Benefits of a brief psychological intervention targeting fear of cancer recurrence in people at high risk of developing another melanoma: 12-month follow-up results of a randomized controlled trial.

BACKGROUND: People with melanoma want and need effective interventions for living with fear of cancer recurrence (FCR). OBJECTIVES: This study reports the 12-month outcomes of a brief, psychological intervention designed to reduce FCR in people at high risk of developing another primary melanoma compared with usual care. METHODS: In this two-arm randomized controlled trial, adults previously diagnosed with stage 0, I or II melanoma were randomly allocated to the intervention (n = 80) or control (usual care) arm (n = 84). The trial was registered with the Australian and New Zealand Clinical Trials Registry on 19 March 2013 (registration: ACTRN12613000304730). The intervention comprised a 76-page psychoeducational resource and three individually tailored, telephone-based sessions with a psychologist, scheduled at specific time points around participants' dermatological appointments. The primary outcome was the level of self-reported fear of new or recurrent melanoma assessed at 12 months postintervention using the severity subscale of the Fear of Cancer Recurrence Inventory. RESULTS: Compared with the control arm, the intervention group reported significantly lower FCR at 12 months postintervention; the between-group mean difference was -1·41 for FCR severity [95% confidence interval (CI) -2·6 to -0·2; P = 0·02] and -1·32 for FCR triggers (95% CI -2·6 to -0·02; P = 0·04). The odds ratio for FCR severity scores ≥13 (54% intervention, 63% control) was 0·59 (95% CI 0·30-1·14, P = 0·12). There were no differences between groups in secondary outcomes, such as anxiety, depression or health-related quality of life. CONCLUSIONS: The previously reported 6-month benefits of this brief, patient-centred psychological intervention in reducing FCR were found to continue 12 months postintervention, with no known adverse effects, supporting implementation as part of routine melanoma care.

Implementation of Early Intervention Protocol in Australia for 'High Risk' Injured Workers is Associated with Fewer Lost Work Days Over 2 Years Than Usual (Stepped) Care.

Purpose To evaluate whether a protocol for early intervention addressing the psychosocial risk factors for delayed return to work in workers with soft tissue injuries would achieve better long-term outcomes than usual (stepped) care. Methods The study used a controlled, non-randomised prospective design to compare two case management approaches. For the intervention condition, workers screened within 1-3 weeks of injury as being at high risk of delayed returned to work by the Örebro Musculoskeletal Pain Screening Questionnaire-short version (ÖMPSQ-SF) were offered psychological assessment and a comprehensive protocol to address the identified obstacles for return to work. Similarly identified injured workers in the control condition were managed under usual (stepped) care arrangements. Results At 2-year follow-up, the mean lost work days for the Intervention group was less than half that of the usual care group, their claim costs were 30% lower, as was the growth trajectory of their costs after 11 months. Conclusions The findings supported the hypothesis that brief psychological risk factor screening, combined with a protocol for active collaboration between key stakeholders to address identified psychological and workplace factors for delayed return to work, can achieve better return on investment than usual (stepped) care.

Predicting Return to Work in a Heterogeneous Sample of Recently Injured Workers Using the Brief ÖMPSQ-SF.

Purpose (1) to examine the ability of the Örebro Musculoskeletal Pain Screening Questionnaire-short version (ÖMPSQ-SF) to predict time to return to pre-injury work duties (PID) following a work-related soft tissue injury (regardless of body location); and (2) to examine the appropriateness of 50/100 as a suitable cut-off score for case identification. Methods Injured workers (IW) from six public hospitals in Sydney, Australia, who had taken medically-sanctioned time off work due to their injury, were recruited by insurance case managers within 5-15 days of their injury. Eligible participants (N = 213 in total) were administered the ÖMPSQ-SF over the telephone by the case manager. For objective (1) Cox proportional hazards regression analysis was used to predict days to return to PID using the ÖMPSQ-SF. For objective (2) receiver operator characteristic (ROC) analysis was used to determine the ÖMPSQ-SF total score that optimises sensitivity and specificity in detecting whether or not participants had returned to PID within 2-7 weeks. Results The total ÖMPSQ-SF score significantly predicted number of days to return to PID, such that for every 1-point increase in the total ÖMPSQ-SF score the predicted chance of returning to work reduced by 4% (i.e., hazard ratio = 0.96), p < 0.001. Sensitivity and specificity for the ROC analysis comparing ÖMPSQ-SF total score to return to PID within 2-7 weeks suggested 48 as the optimal cut off (sensitivity = 0.65, specificity = 0.79). Conclusion The results provide strong support for the use of the ÖMPSQ-SF in an applied setting for identifying those IW likely to have delayed RTW when administered within 15 days of the injury. While a score of 48/100 was the optimal cut point for sensitivity and specificity, pragmatically, 50/100 should be acceptable as a cut-off in future studies of this type.

