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

Primary

• 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.

  Time frame: Up to week 8

• Adherence Rate

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

  Time frame: 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.

  Time frame: 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.

  Time frame: 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.

  Time frame: 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.

  Time frame: 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.

  Time frame: 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.)

  Time frame: Up to week 8