Association of optimism and social support with health-related quality of life among Australian women cancer survivors - A cohort study.

AIM: Large-scale studies investigating health-related quality of life (HRQL) in cancer survivors are limited. This study aims to investigate HRQL and its relation to optimism and social support among Australian women following a cancer diagnosis. METHODS: Data were from the Australian Longitudinal Study on Women's Health, a large cohort study (n = 14,715; born 1946-51), with 1428 incident cancer cases ascertained 1996-2017 via linkage to the Australian Cancer Database. HRQL was measured using the Short Form-36 (median 1.7 years post-cancer-diagnosis). Multivariable linear regression was performed on each HRQL domain, separately for all cancers combined, major cancer sites, and cancer-free peers. RESULTS: Higher optimism and social support were significantly associated with better HRQL across various domains in women with and without a cancer diagnosis (p < 0.05). Mean HRQL scores across all domains for all cancer sites were significantly higher among optimistic versus not optimistic women with cancer (p < 0.05). Adjusting for sociodemographic and other health conditions, lower optimism was associated with reduced scores across all domains, with greater reductions in mental health (adjusted mean difference (AMD) = -11.54, p < 0.01) followed by general health (AMD = -11.08, p < 0.01). Social support was less consistently related to HRQL scores, and following adjustment was only significantly associated with social functioning (AMD = -7.22, p < 0.01) and mental health (AMD = -6.34, p < 0.01). CONCLUSIONS: Our findings highlight a strong connection between optimism, social support, and HRQL among cancer survivors. Providing psychosocial support and addressing behavioral and socioeconomic factors and other health conditions associated with optimism and social support may improve HRQL.

Experiences and perspectives of colorectal cancer survivors and general practitioners on the delivery of survivorship care in general practice: a mixed methods study.

BACKGROUND: Many colorectal cancer (CRC) survivors experience ongoing sequelae from their cancer treatment. Limited evidence exists regarding how CRC survivors and general practitioners (GPs) manage these sequelae in the community. This study aimed to explore the experiences and perspectives of CRC survivors and GPs on current approaches to monitoring and managing sequelae of CRC treatment. METHODS: We conducted a mixed-methods study using cross-sectional national surveys and qualitative interviews with CRC survivors and GPs to explore: (1) treatment sequelae experienced by CRC survivors, (2) how these were monitored and managed by general practitioners, and (3) suggestions to improve ongoing management of the treatment sequelae. Survey responses were reported descriptively. Qualitative data were thematically analysed using an interpretive descriptive approach. RESULTS: Seventy participants completed surveys: 51 CRC survivors and 19 GPs, and four interviews were conducted with GPs. CRC survivors experienced a range of treatment sequelae, but often did not discuss these with their GPs (experienced vs discussed: 86% vs 47% for fatigue/lack of energy, 78% vs 27% for psychological/emotional concern, 63% vs 22% for impaired sleep, 69% vs 29% for weight loss/gain, 59% vs 16% for sexual and intimacy concerns). GPs reported inadequate information transfer from cancer services and workload as major barriers to optimal care. CONCLUSIONS: System-level changes that facilitate adequate information transfer from cancer services to GPs upon CRC treatment completion, as well as addressing time constraint issues essential for comprehensive monitoring and management of CRC treatment sequelae, could enhance the care of CRC survivors in the community setting.

First Phase Development of a Patient-reported Outcome Measure for Midface Oncology.