Correction to: Implementation of Early Intervention Protocol in Australia for 'High Risk' Injured Workers is Associated with Fewer Lost Work Days Over 2 Years Than Usual (Stepped) Care.

The original version of this article unfortunately contained a spelling error in one of the co-authors's names. The family name of the co-author was incorrectly displayed as "James McCauley" instead of "James McAuley. The original article has been corrected.

Correlates of unmet needs and psychological distress in adolescent and young adults who have a parent diagnosed with cancer.

OBJECTIVE: Young people who have a parent with cancer experience elevated levels of psychological distress and unmet needs. In this study, we examined the associations between demographics, cancer variables and family functioning and levels of distress and unmet needs amongst young people who have a parent diagnosed with cancer. METHODS: Young people aged 12-24 years with a parent with cancer (n = 255) completed the Offspring Cancer Needs Instrument (unmet needs), the Kessler-10 (distress) and the Family Relationship Index (family functioning), along with measures of demographics and cancer variables (such as age, sex and time since cancer diagnosis). Variables associated with distress and unmet needs (including unmet need domains) were assessed using multiple linear regression. RESULTS: Being female and older, having more unmet cancer needs and poorer family functioning were associated with increased distress. Having a father with cancer, a shorter time since diagnosis and poor family functioning were associated with increased unmet needs. Family conflict and expressiveness were particularly important components of family functioning. Having a parent relapse with cancer was also associated with unmet needs in the domains of practical assistance, 'time out' and support from other young people who have been through something similar. CONCLUSIONS: Delineating factors associated with increased distress and unmet needs assist in identifying at-risk young people allowing improved assessment and tailoring of support to improve the psychosocial outcomes of young people impacted by parental cancer.

Phase 1 in the development of a patient-reported measure to quantify perceived inconvenience of radiotherapy: generation of issues.

AIMS: Current patient-reported measures (PROMs) do not specifically address radiotherapy (RT) related inconvenience. We conducted, as per guidelines of the European Organization for Research and Treatment of Cancer (EORTC), the initial (issue generation) phase of development of a RT inconvenience PROM. Specifically, we aimed to develop a conceptual framework for RT inconvenience and generate a comprehensive list of issues pertaining to it. METHODS: We reviewed existing PROMs and literature and gathered qualitative and quantitative data from consumers and health professionals, in order to generate a comprehensive list of issues pertaining to RT inconvenience. A framework for the consideration of RT inconvenience was defined and used to ensure all possible issues were explored and to list the issues into conceptual domains. RESULTS: Qualitative data from 26 consumers and 30 health professionals, and quantitative data from 1191 consumers and 253 health professionals resulted in the identification of 38 issues grouped into five conceptual domains: (1) inconvenience of RT opportunity, (2) inconvenience of decision-making, (3) inconvenience of treatment, (4) inconvenience of side effects, and (5) inconvenience of follow-up. CONCLUSIONS: This list of RT inconvenience issues will, in future work, be operationalized into a set of items for pretesting and then large-scale field testing as per the EORTC guidelines.

QLU-C10D: a health state classification system for a multi-attribute utility measure based on the EORTC QLQ-C30.

