Methadone rotation versus other opioid rotation for refractory cancer induced bone pain: protocol of an exploratory randomised controlled open-label study.

BACKGROUND: A third of patients with advanced cancer and bone metastasis suffer from cancer induced bone pain (CIBP), impeding quality of life, psychological distress, depression and anxiety. This study will evaluate the impact of an opioid rotation, comparing methadone rotation with other opioid rotation in patients with refractory CIBP. METHODS: This open-label randomised controlled trial will recruit cancer patients with CIBP and inadequate pain control despite established baseline opioid and/or intolerable opioid side effects from cancer and palliative care services. Participants will be at least 18 years old, with a predicted prognosis of greater than 8 weeks, meet the core diagnostic criteria for CIBP, have a worst pain score of ≥ 4 of 10 from CIBP and/ or have opioid toxicity (graded ≥ 2 on Common Terminology Criteria for Adverse Events). Participants will have sufficiently proficient English to complete questionnaires and provide informed consent. Participants will be randomised 1:1 to be rotated to methadone to another opioid. The primary objective is to examine the impact of opioid rotation in improving CIBP by comparing analgesic efficacy, safety and tolerability in the two arms. Secondary objectives will assess changes in the intensity, duration and frequency of breakthrough pain, requirement of breakthrough analgesia, overall opioid escalation index, and time taken to observe improvement in pain reduction, pain interference and quality of life. DISCUSSION: Laboratory studies suggest the involvement of neuropathic involvement in the mechanism of CIBP, though there remains no clear evidence of the routine use of neuropathic agents. Methadone as an analgesic agent may have a role to play in this cohort of patients, thus warranting further exploratory studies. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry No: ACTRN12621000141842. Registered 11 February 2021.

The Edmonton Classification System for Cancer Pain in Patients with Bone Metastasis: a descriptive cohort study.

PURPOSE: We describe the prevalence of the Edmonton Classification System for Cancer Pain (ECS-CP) features in patients with bone metastasis and cancer-induced bone pain (CIBP) and the relationship between ECS-CP features, pain intensity, and opioid consumption. METHODS: We assessed ECS-CP features and recoded pain mechanisms and opioid use in adult patients with bone metastasis. Validated measures were used to assess pain intensity, incident pain, psychological distress, addictive behavior, and cognition. RESULTS: Among 147 eligible patients, 95.2% completed the assessment. Mean participant age was 73.2 years, the majority female (52.1%) with breast cancer occurring most commonly (25.7%). One or more ECS-CP features were present in 96.4% and CIBP in 75.7% of patients. The median average and worst pain scores were 3 and 6, respectively. Neuropathic pain was the most prevalent pain mechanism (45.0%) and was associated with breakthrough pain frequency (p=0.014). Three-quarters had incident pain, which was strongly associated with a higher average and worst pain scores (3.5 and 7, p<0.001 for both), background oral morphine equivalent daily dose (26.7mg, p=0.005), and frequency of daily breakthrough analgesia (1.7 doses/day, p=0.007). Psychological distress (n=90, 64.3%) was associated with a significantly higher average pain score (4, p=0.009) and a slightly higher worst pain score (7, p=0.054). Addictive behaviour and cognitive dysfunction were relatively uncommon (18.6% and 12.9%, respectively). CONCLUSION: There is a need to promote standardized assessment and classification of pain syndromes such as CIBP. The ECS-CP may allow us to consider CIBP in a systematic manner and develop personalized pain interventions appropriate to the pain profile. TRIAL REGISTRATION: Retrospectively registered in ANZCTR ACTRN12622000853741 (16/06/2022).

Patient-caregiver communication concordance in cancer-refinement of the Cancer Communication Assessment Tool in an Australian sample.

PURPOSE: The objective of this study was to expand the international psychometric validation of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) within a sample of Australian cancer patients. METHODS: Survey data from 181 cancer patient-caregiver dyads ≥ 18 years of age with solid or haematological cancers were analysed (85.4% response rate). Spearman's rho was used to examine the correlation between CCAT-P and CCAT-F scores and weighted kappa the agreement between them. Exploratory factor analysis using scree plot and Kaiser-Guttman criteria was conducted to evaluate the scale structure. Cronbach's α and Pearson correlation coefficients were used to measure internal consistency and concurrent validity respectively. RESULTS: Mean scores were the following: CCAT-P 46.2 (9.8), CCAT-F 45.7 (9.4), and CCAT-PF 24.1 (8.0). We confirmed the poor concordance between patient and caregiver reporting of items in the CCAT-PF, with all but two items having weighted kappa values < 0.20 and Spearman's rho < 0.19. We derived a three-factor solution, disclosure, limitation of treatment, and treatment decision making, with reliability ranging from Cronbach's α = 0.43-0.53. The CCAT-P and CCAT-F showed strong correlations with preparation for decision-making (CCAT-P: r = 0.0.92; CCATF: r = 0.0.93) but were weakly associated with patient/caregiver distress related with having difficult conversations on future care planning. CONCLUSION: Preliminary validation of the CCAT-PF in the Australian setting has shown some similar psychometric properties to previously published studies, further supporting its potential utility as a tool to assess patient-caregiver dyadic communication. TRIAL REGISTRATION: ACTRN12620001035910 12/10/2020 retrospectively registered.

