Objective Head and neck cancer (HNC) patients commonly undergo radiation therapy requiring immobilisation by a mask. Some find the mask distressing, and this can disrupt treatment sessions. This study aimed to explore the patient experience of immobilisation masks in the Australian and New Zealand (ANZ) context, to guide possible intervention. Methods Semi‐structured interviews were conducted with HNC patients who had completed radiation therapy, recruited via hospitals and social media. Interviews continued until data saturation; then, three further interviews were conducted for member‐checking purposes. Qualitative methodology with thematic analysis was used to identify themes in the data. Results Twenty HNC survivors participated in interviews, and seven themes were identified: information received by participants, potential predictors of mask anxiety, participant reactions to the mask, trajectories of mask anxiety, supportive behaviour and communication of health professionals, coping with the mask, and thoughts and feelings about the mask. Conclusions Participant experiences of the immobilisation mask were diverse. The findings fit with Lazarus and Folkman's (Stress, appraisal, and coping. New York, NY: Springer Pub. Co) transactional model of stress and coping, as participants appeared to make cognitive appraisals of the mask and their coping abilities throughout treatment, resulting in varied levels of mask‐related distress. Complex intervention is recommended to reduce mask anxiety in HNC patients across ANZ.
Background Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one’s treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA’s potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored. Methods The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months’ post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes). Results Intervention participants endorsed the e-DA as acceptable and feasible to use (82.1–94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA’s potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (− 0.69, 95% CIs − 1.04, − 0.33 at T1; and − 0.57, 95% CIs − 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (− 0.44, 95% CIs − 0.81, − 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety. Conclusion The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients’ decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017).
ObjectiveInformal family caregivers play a crucial role in cancer care. Effective caregiver involvement in cancer care can improve both patient and caregiver outcomes. Despite this, interventions improving the caregiver involvement are sparse. This protocol describes a randomised controlled trial evaluating the combined effectiveness of novel online caregiver communication education modules for: (1) oncology clinicians (eTRIO) and (2) patients with cancer and caregivers (eTRIO-pc).Methods and analysisThirty medical/radiation/surgical oncology or haematology doctors and nurses will be randomly allocated to either intervention (eTRIO) or control (an Australian State Government Health website on caregivers) education conditions. Following completion of education, each clinician will recruit nine patient–caregiver pairs, who will be allocated to the same condition as their recruiting clinician. Eligibility includes any new adult patient diagnosed with any type/stage cancer attending consultations with a caregiver. Approximately 270 patient–caregiver pairs will be recruited. The primary outcome is caregiver self-efficacy in triadic (clinician–patient–caregiver) communication. Patient and clinician self-efficacy in triadic communication are secondary outcomes. Additional secondary outcomes for clinicians include preferences for caregiver involvement, perceived module usability/acceptability, analysis of module use, satisfaction with the module, knowledge of strategies and feedback interviews. Secondary outcomes for caregivers and patients include preferences for caregiver involvement, satisfaction with clinician communication, distress, quality of life, healthcare expenditure, perceived module usability/acceptability and analysis of module use. A subset of patients and caregivers will complete feedback interviews. Secondary outcomes for caregivers include preparedness for caregiving, patient–caregiver communication and caring experience. Assessments will be conducted at baseline, and 1 week, 12 weeks and 26 weeks post-intervention.Ethics and disseminationEthical approval has been received by the Sydney Local Health District Human Research Ethics Committee (REGIS project ID number: 2019/PID09787), with site-specific approval from each recruitment site. Protocol V.7 (dated 1 September 2020) is currently approved and reported in this manuscript. Findings will be disseminated via presentations and peer-reviewed publications. Engagement with clinicians, media, government, consumers and peak cancer groups will facilitate widespread dissemination and long-term availability of the educational modules.Trial registration numberACTRN12619001507178.
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