Reasons given by patients for participating, or not, in Phase 1 cancer trials

Background

Communication with patients contemplating Phase 1 cancer trial participation can be challenging. Controversy exists as to whether they are provided with sufficient information to give genuinely informed consent. We present data examining the reasons patients gave for trial entry.

Method

Following discussions with oncologists about Phase1 trials, participants completed a 19-item study specific ‘accept or decline measure’ exploring hope, expectations of benefit, altruism, concerns, and general perceptions of the trial information. They also completed 2 standardised questionnaires measuring psychological morbidity and predisposition towards optimism.

Results

Forty patients completed the study questionnaires. Patients were generally optimistic with few concerns about the experimental nature of Phase 1 trials. Most 36/40 (90%) consented to trial entry. Fifty-one percent thought the trial was the only treatment option available. The four main reasons for trial entry were: expectation of some medical benefit (21%); trial the best available option (21%); to maintain hope (15%) and to help with research (13%). Only one patient gave altruism as their main reason for trial participation.

Conclusion

Patients considering Phase 1 trials may be a self-selected group with optimistic expectations of personal benefit driving trial entry rather than altruism. Achieving genuinely informed consent and avoidance of therapeutic misconceptions in such patients may be difficult.     

Troubled parents,motivated adolescents: Predicting motivation to change substance use among runaways

Runaway adolescents engage in high rates of substance use and report significant family and individual problems. However, in general, adolescents report low motivation to change their substance use. Because a higher level of motivation for changing substance use is associated with greater substance abuse treatment success, identifying variables associated with motivation for change can be useful for enhancing treatment success. In this study, predictors of motivation for changing substance use were examined among 140 shelter-recruited adolescents and their parents/primary caretakers. Several findings were noteworthy. A perceived negative family environment increased parents' and adolescents' depressive symptoms, which increased adolescent's motivation to change. Also, greater severity of adolescent substance use predicted higher motivation to change. Consideration of the family environment and parent problems when addressing motivation for changing substance use among these adolescents might be important foci for motivational interventions and future research.     

Motivation,money and respect: A mixed-method study of Tanzanian non-physician clinicians

Poor quality of care is a major concern in low-income countries, and is in part attributed to low motivation of healthcare workers. Non-physician clinicians (mid-level cadre healthworkers) are central to healthcare delivery in half of the countries in Africa, but while much is expected from these clinicians, little is known about their expectations and motivation to perform well. Understanding what motivates these healthworkers in their work is essential to provide an empirical base for policy decisions to improve quality of healthcare. In 2006–2007, we conducted a mixed-method study to evaluate factors affecting motivation, including reasons for varying levels of motivation, amongst these clinicians in Tanzania. Using a conceptual framework of ‘internal’ and ‘environmental’ domains known to influence healthworker motivation in low-income countries, developed from existing literature, we observed over 2000 hospital consultations, interviewed clinicians to evaluate job satisfaction and morale, then designed and implemented a survey instrument to measure work motivation in clinical settings. Thematic analysis (34 interviews, one focus group) identified social status expectations as fundamental to dissatisfaction with financial remuneration, working environments and relationships between different clinical cadres. The survey included all clinicians working in routine patient care at 13 hospitals in the area; 150 returned sufficiently complete data for psychometric analysis. In regression, higher salary was associated with ‘internal’ motivation; amongst higher earners, motivation was also associated with higher qualification and salary enhancements. Salary was thus a clear prerequisite for motivation. Our results are consistent with the hypothesis that non-salary motivators will only have an effect where salary requirements are satisfied. As well as improvements to organisational management, we put forward the case for the professionalisation of non-physician clinicians.     

Validation of the Unified Parkinson's Disease Rating Scale (UPDRS) section I as a screening and diagnostic instrument for apathy in patients with Parkinson's disease

We examined the validity of the motivation/initiative item of the Unified Parkinson's Disease Rating Scale (UPDRS) section I as a screening and diagnostic measure for apathy in Parkinson's disease (PD). Fifty-eight patients with PD were evaluated with the UPDRS, the 14-item Apathy Scale (AS), and standardized rating scales of depression and cognitive impairment. Apathy was diagnosed using specific items of the AS together with proposed criteria for apathy. A score of 2 or more on the motivation/initiative item was adequate to screen for apathy, whereas a score of 4 had high diagnostic accuracy at the cost of unacceptable low sensitivity.     

