Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial.

BACKGROUND: Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed. OBJECTIVE: The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress. METHODS: A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life. RESULTS: Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention. CONCLUSIONS: This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613001026718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364768&isReview=true (Archived by WebCite at http://www.webcitation.org/6uPvpcovl).

A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope.

INTRODUCTION: Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. METHODS AND ANALYSIS: In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ≥4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed, this study will provide recommendations about the efficacy of web-based cognitive behavioural interventions to facilitate better psychosocial adjustment for people with cancer. TRIAL REGISTRATION NUMBER: ANZCTR (ACTRN12613001026718).

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.

The role of mindfulness in distress and quality of life for men with advanced prostate cancer.

OBJECTIVE: To examine the extent to which mindfulness skills influence psychological distress and health-related quality of life (HRQOL) in men with metastatic or castration-resistant biochemical progression of prostate cancer. PATIENTS AND METHODS: A cross-sectional survey of 190 men (46 % response; mean age 71 years, SD = 8.7, range 40-91 years) with advanced prostate cancer, assessed psychological and cancer-specific distress, HRQOL. Mindfulness skills were assessed as potential predictors of adjustment outcomes. RESULTS: Overall, 39 % of men reported high psychological distress. One third had accessed psychological support previously although only 10 % were under current psychological care. One quarter had accessed a prostate cancer support group in the past six months. Higher HRQOL and lower cancer-specific and global psychological distress were related to non-judging of inner experience (p < 0.001). Higher HRQOL and lower psychological distress were related to acting with awareness (p < 0.001). Lower distress was also related to higher non-reactivity to inner experience and a lower level of observing (p < 0.05). CONCLUSIONS: Men with advanced prostate cancer are at risk of poor psychological outcomes. Psychological flexibility may be a promising target for interventions to improve adjustment outcomes in this patient group. CLINICAL TRIAL REGISTRY: Trial Registration: ACTRN12612000306819.

A randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer and their female partners.

OBJECTIVE: The diagnosis and treatment of prostate cancer is followed by substantive sexual morbidity. The optimal approach for intervening remains unclear. METHODS/DESIGN: A three-arm randomised control trial was undertaken with 189 heterosexual couples where the man had been diagnosed with prostate cancer and treated surgically. The efficacy of peer-delivered telephone support versus nurse-delivered telephone counselling versus usual care in improving both men's and women's sexual adjustment was investigated. Assessments were undertaken at baseline (pre-test) with follow-up at 3, 6 and 12 months. RESULTS: At 12 months, men in the peer (p = 0.016) and nurse intervention (p = 0.008) were more likely to use medical treatments for erectile dysfunction (ED) than men in the usual care arm. Men in the nurse intervention more frequently used oral medication for ED than men in usual care (p = 0.002). No significant effects were found for sexual function, sexuality needs, sexual self-confidence, masculine self-esteem, marital satisfaction or intimacy. CONCLUSION: Although peer and nurse couples-based interventions can increase use of medical treatments for ED, this may not translate into better sexual or relationship outcomes. More research is needed into the optimal timing of interventions to improve sexual outcomes for men with prostate cancer and to identify the subpopulations that will benefit from them.

Couple distress after localised prostate cancer.

BACKGROUND: The experience of the diagnosis of prostate cancer is distressing for both men and their partners. The present study describes the prevalence of psychological distress in men with prostate cancer and their partners, and the predictors of adjustment outcomes. METHODS/DESIGN: A cross-sectional survey of 189 prostate cancer patients who were scheduled for or had undergone surgery for localised prostate cancer and their partners assessed socio-demographic variables, masculine self-esteem and social intimacy, psychological adjustment and quality of life. RESULTS: Overall, patients and partners reported low distress; however, female partners were more anxious with 36 % reporting mild to severe anxiety. For men, masculine self-esteem and time since diagnosis were most strongly related to mental health status; urinary bother most influenced physical quality of life. For female partners, the man's psychological distress and his sexual bother were most strongly related to her mental health status; higher social intimacy was most strongly associated with physical quality of life. CONCLUSION: The correlates of distress after the diagnosis of prostate cancer differ between patients and female partners. For men, masculine self-esteem may be most crucial, whereas for women, her partner's level of distress may matter most. Research to better understand these interactions is needed.

A randomised controlled trial of a mindfulness intervention for men with advanced prostate cancer.

BACKGROUND: Prostate cancer is the most common male cancer in developed countries, and in Australia approximately one-fifth of men with prostate cancer have advanced disease. By comparison to men with localised prostate cancer, men with advanced disease report higher levels of psychological distress; poorer quality of life; and have an increased risk of suicide. To date no psychological intervention research specifically targeting men with advanced prostate cancer has been reported. In this paper we present the protocol of a current randomised controlled trial to assess the effectiveness of a professionally-led mindfulness-based cognitive therapy (MBCT) group intervention to improve psychological well-being in men with advanced prostate cancer. METHODS/DESIGN: Ninety-five men per condition (190 men in total) will be recruited through clinicians in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and in major treatment centres in Queensland, New South Wales, Victoria and Western Australia. Patients are randomised to: (1) tele-based MBCT intervention or (2) patient education. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment, and at 3, 6, and 9 months after recruitment and intervention commencement. Engagement with the principles of mindfulness and adherence to practice will be included as potential mediators of intervention effect. Primary outcomes are anxiety, depression and cancer-specific distress. Secondary outcomes are health-related quality of life (QoL) and benefit finding. Disease variables (e.g. cancer grade, stage) will be assessed through medical records. DISCUSSION: This study will address a critical but as yet unanswered research question: to identify an effective way to reduce psychological distress; and improve the quality of life for men with advanced prostate cancer. TRIAL REGISTRATION: http://ACTRN12612000306819.

