Colon cancer, the third most common type of cancer, affects over 106,680 persons in the United States (U.S.) with two-thirds of persons diagnosed at the advanced stage of disease requiring chemotherapy treatment. Chemotherapy-induced diarrhea (CID) is the leading symptom management problem associated with dose-limiting toxicity, life-threatening conditions, and impaired quality of life outcomes. Consensus panels report that assessment is problematic due to lack of a standardized symptom instrument for early recognition and prompt management of CID. An instrument that measures specific and comprehensive CID symptoms, including intensity/frequency, severity and distress, for colon cancer patients during chemotherapy treatment is needed. The purpose of this revised study proposal is to develop a comprehensive CID symptom instrument (CID-C) for colon cancer patients. The revised specific aims include Aim 1 to develop a minimum of 50-75 CID-C items, organized by the three domains of the CID-C framework based on: a) draft of CID-C instrument items constructed from review of literature findings and current diarrhea /cancer/ treatment related tools with study consultants; and b) qualitative descriptive interviews with 10 colon cancer patients for contextual relevance.
Aim 2 is to evaluate items by conducting Think Aloud interviews with a minimum of 10 colon cancer patients with CID for cognitive pre-testing; content validity assessment of each item and the instrument as a whole with an expert and experiential panel; and, a grade level assessment of each item.
Aim 3 is to review items for inclusion, revision, or deletion.
Aim 4 is to conduct a pilot test of the CID-C Instrument with 10-12 colon cancer patients experiencing CID. Data analysis will include content analysis of qualitative interviews using NVivo v.2 and Think Aloud interviews, content validity index scoring of items, content analysis of issues encountered during pilot testing, and descriptive statistics of demographic data using SPSS v. 14. The proposed study is essential in developing a CID instrument for use in future research studies to describe the experience and target psychoeducational and/or behavioral interventions for symptom prevention and management. ? ? ?