Increasing the incentive salience of cocaine challenges preference for pup- over cocaine-associated stimuli during early postpartum: place preference and locomotor analyses in the lactating female rat

Rationale/Objectives Prior studies using a dual-choice conditioned place preference (CPP) procedure revealed that postpartum female rats (dams) strongly prefer chambers associated with pups over those associated with subcutaneously administered cocaine almost exclusively during early but not late postpartum (Mattson et al. 2001). The present study examines whether early postpartum dams retain strong pup-associated chamber preference when contrasted with a cocaine stimulus of greater incentive salience (intraperitoneal [IP] injections with brief conditioning sessions). Locomotor rate was measured during conditioning (stimuli-present) and test (stimulus-absent) sessions. Materials and methods A three-chambered CPP apparatus was used to compare preferences for chambers associated with IP cocaine vs age-matched pups. Unconditioned stimuli were systematically assigned to the least-preferred chamber of separate groups of dams before conditioning. Control dams verified that unconditioned stimuli were necessary for CPP and stimulus-associated locomotion. Results Compared with most late postpartum dams (60%), only 31% of early postpartum dams preferred the cocaine-associated chamber (P < 0.05). Substantially more dams preferred the pup-associated chamber during early postpartum (27%) than late postpartum (5%; P < 0.05). Locomotor sensitization emerged across cocaine-conditioning sessions in cocaine-preferring but not pup-preferring dams (P < 0.05). Locomotor rates were consistently lower in preferred vs nonpreferred chambers during test. Conclusions After increasing cocaine’s incentive salience, more early postpartum dams prefer the cocaine-associated chamber than previously reported (Mattson et al. 2001). However, pup-associated chamber preference was still higher in early vs late postpartum. Pup- and cocaine-preferring dams expressed differences in the induction phase of locomotor sensitization across cocaine conditioning but expressed similar motoric patterns in their preferred chambers at test.     

Cognitive-motivational predictors of excessive drinkers’ success in changing

Aims The purpose of this study was to identify cognitive (alcohol attentional bias, AAB) and motivational (motivational structure, MS; readiness to change, RTC) predictors of changes in excessive drinking. Materials and methods One hundred fifty-eight excessive drinkers not in treatment were administered a test battery and were re-tested 3 and 6 months later. The tests included the alcohol timeline followback, readiness to change questionnaire, alcohol Stroop (to measure AAB), personal concerns inventory (to measure MS), and a measure of family history of alcohol problems (FHAP). Results High RTC predicted short-term but not long-term reductions in drinking; both low AAB and high FHAP predicted long-term reductions. MS interacted with both AAB and RTC so that the greatest long-term drinking reductions occurred among participants with adaptive MS and low AAB and among those with adaptive MS and high RTC. Conclusion It was concluded that (a) both cognitive and motivational factors affect the likelihood of drinking reductions and (b) a complete understanding of drinking problems should be formulated in terms of both cognitive and motivational variables.     

Brief motivational enhancement and coping skills interventions for heavy drinking

Two brief (3-session) interventions were evaluated in a community sample of 98 non-dependent heavy drinking adults. Three weeks of intensive daily monitoring of drinking using a hand-held computer were completed before and after a 3-week intervention phase in which participants were randomly assigned to a brief coping skills, brief motivational enhancement, or waiting list condition. Waiting list participants drank more before, during, and after the brief intervention than brief intervention subjects, but all participants demonstrated reductions in drinking amount and frequency. No differences in drinking were found between the two brief interventions. The potential value of intensive daily monitoring as a tool for non-alcohol dependent individuals interested in reducing their drinking was considered.     

Readiness to change smoking behavior in adolescents with psychiatric disorders

There has been recent increased interest in utilizing motivational interviewing (MI) to increase adolescent readiness to quit smoking, but attempts to impact quit rates have thus far been discouraging. A better understanding of factors associated with adolescent readiness to quit smoking prior to receiving any intervention may provide guidance when tailoring future MI interventions in order to increase their effectiveness with this population. Adolescent smokers (N=191) who had been admitted to a psychiatric hospital and enrolled in a clinical trial evaluating MI completed questionnaires that assessed smoking behavior and variables thought to be related to smoking. Confidence to quit smoking and negative beliefs about smoking were significant predictors of adolescents' baseline readiness to quit smoking. The failure to demonstrate relationships between health consequences and readiness suggest that caution may be warranted in the use of feedback, a common component of MI-based interventions. Such feedback tends to focus on health consequences, which was unrelated to adolescent baseline readiness to change smoking behavior in the current study. Parallels between current results and the Theory of Planned Behavior are discussed in consideration of developing more effective MI-based interventions for adolescent smokers.     

Motivational concordance: an important mechanism in self-help therapeutic rituals involving inert (placebo) substances

We tested the contribution of two mechanisms, response expectancy and motivational concordance, to reported psychological benefit from a popular, biologically inactive, self-help, complementary therapy (a placebo). Flower essences were taken by 251 people for self-selected symptoms and were randomized to receive three different kinds of information. When the flower essence was presented as a spiritual therapy, then baseline spirituality (β=.35, P=.01) and expectancy (β=.25, P=.03) independently predicted outcome. When flower essences were presented as an affirmation (i.e., nonspiritual) therapy, then spirituality negatively (β=−.27, P=.03) and expectancy (β=.33, P=.01) predicted outcome. For both groups, expectancy predicted outcome after controlling for spirituality and compliance, but did not after controlling for ease of task completion. Expectancy failed to predict outcome in the nonenhanced ritual group. The results suggest that motivational concordance is an important therapeutic mechanism for real-life placebos.