Web-Based Support for Colorectal Cancer Patients and Caregivers
This study is testing a web-based program called CRCWeb to help patients with colorectal cancer and their caregivers manage difficult symptoms like fatigue, depression, and pain. Many patients receiving chemotherapy for colorectal cancer (cancer of the colon or rectum) experience these symptoms, which can affect their quality of life and that of their caregivers. The study aims to see if CRCWeb is easy to use and helpful. You might be able to join if you are an adult with colorectal cancer, have a life expectancy of over 12 months, are receiving chemotherapy, have at least two psychoneurological symptoms, and have an identified primary caregiver. The study will measure how many people use the program, how often they use it, and how much they like it. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 56 participants. It is testing a web-based program.
- What's involved
- You and your caregiver would attend the CRCWeb intervention over 8 weeks. You would also complete interviews and surveys throughout the trial.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, such as attrition, adherence, and acceptability, are measured up to week 8.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Web-Based Dyadic Intervention for Colorectal Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Yufen Lin, PhD, RN · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Attrition RateUp to week 8
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.
- Adherence RateUp to week 8
It is determined by high adherence if dyads complete \> 80% of the intervention protocol
- Acceptability RateUp to week 8
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.
- Multidimensional Fatigue InventoryUp to week 8
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.
- Patient Health QuestionnaireUp to week 8
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.
- Pittsburgh Sleep Quality IndexUp to week 8
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.
- Brief Pain InventoryUp to week 8
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.
- Attentional Function IndexUp to week 8
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.)