PURPOSE: To derive a health state classification system (HSCS) from the cancer-specific quality of life questionnaire, the EORTC QLQ-C30, as the basis for a multi-attribute utility instrument. METHODS: The conceptual model for the HSCS was based on the established domain structure of the QLQ-C30. Several criteria were considered to select a subset of dimensions and items for the HSCS. Expert opinion and patient input informed a priori selection of key dimensions. Psychometric criteria were assessed via secondary analysis of a pooled dataset comprising HRQOL and clinical data from 2616 patients from eight countries and a range of primary cancer sites, disease stages, and treatments. We used confirmatory factor analysis (CFA) to assess the conceptual model's robustness and generalisability. We assessed item floor effects (>75 % observations at lowest score), disordered item response thresholds, coverage of the latent variable and differential item function using Rasch analysis. We calculated effect sizes for known group comparisons based on disease stage and responsiveness to change. Seventy-nine cancer patients assessed the relative importance of items within dimensions. RESULTS: CFA supported the conceptual model and its generalisability across primary cancer sites. After considering all criteria, 12 items were selected representing 10 dimensions: physical functioning (mobility), role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems. CONCLUSIONS: The HSCS created from QLQ-C30 items is known as the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The next phase of the QLU-C10D's development involves valuation studies, currently planned or being conducted across the globe.

Using a discrete choice experiment to value the QLU-C10D: feasibility and sensitivity to presentation format.

PURPOSE: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats. METHODS: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task. RESULTS: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results. CONCLUSION: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D.

Testing the measurement invariance of the EORTC QLQ-C30 across primary cancer sites using multi-group confirmatory factor analysis.

PURPOSE: The EORTC Quality of Life Questionnaire is a widely used cancer-specific quality of life instrument comprising a core set of 30 items (QLQ-C30) supplemented by cancer site-specific modules. The purpose of this paper was to examine the extent to which the conventional multi-item domain structure of the QLQ-C30 holds across patients with seven different primary cancer sites. METHODS: Multi-group confirmatory factor analysis was used to test whether a measurement model of the QLQ-C30 was invariant across cancer sites. Configural (same patterns of factor loadings), metric (equivalence of factor loadings) and scalar (equivalence of thresholds) invariance amongst the cancer site groups were assessed (N = 1,906) by comparing the fit of a model with these parameters freely estimated to a model where estimates were constrained to be equal for the corresponding items in each group. RESULTS: All groups exhibited good model fit except for the prostate group, which was excluded. Only 1 of 576 parameters was found to differ between primary sites: specifically, the first threshold of Item 1 in the breast cancer group exhibited non-invariance. In a post hoc analysis, several instances of non-invariance by treatment status (baseline, on-treatment, off-treatment) were observed. CONCLUSIONS: Given only one instance of non-invariance between cancer sites, there is a reason to be confident in the validity of conclusions drawn when comparing QLQ-C30 domain scores between different sites and when interpreting the scores of heterogeneous samples, although future research should assess the potential impact of confounding variables such as treatment and gender.

Psychometric evaluation of the Sibling Cancer Needs Instrument (SCNI): an instrument to assess the psychosocial unmet needs of young people who are siblings of cancer patients.

PURPOSE: The current study sought to establish the psychometric properties of the revised Sibling Cancer Needs Instrument (SCNI) when completed by young people who have a brother or sister with cancer. METHODS: The participants were 106 young people aged between 12 and 24 who had a living brother or sister diagnosed with any type or stage of cancer in the last 5 years. They were recruited from multiple settings. The initial step in determining the dimensional structure of the questionnaire was exploratory factor analysis and further assessment followed using Rasch analysis. Construct validity and test-retest reliability (n = 17) were also assessed. RESULTS: The final SCNI has 45 items and seven domains: information; practical assistance; "time out" and recreation; feelings; support (friends and other young people); understanding from my family; and sibling relationship. There was a reasonable spread of responses across the scale for every item. Rasch analysis results suggested that overall, respondents used the scale consistently. Support for construct validity was provided by the correlations between psychological distress and the SCNI domains. The internal consistency was good to excellent; Cronbach's alphas ranged from 0.78 to 0.94. The test-retest reliability of the overall measure is 0.88. CONCLUSIONS: The SCNI is the first measure of psychosocial unmet needs which has been developed for young people who have a brother or sister with cancer. The sound psychometric properties allow the instrument to be used with confidence. The measure will provide a substantial clinical benefit in highlighting the unmet needs of this population to assist with the prioritisation of targeted supportive care services and evaluating the impact of interventions targeted at siblings.