Background: Facial cancer surgery involving the midface (comprising the lower eyelids, nose, cheeks, and upper lip) can have debilitating life-changing functional, social, and psychological impacts on the patient. Midface symptoms are inadequately captured by existing patient-reported outcome measures (PROMs). PROMs are increasingly used for individual patient care, quality improvement, and standardized reporting of treatment outcomes. This study aimed to present our findings from the first phase of the development of a midface, specifically periocular and nasal, PROM. Methods: After international guidance for PROM development, the first phase comprised identification of salient issues and item generation. Fifteen patients who had midface surgery and 10 clinicians from various specialties with more than 5 years' experience treating these patients were recruited. Semi-structured interviews explored aesthetic, functional, social, and psychological outcomes, with specific attention to deficiencies in current PROMs. Thematic analysis was used to develop an item pool, and group interviews with clinicians were carried out to create and refine PROM scales. Results: Qualitative data from patient interviews were grouped into aesthetic, functional, and psychosocial domains for the eyelids and nose. Ninety-nine draft items were generated across these domains. Following focus group discussions, the final version of the midface-specific PROM contained 31 items (13 eye-specific, 10-nose-specific, eight general midface items). Conclusions: This midface-specific PROM is valuable in assessing and comparing patient-reported outcomes in those who have undergone complex resection and reconstruction of the midface. This PROM is currently undergoing field testing.

The use of patient reported outcome measures in oncology clinical practice across Australia and New Zealand.

BACKGROUND: While there is increasing evidence on the benefits of PROMs in cancer care, the extent of routine collection and use of PROMs in clinical cancer practice across Australia and New Zealand (ANZ) is unknown. This study examined the prevalence and characteristics of PROMs use in routine clinical cancer care in ANZ. METHODS: An online survey was designed and disseminated via professional societies and organisations using a snowball sampling approach to clinical and health administration professionals managing cancer care in ANZ. A poster advertising the study was also circulated on professional social media networks via LinkedIn and Twitter inviting health professionals from ANZ to participate if they were using or intending to use PROMs in clinical cancer practice. Responders opted into the survey via the survey link. RESULTS: From 132 survey views, 91(response rate, 69%) respondents from 56 clinical practices across ANZ agreed to participate in the survey, and of these 55 (n = 55/91, 60%) respondents reported collecting PROMs within their clinical practice. The majority of the respondents were from the State of New South Wales in Australia (n = 21/55, 38%), hospital (n = 35/55, 64%), and a public setting (n = 46/55, 83%). PROMs were collected in all cancer types (n = 21/36, 58%), in all stages of the disease (n = 31/36, 86%), in an adult population (n = 33/36, 92%), applied in English (n = 33/36, 92%), and used to facilitate communication with other reasons (27/36, 75%). A geospatial map analysis provided insights into the variation in PROMs uptake between the two countries and in certain jurisdictions within Australia. This study also highlights the limited resources for PROMs implementation, and a lack of systematic priority driven approach. CONCLUSION: PROM use across Australia and New Zealand seems variable and occurring predominantly in larger metropolitan centres with limited standardisation of approach and implementation. A greater focus on equitable adoption of PROMs in diverse cancer care settings is urgently needed.

Using Implementation Science Frameworks to Guide the Use of Electronic Patient-Reported Outcome Symptom Monitoring in Routine Cancer Care.

PURPOSE: Electronic patient-reported outcomes (ePROs) are an evidence-based means of detecting symptoms earlier and improving patient outcomes. However, there are few examples of successful implementation in routine cancer care. We conducted a qualitative study to identify barriers and facilitators to implementing ePRO symptom monitoring in routine cancer care using the Consolidated Framework for Implementation Research (CFIR). METHODS: Participants were adult patients with cancer, their caregivers, or health care professionals involved in ePRO monitoring or processes. Focus groups or individual interviews were conducted using a semistructured approach informed by the CFIR. Data were analyzed deductively using the CFIR. Barriers were matched to theory-informed implementation strategies using the CFIR-Expert Recommendations for Implementing Change (ERIC) matching tool. RESULTS: Thirty participants were interviewed: 22 females (73%), aged 31-70 years (28, 94%), comprising patients (n = 8), caregivers (n = 2), medical oncologists (n = 4), nurses (n = 4), hospital leaders (n = 6), clinic administrators (n = 2), pharmacists (n = 2), and information technology specialists (n = 2). Barriers pertaining to four CFIR domains were identified and several were novel, including the challenge of adapting ePROs for different anticancer treatments. Facilitators pertaining to all CFIR domains were identified, such as leveraging acceptability of remote care post-COVID-19 to drive implementation. Conducting consensus discussions with stakeholders to tailor ePROs to the local setting, identifying/preparing individual and group-level champions, and assessing readiness for change (including leveraging technological advances and increased confidence in using remote monitoring post-COVID-19) were the most frequently recommended implementation strategies. CONCLUSION: The CFIR facilitated identification of known and novel barriers and facilitators to implementing ePRO symptom monitoring in routine cancer care. Implementation strategies summarized in a conceptual framework will be used to codesign an ePRO symptom monitoring system for immunotherapy side effects.

