Comprehension of Randomization and Uncertainty in Cancer Clinical Trials Decision Making Among Rural, Appalachian Patients

Abstract

Objective Comprehension of randomization is a vital, but understudied, component of informed consent to participate in cancer randomized clinical trials (RCTs). This study examines patient comprehension of the randomization process as well as sources of ongoing uncertainty that may inhibit a patient's ability to provide informed consent to participate in RCTs. Methods Cancer patients living in rural Appalachia who were offered an opportunity to participate in cancer treatment RCT completed in-depth interviews and a brief survey. Results No systematic differences in randomization comprehension between patients who consented and those who declined participation in a cancer RCT were detected. Comprehension is conceptually distinct from uncertainty, with patients who had both high and low comprehension experiencing randomization-related uncertainty. Uncertainty about randomization was found to have cognitive and affective dimensions. Conclusion Not all patients enrolling in RCTs have sufficient understanding of the randomization process to provide informed consent. Healthcare providers need to be aware of the different types of randomization-related uncertainty. Efforts to improve informed consent to participate in RCTs should focus on having patients “teach back” their understanding of randomization. This practice could yield valuable information about the patient's cognitive and affective understanding of randomization as well as opportunities to correct misperceptions. Education about RCTs should reflect patient expectations of individualized care by explaining how all treatments being compared are appropriate to the specifics of a patient's disease.

Evaluation of a Clinical Cancer Trial Research Training Workshop: Helping Nurses Build Capacity in Southwest Virginia

“…Krieger et al. () also noted uncertainty to Appalachian residents participation in trials related to concerns and emotions about randomization which underscores the need for comprehensive communication strategies for this cohort. Eliminating existing barriers to CCT for these populations is critical to improving morbidity and mortality statistics in this area as well as increasing the accrual of a wider pool of participants.…”

“…Individuals from rural communities are also underrepresented in CCTs (Ford et al, 2008;Krieger et al, 2015). Residents of rural areas and their health care needs differ from those in urban communities; those needs are not a simple "one size fits all approach" (Kenny et al, 2013).…”

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision

“…For situations in which investigators want further assurance that information can be brought to mind by participants without the external prompt provided by closed-ended question formats, open-ended methods such as teach-back are useful, although more time is required. These methods have been employed to assess comprehension among a variety of populations considered vulnerable to inadequate informed consent (Festinger et al, 2010; Krieger et al, 2015; Kripalani, Bengtzen, Henderson & Jacobson, 2008). …”

Evaluating the effectiveness and cost-effectiveness of British Sign Language Improving Access to Psychological Therapies: an exploratory study

“…In part this response may be attributed to participants perceiving that random allocation gives them a chance of treatment that they believe is superior to the alternative, and that they would not otherwise have been able to access. 48 With respect to Deaf people, perceived treatment preferences that may influence the acceptability of randomisation are likely to be fundamentally connected with language and culture. It is well evidenced that Deaf people experience significant health inequalities in terms of access to services and health outcomes in a range of domains.…”