Impact of ambulatory palliative care on symptoms and service outcomes in cancer patients: a retrospective cohort study.

BACKGROUND: The integration of palliative care into routine cancer care has allowed for improved symptom control, relationship building and goal setting for patients and families. This study aimed to assess the efficacy of an ambulatory palliative care clinic on improving symptom burden and service outcomes for patients with cancer. METHODS: A retrospective review of data of cancer patients who attended an ambulatory care clinic and completed the Symptom Assessment Scale between January 2015 and December 2019. We classified moderate to severe symptoms as clinically significant. Clinically meaningful improvement in symptoms (excluding pain) was defined by a ≥ 1-point reduction from baseline and pain treatment response was defined as a ≥ 2-point or ≥ 30% reduction from baseline. RESULTS: A total of 249 patients met the inclusion criteria. The most common cancer diagnosis was gastrointestinal (32%) and the median time between the initial and follow-up clinic was 4 weeks. The prevalence of clinically significant symptoms at baseline varied from 28% for nausea to 88% for fatigue, with 23% of the cohort requiring acute admission due to unstable physical/psychosocial symptoms. There was significant improvement noted in sleep (p < 0.001), pain (p = 0.002), wellbeing (p < 0.001), and overall symptom composite scores (p = 0.028). Despite 18-28% of patients achieving clinically meaningful symptom improvement, 18-66.3% of those with moderate to severe symptoms at baseline continued to have clinically significant symptoms on follow-up. A third of patients had opioid and/or adjuvant analgesic initiated/titrated, with 39% educated on pain management. Goals of care (31%), insight (28%) and psychosocial/existential issues (27%) were commonly explored. CONCLUSIONS: This study highlights the burden of symptoms in a cohort of ambulatory palliative care patients and the opportunity such services can provide for education, psychosocial care and future planning. Additionally routine screening of cohorts of oncology patients using validated scales may identify patients who would benefit from early ambulatory palliative care.

Patient-caregiver dyads advance care plan value discussions: randomised controlled cancer trial of video decision support tool.

OBJECTIVE: Uptake of advance care planning (ACP) in cancer remains low. An emphasis on personal value discussions and adoption of novel interventions may serve as the catalyst to increase engagement. This study examined the effectiveness of a video decision support tool (VDST) modelling values conversations in cancer ACP. METHODS: This single site, open-label, randomised controlled trial allocated patient-caregiver dyads on a 1:1 ratio to VDST or usual care (UC). Previously used written vignettes were converted to video vignettes using standard methodology. We evaluated ACP document completion rates, understanding and perspectives on ACP, congruence in communication and preparation for decision-making. RESULTS: Participants numbered 113 (60.4% response rate). The VDST did not improve overall ACP document completion (37.7% VDST; 36.7% UC). However, the VDST improved ACP document completion in older patients (≥70) compared with younger counterparts (<70) (OR=0.308, 95% CI 0.096 to 0.982, p=0.047), elicited greater distress in patients (p=0.015) and improved patients and caregivers ratings for opportunities to discuss ACP with health professionals. ACP improved concordance in communication (VDST p=0.006; UC p=0.045), more so with the VDST (effect size: VDST 0.7; UC 0.54). Concordance in communication also improved in both arms with age. CONCLUSION: The VDST failed to improve ACP document completion rates but highlighted that exploring core patient values may improve concordance in patient-caregiver communication. Striving towards a more rigorous design of the VDST intervention, incorporating clinical outcome scenarios with values conversations may be the catalyst needed to progress ACP towards a more fulfilling process for those who partake in it. TRIAL REGISTRATION NUMBER: ACTRN12620001035910.

Video decision support tool promoting values conversations in advanced care planning in cancer: protocol of a randomised controlled trial.

