Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret

OBJECTIVE: To understand the psychosocial outcomes related to decision-making processes of individuals eligible for participation in clinical trials. METHODS: Individuals eligible to participate in selected clinical trials were contacted to complete two surveys; one shortly after participants were identified, and the second 6 weeks after the first survey was completed (N=50). Measures included subjective informed consent; satisfaction with decision-making; decisional regret; and timing of consent (early versus late signers). ANOVA and correlation coefficients were used to test the relationships between variables. RESULTS: Early signers reported themselves to be less informed about the details of their particular clinical trials than later signers (M=81.9 versus 91.2; F=5.5; p=.02). There was a non-significant trend for early signers to be less satisfied with their decisions than late signers. Satisfaction with decision-making and subjective informed consent were both strongly associated with later decisional regret (r=-.32 and -.30, respectively). However, there was no relationship between timing of consent and decisional regret. CONCLUSION: Participants who enroll in clinical trials quickly may not believe they fully understand the implications of trial participation. In general, participants who do not believe they fully understand the implications of trial participation, or who are less satisfied with their decision to enroll in the trial may ultimately feel regret about their decision to participate. PRACTICE IMPLICATIONS: More effort is needed to ensure that clinical trial participants fully understand the risks and benefits of participation and are satisfied with their decision to enroll in a trial prior to signing consent forms.     

Individual versus group therapy for obesity: effects of matching participants to their treatment preferences

This study examined the effects of matching participants to treatments on the basis of their preferences for either individual or group therapy for obesity. Seventy-five obese adults who expressed a clear preference for either individual or group therapy were randomly assigned to either their preferred or their nonpreferred treatment modality within a 2 (individual vs. group therapy) x 2 (preferred vs. nonpreferred modality) factorial design. At posttreatment, group therapy produced significantly greater reductions in weight and body mass than individual therapy, and no significant effects were observed for treatment preference or the interaction for treatment preference by type of therapy. All treatment conditions showed equivalent improvements in psychological functioning. These findings suggest that group therapy produces greater weight loss than individual therapy, even among those clients who express a preference for individual treatment.     

The who,what, and why of research participants’ intentions to request a broad range of secondary findings in a diagnostic genomic sequencing study

PurposeIn a diagnostic exome sequencing study (the North Carolina Clinical Genomic Evaluation by Next-Generation Exome Sequencing project, NCGENES), we investigated adult patients’ intentions to request six categories of secondary findings (SFs) with low or no medical actionability and correlates of their intentions.MethodsAt enrollment, eligible participants (n = 152) completed measures assessing their sociodemographic, clinical, and literacy-related characteristics. Prior to and during an in-person diagnostic result disclosure visit, they received education about categories of SFs they could request. Immediately after receiving education at the visit, participants completed measures of intention to learn SFs, interest in each category, and anticipated regret for learning and not learning each category.ResultsSeventy-eight percent of participants intended to learn at least some SFs. Logistic regressions examined their intention to learn any or all of these findings (versus none) and interest in each of the six individual categories (yes/no). Results revealed little association between intentions and sociodemographic, clinical, or literacy-related factors. Across outcomes, participants who anticipated regret for learning SFs reported weaker intention to learn them (odds ratios (ORs) from 0.47 to 0.71), and participants who anticipated regret for not learning these findings reported stronger intention to learn them (OR 1.61–2.22).ConclusionIntentions to request SFs with low or no medical actionability may be strongly influenced by participants’ desire to avoid regret.     

Satisfaction with treatment decision-making and treatment regret among Latinas and non-Latina whites with DCIS

Objective

To examine differences in treatment decision-making participation, satisfaction, and regret among Latinas and non-Latina whites with DCIS.

Methods

Survey of Latina and non-Latina white women diagnosed with DCIS. We assessed women's preferences for involvement in decision-making, primary treatment decision maker, and participatory decision-making. We examined primary outcomes of satisfaction with treatment decision-making and treatment regret by ethnic-language group.

Results

Among 745 participants (349 Latinas, 396 white) Spanish-speaking Latinas (SSL) had the highest mean preference for involvement in decision-making score and the lowest mean participatory decision-making score and were more likely to defer their final treatment decision to their physicians than English-speaking Latinas or whites (26%, 13%, 18%, p < 0.05). SSLs reported lower satisfaction with treatment decision-making (OR 0.4; CI 95%, 0.2–0.8) and expressed more regret than whites (OR 6.2; CI 95%, 3.0–12.4). More participatory decision-making increased the odds of satisfaction (OR 1.5; CI 95%, 1.3–1.8) and decreased the odds of treatment regret (OR 0.8; CI 95%, 0.7–1.0), independent of ethnicity-language.

