD, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)