BACKGROUND: Views on advance care planning (ACP) has shifted from a focus solely on treatment decisions at the end-of-life and medically orientated advanced directives to encouraging conversations on personal values and life goals, patient-caregiver communication and decision making, and family preparation. This study will evaluate the potential utility of a video decision support tool (VDST) that models values-based ACP discussions between cancer patients and their nominated caregivers to enable patients and families to achieve shared-decisions when completing ACP's. METHODS: This open-label, parallel-arm, phase II randomised control trial will recruit cancer patient-caregiver dyads across a large health network. Previously used written vignettes will be converted to video vignettes using the recommended methodology. Participants will be ≥18 years and be able to complete questionnaires. Dyads will be randomised in a 1:1 ratio to a usual care (UC) or VDST group. The VDST group will watch a video of several patient-caregiver dyads communicating personal values across different cancer trajectory stages and will receive verbal and written ACP information. The UC group will receive verbal and written ACP information. Patient and caregiver data will be collected individually via an anonymous questionnaire developed for the study, pre and post the UC and VDST intervention. Our primary outcome will be ACP completion rates. Secondarily, we will compare patient-caregiver (i) attitudes towards ACP, (ii) congruence in communication, and (iii) preparation for decision-making. CONCLUSION: We need to continue to explore innovative ways to engage cancer patients in ACP. This study will be the first VDST study to attempt to integrate values-based conversations into an ACP intervention. This pilot study's findings will assist with further refinement of the VDST and planning for a future multisite study. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry No: ACTRN12620001035910 . Registered 12 October 2020. Retrospectively registered.

The role of methadone in cancer-induced bone pain: a retrospective cohort study.

PURPOSE: Cancer-induced bone pain (CIBP) can be challenging to manage in advanced cancer. The unique properties of methadone may have a role in refractory CIBP. We aimed to evaluate the analgesic effects of methadone for CIBP when other opioids are ineffective or intolerable. METHODS: A retrospective study of palliative care inpatients rotated to methadone from another opioid for CIBP over a 4-year period. Primary outcome was ≥ 30% reduction in pain intensity (11-point numeric rating scale) from baseline to completion of methadone rotation (MR). Secondary outcomes were ≥ 50% reduction in pain intensity and changes in long-acting and breakthrough opioid requirements. RESULTS: Ninety-four eligible patients completed MR for the following reasons: poor pain control (72.3%), opioid toxicities (4.3%) or both (23.4%). On completion of MR, 70.2% and 53.2% achieved a ≥ 30% and ≥ 50% reduction in pain respectively, with mean pain intensity score reduced from 5.6 (SD = 2.1) at baseline to 2.6 (SD = 2.5) (p < 0.001). Mean calculated daily methadone dose pre-MR was 25.7 mg (SD = 10.9), with 72.3% of patients requiring a lower dose on completion of MR (mean 17.0 mg, SD = 8.5). The mean number of breakthrough opioid analgesia used a day reduced from 3.4 (SD = 2.3) to 1.8 (SD = 1.7) (p < 0.001). CONCLUSIONS: MR for CIBP may result in reduction in pain intensity, when other opioids are ineffective or intolerable, with patients requiring reduced overall dosing of their long-acting opioid and frequency of breakthrough opioid use.

Propofol for palliative sedation.

Palliative sedation is the intentional use of sedatives to manage refractory symptom(s), such as pain and/or terminal restlessness. This case report describes the successful use of propofol, an ultra-fast-acting anaesthetic agent commonly used for anaesthesia induction and maintenance to manage refractory agitated delirium in an acute inpatient palliative medicine setting.

Meaning and Purpose (MaP) therapy II: Feasibility and acceptability from a pilot study in advanced cancer.

OBJECTIVE: Meaning and Purpose (MaP) therapy aims to enhance meaning-based coping through a life review that focuses on the value and worth of the person, key relationships, sources of fulfillment, roles, and future priorities in living life out fully. We sought to test the feasibility and acceptability of a six-session model of MaP therapy against a wait-list control cohort in a pilot study seeking effect sizes on measures of adaptation. METHOD: We randomized patients with advanced cancer to MaP therapy or wait-list control, with measures administered at baseline and after 6-8 weeks. Wait-list patients could then crossover to receive therapy, with further measures collected postintervention. Adherence to the manualized model was sustained through weekly supervision and fidelity coding of recorded sessions. We used generalized estimating equations to control for baseline and any correlation of data.ResultFrom 134 eligible participants, 57 (43%) consented, and 40 of 45 (89%) offered therapy completed 6 sessions. Key barriers to consenting patients were poor health (15 refusers and 4 withdrawals) and death intervened in 6 participants. MaP therapy generated adequate effect sizes in posttraumatic growth (new possibilities, appreciation of life, and personal strength) and life attitudes (choices and goal seeking) to permit calculation of power for a formal randomized, controlled trial.Significance of resultsDelivery of this model of existentially oriented therapy is feasible and acceptable to patients. A properly powered randomized controlled trial is justified to examine the efficacy of this intervention.

Refinement and revalidation of the demoralization scale: The DS-II-internal validity.