Conclusion

Language barriers impede the establishment of decision-making partnerships between Latinas and their physicians, and result in less satisfaction with the decision-making process and more treatment regret.

Practice implications

Use of professional interpreters may address communication-related disparities for these women.     

Modeling patient-centered communication: Oncologist relational communication and patient communication involvement in breast cancer adjuvant therapy decision-making

Objective

Relational communication refers to those messages communicators naturally express that carry meaning about the type and quality of relationship they share. It is expected that patients of oncologists who express positive relational communication will be more communicatively involved in their office visits, and regret their decision for adjuvant therapy following surgery less.

Methods

One hundred eighty (180) audio-recorded discussions between oncologists (n = 40) and early stage (I–III) breast cancer patients were coded with the Siminoff Communication Content and Affect Program (SCCAP). The data were used to test the relationships between patient demographics, oncologist relational communication, patient communication involvement and self-reported patient decision regret.

Results

After controlling for clinician clusters, oncologists’ verbal (i.e., confirming messages) and nonverbal (i.e., direct and inclusive speech) relational communication is indirectly associated with lower patient decision regret via the mediating effect of greater patient communication involvement.

Conclusion

Clinician relational communication provides an influential affective climate for decision-making that appears to have important effects on patients’ decision confidence.

Practice implications

Clinicians should recognize the potential of their own relational messages to facilitate patients’ communication involvement in decision-making during cancer care.     

The neural consequences of flip-flopping: The feedback-related negativity and salience of reward prediction

Research suggests that the feedback-related negativity (FRN) is only sensitive to expectancy when the prediction violation is salient. To further examine this issue, we asked participants to guess which of two virtual doors hid 5 cents. Prior to and after making their guess, participants were asked whether or not they expected to win. We extracted four conditions based on subjects' predictions before and after their choice of door: (1) win/win, (2) lose/lose, (3) win/lose, and (4) lose/win. Results revealed that the FRN was largest on trials in which subjects predicted they were not going to win and then changed their minds and predicted that they were going to win (i.e., the lose/win condition). Together with previous FRN results and findings in the area of regret and decision making, we suggest that the FRN reflects a context-sensitive signal that integrates information about current and past actions, thoughts, and emotions.     

Attitudes of couples identified through screening as carriers of Gaucher disease type 1

Gaucher disease (GD) type 1 is the most frequent autosomal recessive disorder among Ashkenazi Jews, but because the phenotype is tremendously variable, including it in the 'Ashkenazi Panel' of carrier screening is controversial. As part of a nationwide study conducted in Israel to evaluate the outcomes of carrier screening for GD, we studied the experience of 65/82 (79%) of the couples identified as being at risk for an affected child. We found that pre-test information was regarded as insufficient and improved in post-result counseling. About 70% of the subjects interpreted the genetic counseling as directive, mostly toward prenatal diagnosis (PND) but against pregnancy termination of affected fetuses. We evaluated the various motivations that had led couples to utilize PND. Subjects' attitudes toward pregnancy termination correlated with their specific genotypes, with their perception of the severity of GD and with attending additional medical consultation. Of the 30 interviewed participants who were faced with having an affected fetus, 80% came to terms with their decision to utilize PND, but about half of the few who terminated the pregnancy regret their decision. Despite questionable benefits of screening, most of the participants did not regret having been tested and supported the continuation of this program. We offer explanations for these findings and suggest extensive genetic and medical counseling for any future carrier screening for low penetrance, treatable disease.     

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial

Objective

To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund.

Methods

Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence.

Results

Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001).

Conclusion

PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account.

Practice implications

This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.     