Development and implementation barriers of a new patient-reported measure: The Radiation therapy-related Inconvenience Questionnaire (RIQ).

INTRODUCTION: Radiation therapy (RT) can benefit approximately 50% of cancer patients and contribute to 40% of all cancer cures, yet its utilisation in cancer is low globally. Several factors contribute to this including perceived inconvenience related to accessing and utilising RT. To quantitatively assess the latter, a new tool - the Radiation therapy-related Inconvenience Questionnaire (RIQ) - was developed. This study aimed to pre-test the RIQ and explore barriers and facilitators to implementing it in routine clinical practice and clinical trials. METHODS: Semi-structured cognitive interviews were conducted with patients undertaking RT, recruited via three hospitals to examine content validity, acceptability, and comprehensibility of the RIQ. Interviews identified inconsistencies, relevance, and clarity of items. Semi-structured interviews with healthcare professionals involved in the delivery of care to individuals undertaking RT explored barriers and facilitators to routine usage. Thematic analysis was used to identify themes. RESULTS: Patients (N = 15) identified problems in content, instructions, layout, length, and response options; consequently, 25 items were revised and eight removed, resulting in a final 29-item questionnaire. Clinicians identified staff- and patient-specific barriers to implementing RIQ in clinical practice. Perceived facilitators included the following: (a) workplace factors, (b) mode of administration, and (c) imparting knowledge. CONCLUSION: This study demonstrated acceptability and comprehensibility of the 29-item RIQ amongst cancer patients undertaking RT and treating clinicians. The next phase will evaluate the RIQ's measurement properties in a larger clinical study. The barriers and facilitators identified can guide future implementation of RIQ in clinical practice and clinical trials.

Health-related quality of life in patients accessing medicinal cannabis in Australia: The QUEST initiative results of a 3-month follow-up observational study.

AIMS: Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal cannabis. We hypothesized that all patient-reported outcomes (PROs) would improve from baseline to 3-months. METHODS: The QUEST Initiative is a large prospective multicenter study of patients with any chronic health condition newly prescribed medicinal cannabis between November 2020 and December 2021. Eligible patients were identified by 120 clinicians at medical centers across six Australian states. Consenting participants completed the EuroQol Group EQ-5D-5L health status questionnaire; European Organization for Research & Treatment of Cancer Quality of Life questionnaire (QLQ-C30); Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms in Fatigue and Sleep Disturbance, and the Depression Anxiety Stress Scale (DASS-21) before starting therapy, at 2-weeks titration, then monthly for 3-months. RESULTS: Of the 2762 consenting participants, 2327 completed baseline and at least one follow-up questionnaire. Ages ranged between 18-97 years (mean 51y; SD = 15.4), 62.8% were female. The most commonly treated conditions were chronic pain (n = 1598/2327; 68.7%), insomnia (n = 534/2327; 22.9%), generalized anxiety (n = 508/2327; 21.5%), and mixed anxiety and depression (n = 259/2327; 11%). Across the whole cohort both EQ-5D-5L utility scores and QLQ-C30 summary scores showed clinically meaningful improvement in HRQL from baseline to mean follow-up with d = 0.54 (95%CI:0.47 to 0.59) and d = 0.64 (95%CI:0.58 to 0.70) respectively; and clinically meaningful improvement in fatigue (d = 0.54; 95%CI:0.48 to 0.59). There was clinically meaningful reduction of pain for those with chronic pain (d = 0.65; 95%CI:0.57 to 0.72); significant improvements for those with moderate to extremely severe anxiety (X2 = 383; df = 4; p<0.001) and depression (X2 = 395; df = 4; p<0.001); and no changes in sleep disturbance. CONCLUSIONS: We observed statistically significant, clinically meaningful improvements in overall HRQL and fatigue over the first 3-months in patients with chronic health conditions accessing prescribed medical cannabis. Anxiety, depression, and pain also improved over time, particularly for those with corresponding health conditions. The study continues to follow-up patients until 12-months to determine whether improvements in PROs are maintained long-term. TRAIL REGISTRATION: Study registration - Australian New Zealand Clinical Trials Registry: ACTRN12621000063819. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000063819.

