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Recruiting NCT05663203

A Web-Based Dyadic Intervention for Colorectal Cancer

No phase Interventional Colorectal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Intervention, Interview, Survey Administration, Electronic Health Record Review.
Who it may be relevant to
Registry conditions: Colorectal Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers

Overview

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.

Interventions

  • Other Internet-Based Intervention
    Attend CRCWeb intervention
  • Other Interview
    Complete interview
  • Other Survey Administration
    Complete survey
  • Other Electronic Health Record Review
    Medical records are reviewed

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Short Form Health Survey [Time frame: Up to week 8]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Emory University/Winship Cancer Institute — Atlanta

Publications

  • 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

Identifiers

NCT: NCT05663203 · STUDY00004750 · EU5733-22 · 2022RE03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