BACKGROUND: The Demoralization Scale (DS) was initially validated in 2004 to enable the measurement of demoralization in patients with advanced cancer. Subsequent shortcomings indicated the need for psychometric strengthening. Here, the authors report on the refinement and revalidation of the DS to form the DS-II, specifically reporting the scale's internal validity. METHODS: Patients with cancer or other progressive diseases who were receiving palliative care (n = 211) completed a revised version of the 24-item DS and a measure of symptom burden (the Memorial Symptom Assessment Scale). Exploratory factor analysis and Rasch modeling were used to evaluate, modify, and revalidate the scale, providing information about dimensionality, suitability of response format, item fit, item bias, and item difficulty. Test-retest reliability was examined for 58 symptomatically stable patients at a 5-day follow-up. RESULTS: Exploratory factor analysis supported a 22-item, 2-component model. Separate Rasch modeling of each component resulted in collapsing the response option categories and removing 3 items from each component. Both final 8-item subscales met Rasch model expectations and were appropriate to sum as a 16-item total score. The DS-II demonstrated internal consistency and test-retest reliability (Meaning and Purpose subscale: α = .84; intraclass correlation [ICC] = 0.68; Distress and Coping Ability subscale: α = .82; ICC = 0.82; total DS: α = .89; ICC = 0.80). CONCLUSIONS: The DS-II is a 3-point response, self-report scale comprising 16 items and 2 subscales. Given its revalidation, psychometric strengthening, and simplification, the DS-II is an improved and more practical measure of demoralization for research and clinical use. External validation of the DS-II will be reported subsequently. Cancer 2016;122:2251-9. © 2016 American Cancer Society.

Refinement and revalidation of the demoralization scale: The DS-II-external validity.

BACKGROUND: The recently refined Demoralization Scale-II (DS-II) is a 16-item, self-report measure of demoralization. Its 2 factors-Meaning and Purpose and Distress and Coping Ability-demonstrate sound internal validity, including item fit, unidimensionality, internal consistency, and test-retest reliability. The convergent and discriminant validity of the DS-II with various measures is reported here. METHODS: Patients who had cancer or other progressive diseases and were receiving palliative care (n = 211) completed a battery of questionnaires, including the DS-II and measures of symptom burden, quality of life, depression, and attitudes toward the end of life. Spearman ρ correlations were determined to assess convergent validity. Mann-Whitney U tests with calculated effect sizes were used to examine discriminant validity and establish the minimal clinically important difference (MCID). Cross-tabulation frequencies with chi-square analyses were used to examine discriminant validity with major depression. RESULTS: The DS-II demonstrated convergent validity with measures of psychological distress, quality of life, and attitudes toward the end of life. It also demonstrated discriminant validity, as the DS-II differentiated patients who had different functional performance levels and high/low symptoms, with a difference of 2 points between groups on the DS-II considered clinically meaningful. Furthermore, discriminant validity was demonstrated, as comorbidity with depression was not observed at moderate levels of demoralization. CONCLUSIONS: The DS-II has sound psychometric properties and is an appropriate measure of demoralization. Given its structural simplicity and brevity, it is likely to be a useful tool in meaning-centered therapies. Cancer 2016;122:2260-7. © 2016 American Cancer Society.

Hospital rapid response team and patients with life-limiting illness: a multicentre retrospective cohort study.

BACKGROUND: Approximately one-third of rapid response team consultations involve issues of end-of-life care. We postulate a greater occurrence in patients with a life-limiting illness, in whom the opportunity for advance care planning and palliative care involvement should be offered. AIMS: We aim to review the characteristics and compare outcomes of rapid response team consultations on patients with and without a life-limiting illness. DESIGN/SETTING: A 3-month retrospective cohort study of all rapid response team consultations was conducted. The sample population included all adult inpatients in a major teaching hospital network. RESULTS: We identified 351 patients - including 139 with a life-limiting illness - receiving a total of 456 rapid response team consultations. The median time from admission to the first rapid response team consultation was 3 days. Patients with a life-limiting illness had a significantly higher mortality rate (41.7% vs 13.2%), were older (72.6 vs 63.5 years), more likely to come from a residential aged-care facility (29.5% vs 4.1%) and had a shorter hospital stay (10 vs 13 days). Rapid response team consultations resulted in a change to more palliative goals of care in 28.5% of patients, of whom two-thirds had a life-limiting illness. CONCLUSION: Patients with a life-limiting illness had worse outcomes post-rapid response team consultation. Our findings suggest that a routine clarification of goals of care for this cohort, within 3 days of hospital admission, may be advantageous. These discussions may provide clarity of purpose to treating teams, reduce the burden of unnecessary interventions and promote patient-centred care agreed upon in advance of any deterioration.