Women's views about current and future management of Ductal Carcinoma in Situ (DCIS): A mixed-methods study.

Management of low-risk ductal carcinoma in situ (DCIS) is controversial, with clinical trials currently assessing the safety of active monitoring amidst concern about overtreatment. Little is known about general community views regarding DCIS and its management. We aimed to explore women's understanding and views about low-risk DCIS and current and potential future management options. This mixed-method study involved qualitative focus groups and brief quantitative questionnaires. Participants were screening-aged (50-74 years) women, with diverse socioeconomic backgrounds and no personal history of breast cancer/DCIS, recruited from across metropolitan Sydney, Australia. Sessions incorporated an informative presentation interspersed with group discussions which were audio-recorded, transcribed and analysed thematically. Fifty-six women took part in six age-stratified focus groups. Prior awareness of DCIS was limited, however women developed reasonable understanding of DCIS and the relevant issues. Overall, women expressed substantial support for active monitoring being offered as a management approach for low-risk DCIS, and many were interested in participating in a hypothetical clinical trial. Although some women expressed concern that current management may sometimes represent overtreatment, there were mixed views about personally accepting monitoring. Women noted a number of important questions and considerations that would factor into their decision making. Our findings about women's perceptions of active monitoring for DCIS are timely while results of ongoing clinical trials of monitoring are awaited, and may inform clinicians and investigators designing future, similar trials. Exploration of offering well-informed patients the choice of non-surgical management of low-risk DCIS, even outside a clinical trial setting, may be warranted.

Supportive care interventions for managing gastrointestinal symptoms following treatment for colorectal cancer: a systematic review.

INTRODUCTION: Colorectal cancer (CRC) is prevalent in the developed world, with unhealthy lifestyles and diet contributing to rising incidence. Advances in effective screening, diagnosis, and treatments have led to improved survival rates, but CRC survivors suffer poorer long-term gastrointestinal consequences than the general population. However, the current state of clinical practice around provision of health services and treatment options remains unclear. PURPOSE: We aimed to identify what supportive care interventions are available to manage gastrointestinal (GI) symptoms for CRC survivors. METHODS: We searched Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycINFO, and CINAHL from 2000 to April 2022 for resources, services, programs, or interventions to address GI symptoms and functional outcomes in CRC. We extracted information about characteristics of supportive care interventions, the study design, and sample characteristics from included studies, and performed a narrative synthesis RESULTS: Of 3807 papers retrieved, seven met the eligibility criteria. Types of interventions for managing or improving GI symptoms included two rehabilitation, one exercise, one educational, one dietary, and one pharmacological. Pelvic floor muscle exercise may help to resolve GI symptoms more quickly in the post-operative recovery phase. Survivors may also benefit from rehabilitation programs through improved self-management strategies, especially administered soon after completing primary treatment. CONCLUSIONS/IMPLICATIONS FOR CANCER SURVIVORS: Despite a high prevalence and burden of GI symptoms post-treatment, there is limited evidence for supportive care interventions to help manage or alleviate these symptoms. More, large-scale randomized controlled trials are needed to identify effective interventions for managing GI symptoms that occur post-treatment.

Development of consensus-based considerations for use of adult proxy reporting: an ISOQOL task force initiative.