Psychometric evaluation of the Offspring Cancer Needs Instrument (OCNI): an instrument to assess the psychosocial unmet needs of young people who have a parent with cancer.

PURPOSE: The current study sought to establish the psychometric properties of the revised Offspring Cancer Needs Instrument (OCNI) when completed by a large sample of young people impacted by parental cancer recruited from multiple settings. METHODS: The psychometric properties were evaluated with 256 young people aged between 12 and 24 who had a parent or primary caregiver diagnosed with any type or stage of cancer within the last 5 years and who was still living. Exploratory factor analysis was conducted as an initial step in determining the dimensional structure of the questionnaire, and further assessment followed using Rasch analysis. Construct validity and test-retest reliability (n = 35) were also assessed. RESULTS: The final OCNI has 47 items and 7 domains: information, family issues, practical assistance, time out, feelings, support (friends) and support (other young people). There was a reasonable spread of responses across the scale for every item, and Rasch analysis results suggested that overall, respondents used the scale consistently. The retest correlation for the overall measure was 0.73. Support for construct validity was provided by the correlations between psychological distress and the OCNI domains. The internal consistency was excellent; the lowest domain Cronbach alpha is 0.89. CONCLUSIONS: The OCNI is the first measure of psychosocial unmet needs which has been developed specifically for young people who have a parent with cancer. It has sound psychometric properties and will provide substantial clinical benefit in identifying the unmet needs of this population to assist with the provision of targeted supportive care services.

A Psychosexual Rehabilitation Booklet Increases Vaginal Dilator Adherence and Knowledge in Women Undergoing Pelvic Radiation Therapy for Gynaecological or Anorectal Cancer: A Randomised Controlled Trial.

AIMS: Women treated with pelvic radiation therapy (PRT) for gynaecological or anorectal cancer report a high number of sexual problems and unmet post-treatment psychosexual information needs. Currently, there is suboptimal adherence to recommended rehabilitation aids, such as vaginal dilators, and a paucity of resources to facilitate post-radiation rehabilitation and reduce distress in this population. This randomised controlled trial aimed to evaluate the effectiveness of a study-developed psychosexual rehabilitation booklet in this setting. MATERIALS AND METHODS: Eighty-two women scheduled for PRT to treat gynaecological/anorectal cancer were randomised to receive the intervention booklet (n = 44) or standard information materials (n = 38). Self-report questionnaires administered at pre-treatment baseline and at 3, 6 and 12 months post-treatment assessed adherence with rehabilitation aids, booklet knowledge, anxiety, depression and sexual functioning/satisfaction. RESULTS: Dilator adherence and booklet knowledge were significantly higher in the intervention group than in the control group (averaged over time points), with scores significantly increasing over time. Younger age and gynaecological cancer were significant predictors of greater dilator adherence. No significant group differences were found on psychological and sexual measures. CONCLUSIONS: The psychosexual rehabilitation booklet was effective in educating women with gynaecological and anorectal cancers about PRT-related psychosexual side-effects and rehabilitation options, as well as promoting uptake of vaginal dilator use. Future research should elucidate the effectiveness of this booklet in women with greater psychological and sexual functioning needs.

Regional variation in immediate breast reconstruction in Australia.