Returning negative results to individuals in a genomic screening program: lessons learned

PurposeIn genomics, the return of negative screening results for rare, medically actionable conditions in large unselected populations with low prior risk of disease is novel and may involve important and nuanced concerns for communicating their meaning. Recruitment may result in self-selection because of participants’ personal or family history, changing the characteristics of the screened population and interpretation of both positive and negative findings; prior motivations may also affect responses to results.MethodsUsing data from GeneScreen, an exploratory adult screening project that targets 17 genes related to 11 medically actionable conditions, we address four questions: (1) Do participants self-select based on actual or perceived risk for one of the conditions? (2) Do participants understand negative results? (3) What are their psychosocial responses? (4) Are negative results related to changes in reported health-related behaviors?ResultsWe found disproportionate enrollment of individuals at elevated prior risk for conditions being screened, and a need to improve communication about the nature of screening and meaning of negative screening results. Participants expressed no decision regret and did not report intention to change health-related behaviors.ConclusionThis study illuminates critical challenges to overcome if genomic screening is to benefit the general population.     

Change in feelings of regret over time: relation to decision-making style, behavior, and coping methods

This study investigated the change in feelings of regret over time in relation to decision-making style, critical thinking, behavior, and coping methods with the regret. Seventy undergraduate students completed a questionnaire on critical thinking, decision-making styles, feelings of regret and the coping methods in five different situations: entrance examinations, declarations of love, skiing, career changes, and investments. Results showed the following. First, in situations which normally occur only once (i.e., entrance examinations), subjects who indicated inaction felt increased regret over time, but those who indicated action felt decreased regret. Conversely, in situations which occur regularly (i.e., declarations of love and skiing), both of those who indicated action and inaction felt decreased regret. Second, people who indicated action coped with their regret using the method of rationalization more often than those who indicated inaction. In situations which normally occur only once, analytic decision-makers tended to cope with their regret by improving their behavior more than intuitive decision-makers. Finally, critical thinkers tended to adopt an analytic style more often than an intuitive style.     

Using decision aids in community-based primary care: A theory-driven evaluation with ethnically diverse patients

ObjectiveTo assess the effects of informational brochures and video decision aids about cancer screening on patient intention to engage in shared decision-making and its predictors in a racially diverse sample.MethodsParticipants were recruited from 13 community-based primary care practices serving racially and ethnically diverse patients in predominately economically disadvantaged neighborhoods. Participants completed theory-based measures assessing attitudes, perceived social norms, self-efficacy and intentions for working with their physician to make a cancer screening decision after reviewing a brochure or video decision aid, but before seeing the physician. A post-questionnaire assessed screening decisions and participant knowledge.ResultsParticipants who reviewed a video decision aid had higher knowledge and were more likely to want to be the primary decision-maker. They reported lower perceived social norms, self-efficacy and intentions to work with their physicians than participants who reviewed a brochure. Participants who decided against cancer screening reported lower intentions to work with their physician in making a decision and were less likely to report having spoken with their physician about screening.ConclusionParticipants who opted against cancer screening after reviewing a brochure or decision aid were less likely to discuss their decision with their physician. The tendency toward autonomous decision-making was stronger among participants who reviewed a video decision aid.     

Using decision aids in community-based primary care: a theory-driven evaluation with ethnically diverse patients

Objective

To assess the effects of informational brochures and video decision aids about cancer screening on patient intention to engage in shared decision-making and its predictors in a racially diverse sample.

Methods

Participants were recruited from 13 community-based primary care practices serving racially and ethnically diverse patients in predominately economically disadvantaged neighborhoods. Participants completed theory-based measures assessing attitudes, perceived social norms, self-efficacy and intentions for working with their physician to make a cancer screening decision after reviewing a brochure or video decision aid, but before seeing the physician. A post-questionnaire assessed screening decisions and participant knowledge.

Results

Participants who reviewed a video decision aid had higher knowledge and were more likely to want to be the primary decision-maker. They reported lower perceived social norms, self-efficacy and intentions to work with their physicians than participants who reviewed a brochure. Participants who decided against cancer screening reported lower intentions to work with their physician in making a decision and were less likely to report having spoken with their physician about screening.

Conclusion

Participants who opted against cancer screening after reviewing a brochure or decision aid were less likely to discuss their decision with their physician. The tendency toward autonomous decision-making was stronger among participants who reviewed a video decision aid.     