AIMS: Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, including who can serve as a proxy, and considerations for data collection, analysis, and reporting. The primary objective of this work by the ISOQOL Proxy Task Force was to review documents and clinical outcome assessment measures with respect to proxy reporting and to develop, through consensus, considerations for proxy reporting. METHODS: We assembled an international group with clinically relevant and/or methodological expertise on proxy use in adult populations. We conducted a targeted review of documentation based on regulatory, non-regulatory, professional society, and individual measure sources. Using a standardized collection form, proxy-related information was extracted from each source including definitions of a proxy, characteristics of a proxy, domains addressable or addressed by a proxy, and observer-reporting. RESULTS: The definition of proxy was inconsistent across 39 sources, except regulatory documents which defined a proxy as a person other than the patient who reports on an outcome as if she/he were the patient. While proxy report was discouraged in regulatory documentation, it was acknowledged there were instances where self-report was impossible. Many documentation sources indicated proxies would be well-justified in certain contexts, but did not indicate who could act as a proxy, when proxies could be used, what domains of patient health they could report on, or how data should be reported. Observer-reported outcomes were typically defined as those based on observed behaviors, however there was not a consistent differentiation between proxy and observer reporting. Based on information extracted from these resources, we developed a checklist of considerations when including proxy-reported measures or using proxies in study design, data collection, analysis, interpretation and reporting of proxy reported data. CONCLUSION: Our targeted review highlights a lack of clarity in capturing, interpreting and reporting data from proxies in adult populations. We provide a checklist of considerations to assist researchers and clinicians with including proxies in research studies and clinical care. Lastly, our review identified areas where further guidance and future research are necessary.

The Feasibility, Acceptability, and Effectiveness of Electronic Patient-Reported Outcome Symptom Monitoring for Immune Checkpoint Inhibitor Toxicities: A Systematic Review.

PURPOSE: Increasing use of immune checkpoint inhibitors (ICIs) in routine cancer care will increase the incidence of immune-related adverse events (irAEs). Systems are needed to support remote monitoring for irAEs. Electronic patient-reported outcome (ePRO) symptom monitoring systems can help monitor and manage symptoms and side effects. We assessed the content and features of ePRO symptom monitoring systems for irAEs, and their feasibility, acceptability, and impact on patient outcomes and health care utilization. METHODS: A systematic literature search was conducted in May 2022 on MEDLINE, Embase, PsycINFO, and Cochrane Central Register of Controlled Trials. Quantitative and qualitative data relevant to the review questions were extracted and synthesized in tables. RESULTS: Seven papers describing five ePRO systems were included. All systems collected PROs between clinic visits. Two of five used validated symptom questionnaires, 3/5 provided prompts to complete questionnaires, 4/5 provided reminders to self-report, and 3/5 provided clinician alerts for severe/worsening side effects. Four of five provided coverage of ≥26/30 irAEs in the ASCO irAE guideline. Feasibility and acceptability were demonstrated with consent rates of 54%-100%, 17%-27% of questionnaires generating alerts, and adherence rates of 74%-75%. One paper showed a reduction in grade 3-4 irAEs, treatment discontinuation, clinic visit duration, and emergency department presentations, while another showed no difference in these outcomes or the rate of steroid use. CONCLUSION: There is preliminary evidence of the feasibility and acceptability of ePRO symptom monitoring for irAEs. However, further studies are needed to confirm the impact on ICI-specific outcomes, such as the frequency of grade 3-4 irAEs and duration of immunosuppression. Suggestions for the content and features of future ePRO systems for irAEs are provided.

[Spanish translation and cross-cultural adaptation of the Pressure Ulcer Quality of Life Questionnaire (PU-QOL).] / Traducción y adaptación transcultural al español del cuestionario de calidad de vida y úlceras por presión PU-QOL.