BACKGROUND: Breast reconstruction following mastectomy has proven benefits and is the standard of care in many high-income countries. This audit documented regional variation in immediate breast reconstruction rates across Australia. METHODS: The Breast Surgeons of Australia and New Zealand (BreastSurgANZ) Quality Audit database and geospatial software were used to model the distribution of breast reconstructions performed on women having mastectomy in Australia in 2013. Geospatial mapping identified the distribution of these procedures in relation to the Greater Capital City Statistical Areas (GCCSAs) of the five largest states. Data were analysed using χ2 tests of independence and an independent-samples t test. RESULTS: Of 3786 patients having a mastectomy, 692 underwent breast reconstruction of which 679 (98·1 per cent) were immediate reconstructions. Rates of reconstruction differed significantly between jurisdictions (χ2 = 164·90), and were significantly higher in GCCSAs (χ2 = 144·60) and private hospitals (χ2 = 50·72) (all P < 0·001). Immediate breast reconstruction was not reported for 43·8 per cent of hospitals where mastectomy was conducted by members of BreastSurgANZ, including 29·8 per cent of hospitals within GCCSAs. A wider age range of women appeared to have had immediate reconstructions at hospitals within GCCSAs, although the difference in mean age between regions was not significant. Immediate breast reconstruction was considerably less likely to be performed in women who lived in areas of lower to mid socioeconomic status. CONCLUSION: Variations in the rate of immediate breast reconstruction may not be purely resource-driven.

Protocol for a within-trial economic evaluation of a psychoeducational intervention tailored to people at high risk of developing a second or subsequent melanoma.

INTRODUCTION: Psychological support programmes are not currently funded for people with a history of melanoma. A major barrier to the implementation of effective psychological interventions in routine clinical care is a lack of cost-effectiveness data. This paper describes the planned economic evaluation alongside a randomised controlled trial of a psychoeducational intervention for people with a history of melanoma who are at high risk of developing new primary disease. METHOD AND ANALYSIS: The economic evaluation is a within-trial analysis to evaluate the incremental costs and health outcomes of a psychoeducational intervention compared to usual care from the perspective of the Australian healthcare system. Cost-effectiveness and cost-utility analyses will be conducted, providing estimates of the cost to reduce fear of melanoma recurrence and the cost per quality-adjusted life-year (QALY) gained. Fear of melanoma recurrence will be measured using the Fear of Cancer Recurrence Inventory and preference-based quality of life measured using the Assessment of Quality of Life-8 Dimensions (AQoL-8D) instrument. The AQoL-8D will provide utilities for estimation of QALYs in the cost-utility analysis. Unit costs of health services and medicines will be taken from the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme national databases. Health outcomes, and health service and medication use will be collected at baseline, 6 and 12 months follow-up. The within-trial analysis will be conducted at 12 months, consistent with the end point of the trial. ETHICS AND DISSEMINATION: Approval to conduct the study was granted by the Sydney Local Health District (RPAH zone) Ethics Review Committee (X13-0065 and HREC/13/RPAH/86), the Department of Health and Ageing Human Research Ethics Committee (21/2013), the University of Sydney Human Research Ethics Committee (2013/595), and the Australian Institute of Health and Welfare Ethics Committee (EO 2013/4/58). TRIAL REGISTRATION NUMBER: ACTRN12613000304730; Pre-results.

Acupuncture for treatment of arthralgia secondary to aromatase inhibitor therapy in women with early breast cancer: pilot study.

BACKGROUND: Aromatase inhibitors (AIs) are recommended as adjuvant hormone treatment for postmenopausal women with early breast cancer. A substantial proportion of women taking AIs experience joint pain and stiffness. Studies have suggested that acupuncture may be effective in treating joint pain. OBJECTIVE: A pilot study was conducted to evaluate the feasibility, safety and efficacy of using acupuncture to treat AI-induced arthralgia. METHODS: A total of 32 patients were randomised to receive either sham or real electroacupuncture (EA) twice weekly for 6 weeks. Outcomes of joint pain, stiffness and physical function were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), overall pain severity and interference with the BPI-SF and quality of life (QOL) with the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. Hand strength was assessed by a grip test, and a serum marker of inflammation (C reactive protein (CRP)) was also measured. All assessments were performed at baseline, 6 weeks and 12 weeks, except for blood samples at baseline and 6 weeks only. RESULTS: No serious adverse events were reported during or after acupuncture treatments. There were no significant differences in outcome measures. However, positive trends were observed in stiffness and physical function at week 12 in favour of real EA. CONCLUSIONS: Findings suggest that acupuncture is feasible and safe in patients with breast cancer with joint pain caused by AI. A larger study with adequately powered to confirm these results and detect clinically relevant effects is needed.