Mindfulness-Based Cognitive Therapy in Advanced Prostate Cancer: A Randomized Controlled Trial.

Purpose Advanced prostate cancer (PC) is associated with substantial psychosocial morbidity. We sought to determine whether mindfulness-based cognitive therapy (MBCT) reduces distress in men with advanced PC. Methods Men with advanced PC (proven metastatic and/or castration-resistant biochemical progression) were randomly assigned to an 8-week, group-based MBCT intervention delivered by telephone (n = 94) or to minimally enhanced usual care (n = 95). Primary intervention outcomes were psychological distress, cancer-specific distress, and prostate-specific antigen anxiety. Mindfulness skills were assessed as potential mediators of effect. Participants were assessed at baseline and were followed up at 3, 6, and 9 months. Main statistical analyses were conducted on the basis of intention to treat. Results Fourteen MBCT groups were conducted in the intervention arm. Facilitator adherence ratings were high (> 93%). Using random-effects mixed-regression models, intention-to-treat analyses indicated no significant changes in intervention outcomes or in engagement with mindfulness for men in MBCT compared with those receiving minimally enhanced usual care. Per-protocol analyses also found no differences between arms in outcomes or engagement, with the exception of the mindfulness skill of observing, which increased over time for men in MBCT compared with usual care ( P = .032). Conclusion MBCT in this format was not more effective than minimally enhanced usual care in reducing distress in men with advanced PC. Future intervention research for these men should consider approaches that map more closely to masculinity.

Economic evaluation of a psychological intervention for high distress cancer patients and carers: costs and quality-adjusted life years.

OBJECTIVE: This study compared the cost-effectiveness of a psychologist-led, individualised cognitive behavioural intervention (PI) to a nurse-led, minimal contact self-management condition for highly distressed cancer patients and carers. METHODS: This was an economic evaluation conducted alongside a randomised trial of highly distressed adult cancer patients and carers calling cancer helplines. Services used by participants were measured using a resource use questionnaire, and quality-adjusted life years were measured using the assessment of quality of life - eight-dimension - instrument collected through a computer-assisted telephone interview. The base case analysis stratified participants based on the baseline score on the Brief Symptom Inventory. Incremental cost-effectiveness ratio confidence intervals were calculated with a nonparametric bootstrap to reflect sampling uncertainty. The results were subjected to sensitivity analysis by varying unit costs for resource use and the method for handling missing data. RESULTS: No significant differences were found in overall total costs or quality-adjusted life years (QALYs) between intervention groups. Bootstrapped data suggest the PI had a higher probability of lower cost and greater QALYs for both carers and patients with high distress at baseline. For patients with low levels of distress at baseline, the PI had a higher probability of greater QALYs but at additional cost. Sensitivity analysis showed the results were robust. CONCLUSIONS: The PI may be cost-effective compared with the nurse-led, minimal contact self-management condition for highly distressed cancer patients and carers. More intensive psychological intervention for patients with greater levels of distress appears warranted. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer.

BACKGROUND: Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity. METHODS/DESIGN: A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial. DISCUSSION: This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention. TRIAL REGISTRATION: ACTRN12611000392965.

Beating the blues after cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers.

BACKGROUND: The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. METHODS/DESIGN: 140 patients and 140 carers per condition (560 participants in total) will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1) a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2) a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. DISCUSSION: The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. TRIAL REGISTRATION: ACTRN12609000301268.

The application of the heuristic-systematic processing model to treatment decision making about prostate cancer.

The study investigated the utility of the Heuristic-Systematic Processing Model as a framework for the investigation of patient decision making. A total of 111 men recently diagnosed with localized prostate cancer were assessed using Verbal Protocol Analysis and self-report measures. Study variables included men's use of nonsystematic and systematic information processing, desire for involvement in decision making, and the individual differences of health locus of control, tolerance of ambiguity, and decision-related uncertainty. Most men (68%) preferred that decision making be shared equally between them and their doctor. Men's use of the expert opinion heuristic was related to men's verbal reports of decisional uncertainty and having a positive orientation to their doctor and medical care; a desire for greater involvement in decision making was predicted by a high internal locus of health control. Trends were observed for systematic information processing to increase when the heuristic strategy used was negatively affect laden and when men were uncertain about the probabilities for cure and side effects. There was a trend for decreased systematic processing when the expert opinion heuristic was used. Findings were consistent with the Heuristic-Systematic Processing Model and suggest that this model has utility for future research in applied decision making about health.