OBJECTIVE: Pressure ulcers (PU) are the most prevalent of the dependency-related injuries, affecting the quality of life of the patients who suffer them. However, there are no instruments adapted to the Spanish context to evaluate this quality of life. The use of specific tools in Spanish to evaluate the quality of life perceived by patients with PUs is considered an indispensable element for healthcare decisions. The aim of this paper was to translate and culturally adapt the Pressure Ulcer Quality of Life Questionnaire (PU-QOL) into Spanish for the measurement of health-related quality of life in patients with pressure ulcers. METHODS: A translation, back-translation, and pre-test method was used on the target population to obtain an adapted version of the original PU-QOL instrument. The area was Primary Care. The participants were fifteen Primary Care patients. Main steps: 1) Direct translation; 2) Synthesis and concordance of versions by an expert committee; 3) Back translation; 4) Consistency of the back translation with the author from the original questionnaire; and 5) Analysis of comprehensibility through cognitive interviews with a sample of patients. RESULTS: An instrument to measure perceived quality of life in patients with PU was obtained, composed of ten scales and eighty-three items. The scales and items of the original questionnaire were maintained. Conceptual and semantic analysis produced adjustments in wording, clarification and reformulations adapted to the Spanish context. CONCLUSIONS: We present this first phase of translation and cross-cultural adaptation of the PU-QOL questionnaire in Spanish, which could be a useful tool for decision-making on health care in patients with PUs.

OBJETIVO: Las úlceras por presión (UPP) son las lesiones más frecuentes de las relacionadas con la dependencia y tienen un gran impacto en la calidad de vida de quienes las sufren. Disponer de herramientas en español específicas para evaluar la calidad de vida percibida por los pacientes con UPP se considera un elemento indispensable para la toma de decisiones sobre los cuidados de salud. El objetivo de este estudio fue traducir al español y adaptar culturalmente el cuestionario Pressure Ulcer Quality of Life Questionnaire (PU-QOL) para la medición de la calidad de vida relacionada con la salud en pacientes con úlceras por presión. METODOS: Se utilizó un método de traducción, retrotraducción y pretest a la población diana para obtener una versión adaptada del instrumento original PU-QOL. El emplazamiento fue la Atención Primaria. Los participantes fueron quince pacientes de Atención Primaria. Mediciones principales: 1) Traducción directa; 2) Síntesis y conciliación de las versiones por un comité de expertos; 3) Traducción inversa; 4) Conciliación de la traducción inversa con la autora del cuestionario original; y 5) Análisis de la comprensibilidad mediante entrevistas cognitivas a una muestra de pacientes. RESULTADOS: Se obtuvo un instrumento de medición de calidad de vida percibida en pacientes con UPP, compuesto por diez escalas y ochenta y tres ítems. Se mantuvieron las escalas e ítems del cuestionario original. El análisis conceptual y semántico produjo ajustes de redacción, clarificación y reformulaciones adaptadas al contexto español. CONCLUSIONES: La disponibilidad de un cuestionario en español de medición de calidad de vida percibida, como es el PU-QOL, del que presentamos esta primera fase de traducción y adaptación transcultural, podrá ser un elemento útil para la toma de decisiones sobre los cuidados en salud en pacientes con UPP.

How consequences of colorectal cancer treatment are managed: a qualitative study of stakeholder experiences about supportive care and current practices.

PURPOSE: Colorectal cancer (CRC) survivors experience treatment-effects such as symptoms and functional impairments. There is limited evidence about how these are managed and what services or supports are available in the community. We aimed to identify current practice and available supports for managing consequences of treatment from clinician and CRC survivor perspectives. METHODS: This qualitative study, informed by an interpretivist constructionist paradigm, included semi-structured interviews. Clinicians with experience of treating CRC patients and adult CRC survivors were recruited across Australia. Interviews explored experiences about problems experienced after CRC treatment and how these were managed. Data collection and analysis, using thematic analysis, was iterative whereby emergent themes during analysis were incorporated into subsequent interviews. RESULTS: We interviewed 16 clinicians and 18 survivors. Survivors experienced a range of consequences of treatment amendable to support including allied health, information, and self-management. Barriers to support access included clinicians' worry about patient out-of-pocket expenses, long waitlists, lack of awareness about existing supports, and perception no therapeutic options were available. Healthcare professionals with expertise in CRC were often difficult to identify outside of cancer settings. Survivorship care could be improved with individualised timely information and identification of pathways to access healthcare providers with expertise in managing consequences of CRC treatment within primary care. CONCLUSIONS: To improve CRC survivor lives posttreatment, routine assessment of consequences of treatment, individualised care planning involving relevant healthcare professionals, access to supportive care when needed, and improved information provision and engagement of a range of health professionals in follow-up care are needed.

