Samantha Clutton

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

BackgroundProstate 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 mens and womens sexual and psychosocial adjustment after surgical treatment for localised prostate cancer; in addition to cost-effectiveness.Methods/designSeventy 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.DiscussionThe 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 RegistrationACTRN12608000358347

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

The diagnosis and treatment of prostate cancer is followed by substantive sexual morbidity. The optimal approach for intervening remains unclear.

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.

Pilot of a theoretically grounded psychologist-delivered intervention for fear of cancer recurrence (Conquer Fear)

Dear Editor,IntroductionFear of cancer recurrence (FCR), defined as the fear orworry that cancer could return or progress in the sameplace or another part of the body [1], is a commonand debilitating problem among cancer survivors. A re-cent systematic review found that across different cancersites and assessment strategies, the following on aver-age: 73% of cancer survivors report some degree ofFCR (range=39–97%); 49% report moderate to highFCR (range=22–87%); and 7% report high FCR(range=0–15%) [2]. FCR is stable over time and hasbeen shown to impact negatively on quality of life(QOL), psychological adjustment, emotional distressand anxiety, ability to establish future plans and carerQOL [2]. High FCR has also been associated withgreater medical service usage and costs [2]. Despitethe high prevalence, morbidity and potential cost ofFCR, survivors commonly report strong unmet needsfor help managing FCR [2]. This suggests many cancerservices are currently providing inadequate care in thisarea. Indeed, clinicians in psycho-oncology report diffi-culties dealing with high FCR [3]. There is a clear needfor interventions specifically targeting FCR, but veryfew have been developed and evaluated to date [4–6].This paper reports on the pilot testing of a novel, theo-retically based intervention for FCR.MethodsInterventionThe manualised intervention (Conquer Fear) aims to re-duce the impact of FCR and is based on the common-sense model (CSM) of illness [7], self-regulatory execu-tive function (S-REF) model [8] and Relational FrameTheory (RFT) [9]. Key intervention objectives includethe following: (a) teaching strategies for controllingworry and excessive threat monitoring (S-REF), (b)modifying unhelpful beliefs about worry (S-REF), (c)developing appropriate monitoring and screeningbehaviours (CSM), (d) providing information aboutfollow-up care and empirically supported behaviouralchange (e.g. weight loss and exercise) to reduce riskof recurrence (CSM), (e) addressing cancer-related exis-tential changes (RFT), and (f) promoting values-basedgoal-setting (RFT). The intervention comprises five60–90 min, individual face-to-face sessions with atrained psychologist/psychiatrist (therapist). Home-basedpractice and reading (≈2 h/week) is encouraged to con-solidate skills. See Table 1 for an overview of sessioncontent. More details are provided in Butow et al. [10].Study designThe feasibility, acceptability and likely efficacy ofConquer Fear were evaluated in a small longitudinalsingle-arm pilot study approved by relevant local ethicscommittees.

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.

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).

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)

Pilot of a theoretically grounded psychologist-delivered intervention for fear of cancer recurrence