Mindfulness groups for men with advanced prostate cancer: a pilot study to assess feasibility and effectiveness and the role of peer support.

PURPOSE: Men diagnosed with advanced prostate cancer experience higher psychological distress and greater unmet supportive care needs than men with localized disease. A mindfulness-based cognitive therapy group intervention was pilot tested for acceptability and effectiveness in this patient group. METHODS: Nineteen men were initially recruited to three groups and 12 completed final assessments. Outcomes assessed included anxiety, depression, cancer-related distress, prostate cancer-specific quality of life, and mindfulness skills at baseline, immediately, and 3 months post-intervention. Satisfaction measures and in-depth interviews were undertaken post-intervention to describe men's personal experiences of the groups. RESULTS: Significant improvements were observed for anxiety (p = 0.027), avoidance (p = 0.032), and mindfulness skills (p = 0.019), with a trend for a reduction in fear of cancer recurrence (p = 0.062). Effect sizes were moderate to large. A shared group identity, acceptance of, and learning from other group members were key aspects of the group context that contributed to acceptance of progressive disease. CONCLUSIONS: Mindfulness-based group interventions appear to have utility in this patient group and show promise for reducing anxiety, avoidance, and fear of cancer recurrence. Peer learning appeared to be helpful in generating acceptance of advancing disease.

A community-based approach to cancer counselling for patients and carers: a preliminary study.

OBJECTIVE: The delivery of psychological care services to people with cancer and their carers is a key clinical priority that has yet to be broadly implemented. The present study aimed to provide guidance for service provision by describing a community-based intervention approach; outlining the characteristics, psychological concerns, and distress outcomes for people who utilise the service. METHODS: Over a 3-year period 681 patients and 520 significant others referred from a community-based Cancer Helpline received tele-based psychosocial interventions. RESULTS: In this case series presenting problems varied between patients and significant others, with significant others reporting higher levels of distress (p<0.001). Both patients and significant others experienced decreases in distress over the period of the intervention (p<0.001). CONCLUSIONS: This study provides level IV evidence that the tele-based intervention for cancer-related distress is an effective approach to service delivery. A randomised control trial is currently underway to assess the effectiveness of this approach.

ProsCan for Couples: randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer who receive radical prostatectomy.

BACKGROUND: Prostate cancer is the most common male cancer in the Western world. The most substantial long term morbidity from this cancer is sexual dysfunction with consequent adverse changes in couple and intimate relationships. Research to date has not identified an effective way to improve sexual and psychosocial adjustment for both men with prostate cancer and their partners. As well, the efficacy and cost effectiveness of peer counselling as opposed to professional models of service delivery has not yet been empirically tested. This paper presents the design of a three arm randomised controlled trial (peer vs. nurse counselling vs. usual care) that will evaluate the efficacy of two couples-based sexuality interventions (ProsCan for Couples: Peer support vs. nurse counselling) on men's and women's sexual and psychosocial adjustment after surgical treatment for localised prostate cancer; in addition to cost-effectiveness. METHODS/DESIGN: Seventy couples per condition (210 couples in total) will be recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to (1) usual care; (2) eight sessions of peer-delivered telephone support with DVD education; and (3) eight sessions of oncology nurse-delivered telephone counselling with DVD education. Two intervention sessions will be delivered before surgery and six over the six months post-surgery. The intervention will utilise a cognitive behavioural approach along with couple relationship education focussed on relationship enhancement and helping the couple to conjointly manage the stresses of cancer diagnosis and treatment. Participants will be assessed at baseline (before surgery) and 3, 6 and 12 months post-surgery. Outcome measures include: sexual adjustment; unmet sexuality supportive care needs; attitudes to sexual help seeking; psychological adjustment; benefit finding and quality of life. DISCUSSION: The study will provide recommendations about the efficacy of peer support vs. nurse counselling to facilitate better sexual and couple adjustment after prostate cancer as well as recommendations on whether the interventions represent efficient health service delivery. TRIAL REGISTRATION: ACTRN12608000358347.

Early decision and psychosocial support intervention for men with localised prostate cancer: an integrated approach.

GOAL: Men diagnosed with prostate cancer experience high decision-related distress concurrent with cancer-related distress. Psycho-education, problem solving and decision support were integrated in a novel telephone-delivered supportive care intervention targeting men at diagnosis and assessed for feasibility. MATERIALS AND METHODS: An exploratory single-group pre-post-test design tracked session frequency, duration and content. Standardised measures assessed decisional conflict, cancer-related distress and decision involvement. Brief screening measures for psychological and decision-related distress were incorporated into the intervention protocol. Twenty men (77% response) newly diagnosed with localised prostate cancer received the intervention. RESULTS: Men who were undecided about treatment at study entry required more pre-treatment intervention calls (p < 0.013). Pre-treatment support calls were longer (M = 40.2 min) and more complex by comparison to post-treatment calls (M = 30.9 min; p < 0.002). Brief screening for decision-related distress correlated with concurrent (p < 0.008) and prospective (p < 0.046) decisional conflict. Decisional conflict and intrusion decreased at post-test (p < 0.001; p < 0.005). Men reported a high level of satisfaction with the support received with benefits identified including anonymity and accessibility. CONCLUSIONS: In this setting, a tele-based supportive care and decision support intervention for men newly diagnosed with prostate cancer was feasible. The use of brief screening measures as within-intervention clinical tools appears promising.