Experiences of colorectal cancer survivors in returning to primary coordinated healthcare following treatment.

BACKGROUND: Advances in screening and treatments for colorectal cancer (CRC) have improved survival rates, leading to a large population of CRC survivors. Treatment for CRC can cause long-term side-effects and functioning impairments. General practitioners (GPs) have a role in meeting survivorship care needs of this group of survivors. We explored CRC survivors' experiences of managing the consequences of treatment in the community and their perspective on the GP's role in post-treatment care. METHODS: This was a qualitative study using an interpretive descriptive approach. Adult participants no longer actively receiving treatment for CRC were asked about: side-effects post-treatment; experiences of GP-coordinated care; perceived care gaps; and perceived GP role in post-treatment care. Thematic analysis was used for data analysis. RESULTS: A total of 19 interviews were conducted. Participants experienced side-effects that significantly impacted their lives; many they felt ill-prepared for. Disappointment and frustration was expressed with the healthcare system when expectations about preparation for post-treatment effects were not met. The GP was considered vital in survivorship care. Participants' unmet needs led to self-management, self-directed information seeking and sourcing referral options, leaving them feeling like their own care coordinator. Disparities in post-treatment care between metropolitan and rural participants were observed. CONCLUSION: There is a need for improved discharge preparation and information for GPs, and earlier recognition of concerns following CRC treatment to ensure timely management and access to services in the community, supported by system-level initiatives and appropriate interventions.

Impact of immune checkpoint inhibitors and targeted therapy on health-related quality of life of people with stage III and IV melanoma: a mixed-methods systematic review.

BACKGROUND: Immune checkpoint inhibitors (ICI) and targeted therapies (TT) have significantly improved disease control and survival in people with stage III and IV cutaneous melanoma. Understanding the impact of therapy on health-related quality of life (HRQL) is vital for treatment decision-making and determining targets for supportive care intervention. We conducted a mixed-methods systematic review to synthesise the impact of ICIs and TT on all domains of HRQL in these populations. METHODS: A systematic literature search was conducted in April 2022 on MEDLINE, PsycINFO, Embase and the Cochrane Central Register of Controlled Trials. Quantitative and qualitative data relevant to the review question were extracted and synthesised in tables according to setting (adjuvant versus metastatic), treatment type (ICI versus TT) and HRQL issue. RESULTS: Twenty-eight papers describing 27 studies were included: 15 randomised controlled trials (RCTs), four cohort studies, four single arm cross-sectional studies, two qualitative studies, one case control study and one mixed-methods study. In four studies of people with resected stage III melanoma, adjuvant pembrolizumab and dabrafenib-trametinib did not clinically or statistically change HRQL compared to baseline. In 17 studies of people with unresectable stage III/IV melanoma, inconsistencies in the impact of ICI on symptoms, functioning and overall HRQL were noted across different study designs. TT was associated with improvements in symptoms, functioning and HRQL across six studies. CONCLUSION: This review highlights the key physical, psychological and social issues experienced by people with stage III and IV melanoma treated with ICI and TT. Inconsistencies in the impact of ICI on HRQL were observed in different study designs. This highlights the need for treatment-specific patient-reported outcome measures for determining the impact of these therapies on HRQL and real-world data to inform treatment decision-making and appropriate supportive care interventions.

Patient-Reported Outcome Measures in Chemotherapy-Induced Peripheral Neurotoxicity: Defining Minimal and Clinically Important Changes.

