Development and validation of a drug clinical trial participation feelings questionnaire for cancer patients

TL;DR

This paper introduces a new questionnaire to measure how cancer patients feel about participating in drug clinical trials.

Contribution

The study developed and validated a novel questionnaire called DCTPFQ to assess cancer patients' feelings about clinical trial participation.

Findings

The DCTPFQ consists of 21 items grouped into four factors: cognitive engagement, subjective experience, medical resources, and relatives and friends’ support.

The questionnaire showed strong reliability (test–retest reliability of 0.840 and Cronbach’s alpha of 0.934).

DCTPFQ is significantly correlated with existing psychological scales like the Fear of Progression Questionnaire and Mishel’s Uncertainty in Illness Scale.

Abstract

The study was designed to develop and validate a new drug clinical trial participation feelings questionnaire (DCTPFQ) for cancer patients.

Data collection and analysis involved a combination of qualitative and quantitative methods. There were two phases to this study. Phase Ⅰ involved developing a questionnaire to establish a list of items to be included in the pool: A theoretical framework was constructed based on the transitions theory and the Roper–Logan–Tierney theory. After incorporating a theoretical framework, interviewing participants, and reviewing the literature, 44 items were generated. After a Delphi consultation and a pilot test, 36 items proceeded to item analysis and exploratory factor analysis (EFA), and a four-factor structure with 21 items was formed. Confirmatory factor analysis (CFA), test–retest reliability, criteria-related validity, and internal consistency tests were conducted in phase II to examine the psychometric properties.

There were 21 items on the DCTPFQ, ranging from 1 (fully disagree) through 5 (fully agree). As a result of EFA and CFA, the four factors of DCTPFQ could be verified, including cognitive engagement, subjective experience, medical resources, and relatives and friends’ support. Test–retest reliability of the DCTPFQ was 0.840, and Cronbach’s alpha was 0.934. DCTPFQ is significantly correlated with the Fear of Progression Questionnaire—short form (r = 0.731, p < 0.05) and the Mishel’s Uncertainty in Illness Scale (r = 0.714, p < 0.05).

The DCTPFQ is a useful tool for measuring the drug clinical trial participation feelings among cancer patients.

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