Participant experiences of genome sequencing for rare diseases in the 100,000 Genomes Project: a mixed methods study

In this mixed methods study, a survey and in-depth interviews were used to explore whether decision regret and the psychological impact of receiving genome sequencing (GS) results differed between parents and patients, and between those who received a genetic diagnosis and those who did not. Participants (n = 77) completed a survey that included the Decisional Regret Scale (DRS) and an adaptation of the Multidimensional Impact of Cancer Risk Assessment (MICRA) at least 12 months after consenting for GS for rare disease diagnosis in the 100,000 Genomes Project. Survey participants were invited to take part in an interview and 39 agreed; 12 with a diagnosis, 5 with variants of uncertain significance, and 19 with no pathogenic findings identified. Both survey and interview findings indicated that decision regret was low. DRS scores revealed no differences in levels of regret between parents and patients, or between those with a diagnosis and those without. Though MICRA scores indicated minimal evidence of negative psychological impacts of receiving GS results, subscale analysis revealed greater distress and uncertainty for parents compared to patients. Receiving a diagnosis was found not to influence MICRA scores, supporting interview findings of both positive and negative emotional and psychological impacts irrespective of a genetic diagnosis. Our findings have implications for policy and practice as GS is integrated into the UK and worldwide; notably, that expectation-setting is critical when offering GS, and that post-test counselling is important regardless of the GS result received, with parents perhaps needing additional emotional support.Subject terms: Social sciences, Genomics     

Pilot Randomized Controlled Trial of LEAP: A Selective Preventive Intervention to Reduce Adolescents’ Perceived Burdensomeness

This research draws upon the interpersonal-psychological theory of suicide in the development of the LEAP intervention, a web-based selective preventive suicide intervention targeting cognitions of perceived burdensomeness toward others. The pilot randomized controlled trial consisted of 80 adolescents (68.8% female, 65.8% Hispanic) 13–19 of age years who were randomly assigned to either the LEAP intervention or a psychoeducational control condition. Participants completed baseline, posttreatment, and 6-week follow-up assessments. All participants reported high levels of satisfaction with the program. Findings on outcome variables differed across intent-to-treat analyses and treatment completer analyses. Intent-to-treat analysis yielded no significant between-condition differences in perceived burdensomeness at posttreatment or follow-up. Treatment completer analyses revealed significant between-condition differences on outcome variables such that participants who completed the LEAP intervention showed significantly lower perceived burdensomeness scores at postintervention and significantly lower perceived burdensomeness, thwarted belongingness, and depressive symptom scores at follow-up as compared to participants in the control condition. No significant differences in suicidal ideation were found between conditions. These findings support the promise of the LEAP intervention as a brief, web-based selective preventive intervention for reducing perceived burdensomeness among adolescents who complete the intervention. This study provides evidence that perceived burdensomeness can be modified via a psychosocial intervention. Future research is needed to identify ways to enhance adolescent engagement with and completion of the intervention.     

Imagining others’ handedness: visual and motor processes in the attribution of the dominant hand to an imagined agent

In a previous study, we found that when required to imagine another person performing an action, participants reported a higher correspondence between their own dominant hand and the hand used by the imagined person when the agent was visualized from the back compared to when the agent was visualized from the front. This suggests a greater involvement of motor representations in the back-view perspective, possibly indicating a greater proneness to put oneself in the agent’s shoes in such a condition. In order to assess whether bringing to the foreground the right or left hand of an imagined agent can foster the activation of the corresponding motor representations, we required 384 participants to imagine a person—as seen from the right or left side—performing a single manual action and to indicate the hand used by the imagined person during movement execution. The proportion of right- versus left-handed reported actions was higher in the right-view condition than in the left-view condition, suggesting that a lateral vantage point may activate the corresponding hand motor representations, which is in line with previous research indicating a link between the hemispheric specialization of one’s own body and the visual representation of others’ bodies. Moreover, in agreement with research on hand laterality judgments, the effect of vantage point was stronger for left-handers (who reported a higher proportion of right- than left-handed actions in the right-view condition and a slightly higher proportion of left- than right-handed actions in the left-view condition) than for right-handers (who reported a higher proportion of right- than left-handed actions in both view conditions), indicating that during the mental simulation of others’ actions, right-handers rely on sensorimotor processes more than left-handers, while left-handers rely on visual processes more than right-handers.     