Dear Editor,IntroductionFear of cancer recurrence (FCR), defined as the fear orworry that cancer could return or progress in the sameplace or another part of the body [1], is a commonand debilitating problem among cancer survivors. A re-cent systematic review found that across different cancersites and assessment strategies, the following on aver-age: 73% of cancer survivors report some degree ofFCR (range=39–97%); 49% report moderate to highFCR (range=22–87%); and 7% report high FCR(range=0–15%) [2]. FCR is stable over time and hasbeen shown to impact negatively on quality of life(QOL), psychological adjustment, emotional distressand anxiety, ability to establish future plans and carerQOL [2]. High FCR has also been associated withgreater medical service usage and costs [2]. Despitethe high prevalence, morbidity and potential cost ofFCR, survivors commonly report strong unmet needsfor help managing FCR [2]. This suggests many cancerservices are currently providing inadequate care in thisarea. Indeed, clinicians in psycho-oncology report diffi-culties dealing with high FCR [3]. There is a clear needfor interventions specifically targeting FCR, but veryfew have been developed and evaluated to date [4–6].This paper reports on the pilot testing of a novel, theo-retically based intervention for FCR.MethodsInterventionThe manualised intervention (Conquer Fear) aims to re-duce the impact of FCR and is based on the common-sense model (CSM) of illness [7], self-regulatory execu-tive function (S-REF) model [8] and Relational FrameTheory (RFT) [9]. Key intervention objectives includethe following: (a) teaching strategies for controllingworry and excessive threat monitoring (S-REF), (b)modifying unhelpful beliefs about worry (S-REF), (c)developing appropriate monitoring and screeningbehaviours (CSM), (d) providing information aboutfollow-up care and empirically supported behaviouralchange (e.g. weight loss and exercise) to reduce riskof recurrence (CSM), (e) addressing cancer-related exis-tential changes (RFT), and (f) promoting values-basedgoal-setting (RFT). The intervention comprises five60–90 min, individual face-to-face sessions with atrained psychologist/psychiatrist (therapist). Home-basedpractice and reading (≈2 h/week) is encouraged to con-solidate skills. See Table 1 for an overview of sessioncontent. More details are provided in Butow et al. [10].Study designThe feasibility, acceptability and likely efficacy ofConquer Fear were evaluated in a small longitudinalsingle-arm pilot study approved by relevant local ethicscommittees.

Pilot of a theoretically grounded psychologist-delivered intervention for fear of cancer recurrence (Conquer Fear): Conquer Fear: a promising new treatment for fear of cancer recurrence

Dear Editor,IntroductionFear of cancer recurrence (FCR), defined as the fear orworry that cancer could return or progress in the sameplace or another part of the body [1], is a commonand debilitating problem among cancer survivors. A re-cent systematic review found that across different cancersites and assessment strategies, the following on aver-age: 73% of cancer survivors report some degree ofFCR (range=39–97%); 49% report moderate to highFCR (range=22–87%); and 7% report high FCR(range=0–15%) [2]. FCR is stable over time and hasbeen shown to impact negatively on quality of life(QOL), psychological adjustment, emotional distressand anxiety, ability to establish future plans and carerQOL [2]. High FCR has also been associated withgreater medical service usage and costs [2]. Despitethe high prevalence, morbidity and potential cost ofFCR, survivors commonly report strong unmet needsfor help managing FCR [2]. This suggests many cancerservices are currently providing inadequate care in thisarea. Indeed, clinicians in psycho-oncology report diffi-culties dealing with high FCR [3]. There is a clear needfor interventions specifically targeting FCR, but veryfew have been developed and evaluated to date [4–6].This paper reports on the pilot testing of a novel, theo-retically based intervention for FCR.MethodsInterventionThe manualised intervention (Conquer Fear) aims to re-duce the impact of FCR and is based on the common-sense model (CSM) of illness [7], self-regulatory execu-tive function (S-REF) model [8] and Relational FrameTheory (RFT) [9]. Key intervention objectives includethe following: (a) teaching strategies for controllingworry and excessive threat monitoring (S-REF), (b)modifying unhelpful beliefs about worry (S-REF), (c)developing appropriate monitoring and screeningbehaviours (CSM), (d) providing information aboutfollow-up care and empirically supported behaviouralchange (e.g. weight loss and exercise) to reduce riskof recurrence (CSM), (e) addressing cancer-related exis-tential changes (RFT), and (f) promoting values-basedgoal-setting (RFT). The intervention comprises five60–90 min, individual face-to-face sessions with atrained psychologist/psychiatrist (therapist). Home-basedpractice and reading (≈2 h/week) is encouraged to con-solidate skills. See Table 1 for an overview of sessioncontent. More details are provided in Butow et al. [10].Study designThe feasibility, acceptability and likely efficacy ofConquer Fear were evaluated in a small longitudinalsingle-arm pilot study approved by relevant local ethicscommittees.