The use of subjective experience in the prediction of others' behavior

The present research investigated the role of experienced ease of retrieval in predicting future behavior of others. People retrieve past examples of others' behavior to predict how they would behave in the future. But well-defined, high trait evaluations about others decrease the informational value of the retrieved content. In this case, people may base their predictions on the ease or difficulty which they experienced during the retrieval of examples. In two experiments, participants were asked to think of an acquaintance who they evaluated as being assertive or less assertive. The trait evaluations were manipulated by using different experimental instructions (Experiment 1) or using measured trait evaluation scores (Experiment 2). Then, participants retrieved one (easy) or four (difficult) past examples of the acquaintance's behavior. In the case of an assertive acquaintance, participants predicted a higher likelihood of assertive behaviors after retrieving one example than after retrieving four examples, whereas in the case of a less assertive acquaintance the reverse was true. These results suggest that subjective experiences can have informational value even when making predictions of others' future behavior.     

BRCA1/2 testing in hereditary breast and ovarian cancer families II: impact on relationships

Members of hereditary breast and ovarian cancer (HBOC) families often express concern during genetic counseling about the impact of BRCA1/2 testing on close relatives. Yet whether there are likely to be adverse effects of either the decision to undergo genetic testing or the results of testing on family relationships is unknown. One purpose of this study was to assess the impact on close family relationships. Within a randomized trial of breast cancer genetic counseling methods, members of 13 HBOC families were offered BRCA1/2 testing for a known family mutation. The Family Relationship Index (FRI) of the Family Environment Scale (FES) was used to measure perceived family cohesion, conflict, and expressiveness at baseline and again 6-9 months following the receipt of test results, or at the equivalent time for those who declined testing. Participants (n = 212) completed baseline and follow-up questionnaires. Comparisons were made between testers and non-testers as well as between those who tested positive and negative for the family mutation. One hundred eighty-one participants elected to undergo genetic testing (85%) and 47 (26%) were identified to have a mutation. After adjusting for baseline family relationship scores, counseling intervention, gender and marital status, non-testers reported a greater increase in expressiveness (P = 0.006) and cohesion (P = 0.04) than testers. Individuals who tested positive reported a decrease in expressiveness (P = 0.07), although as a trend. Regardless of test decision or test result, those who were randomized to a client-centered counseling intervention reported a decrease in conflict (P = 0.006). Overall, study results suggest that undergoing genetic testing and learning ones BRCA1/2 status may affect family relationships. Those individuals who declined testing reported feeling closer to family members and more encouraged to express emotions to other family members demonstrating potential benefit from the offer of testing. Since those who tested positive reported feeling less encouraged to express their emotions within the family, we recommend helping clients to identify others with whom they feel comfortable sharing their thoughts and feelings about their positive gene status and increased cancer risk.     

Parents’ attitudes towards and perceptions of involving minors in medical research from the Japanese perspective

Background

Children’s intentions should be respected. Parents are the key persons involved in decision-making related to their children. In Japan, the appropriate ages and standards for a child’s consent and assent, approval, and decision-making are not clearly defined, which makes the process of obtaining consent and assent for clinical research complex. The purpose of this paper is as follows: to understand the attitudes and motives of parents concerning children’s participation in medical research and the factors influencing their decision-making. We also sought to clarify who has the right to be involved in decisions regarding children’s participation in research.

Methods

A semi-structured Internet survey on parents’ opinions and attitudes and preferences concerning medical research involvement was conducted. Children were divided into three age groups (6–10-year-olds, 11–14-year-olds, and 15–18-year-olds), with three illness severity categories. Possible correlations between the number of children, children’s ages, parents’ educational levels, and parents’ attitudes were examined.

Results

Among the participants, 42.3% recognized the term “informed consent.” The proportion of participants who understood “informed consent” increased with educational level. Four out of five participants did not know, or had not heard of, the term “informed assent.” Furthermore, the percentage of those who understood the term “informed assent” increased with academic level. Participants generally believed in prioritizing parents’ opinions over children’s, and that parents and children would ideally reach a joint decision. Although many parents favored collaborative decision-making, they also wanted their own will reflected in the decision and felt they should receive important information before their children do. Decision-making was affected by the condition’s severity and prognosis. This indicates that most Japanese parents believe that their children have the right to know their disease name and treatment; nonetheless, they should be protected. Parents’ values and judgments regarding medical intervention involving their children varied.

Conclusions

Children’s ability to consent to treatment and research believed to be in their best interests should be assessed appropriately. They should be permitted to provide consent or assent, and their views should be respected. Involving children in decision-making fosters more open communication and transparency between medical professionals, parents, and children.