BACKGROUND: Chemotherapy-induced peripheral neurotoxicity (CIPN) is a common complication of cancer treatment that produces functional disability. Increasingly, patient-reported outcome measures (PROMs) are used to assess CIPN, providing a broader symptom perspective than clinician-graded scales. Understanding when a reported change in CIPN symptoms meets the threshold for clinical significance is challenging. This study aimed to provide interpretation guidelines for validated CIPN PROMs, and thereby enable estimation of thresholds to identify clinically relevant symptoms. METHODS: Patients commencing neurotoxic cancer treatments were assessed at 3 timepoints: baseline, midtreatment, and end-of-treatment. Trajectory of CIPN development was assessed by means of CIPN PROMs, EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy questionnaire (QLQ-CIPN20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity questionnaire (FACT/GOG-NTX). Thresholds were estimated for CIPN PROMs using the NCI CTCAE sensory neuropathy scale as the clinical anchor by midtreatment and end-of-treatment. Patients were assigned to a clinical change group according to CIPN development: either no development; grade 1 neuropathy (minimally important difference [MID]); or grade 2 neuropathy (clinically important difference). Distribution-based estimates (SD, 0.5) were also evaluated as supportive evidence. RESULTS: In total, 406 patients were recruited to the study, of whom 62% (n=199/320) developed CIPN by midtreatment and 80% (n=274/343) by end-of-treatment. Anchor-based MID estimates by midtreatment were 5.06 (95% CI, 4.26-5.86) for the QLQ-CIPN20 and 3.54 (95% CI, 2.87-4.20) for the FACT/GOG-NTX. End-of-treatment MIDs were estimated to be 7.32 (95% CI, 6.23-8.40) for the QLQ-CIPN20 and 4.84 (95% CI, 3.98-5.70) for the FACT/GOG-NTX. Distribution-based MID estimations yielded lower values than anchor-based methods, at 3.73 for the QLQ-CIPN20 and 2.64 for the FACT/GOG-NTX at midtreatment and 5.52 for the QLQ-CIPN20 and 3.64 for the FACT/GOG-NTX at end-of-treatment. CONCLUSIONS: Findings from the present series aid meaningful interpretation for commonly used validated CIPN PROMs and provide thresholds that serve as guidance on how to interpret score changes, which will be useful for design and evaluation of clinical trials and clinical practice.

Patient and healthcare provider perceptions on using patient-reported experience measures (PREMs) in routine clinical care: a systematic review of qualitative studies.

BACKGROUND: Patient-reported experience measures (PREMs) assess quality-of-care from patients' perspectives. PREMs can be used to enhance patient-centered care and facilitate patient engagement in care. With increasing quality improvement studies in clinical practice, the use of PREMs has surged. As a result, knowledge about stakeholder experiences of using PREMs to assess quality of care across diverse clinical settings is needed to inform PREM implementation efforts. To address this, this review examines the qualitative literature on patient and healthcare provider experiences of using PREMs in clinical practice. METHODS: Medline, Embase and PsycInfo were systematically searched from inception to May 2021. Additional searching of reference lists for all included articles and relevant review articles were performed. Retrieved articles were screened for eligibility by one reviewer and 25% cross-checked by a second reviewer across all stages of the review. Full texts meeting eligibility criteria were appraised against the COREQ checklist for quality assessment and thematic analysis was used to analyze textual data extracted from the results. RESULTS: Electronic searches identified 2683 records, of which 20 studies met eligibility criteria. Extracted data were synthesized into six themes: facilitators to PREM implementation; barriers to PREM implementation; healthcare providers' perspectives towards using PREMs; patients' perspectives towards using PREMs; advantages of using PREMs in clinical practice; limitations and practical considerations to reduce resistance of PREM usage. The primary factors facilitating and impeding the use of PREMs include organizational-, staff- and patient-related factors. CONCLUSION: Results can be used to guide the usage and implementation of PREMs in clinical settings by addressing the identified barriers and building on the perceived benefits to encourage adoption of PREMs. Results around facilitators to PREM implementation and practical considerations could also promote appropriate use of PREMs by healthcare providers, helping to improve practice and the quality of care based on patient feedback.

Body Image Scale: Evaluation of the Psychometric Properties in Three Indian Head and Neck Cancer Language Groups.

Background: Body image is a subjective concept encompassing a person's views and emotions about their body. Head and neck cancer (HNC) diagnosis and treatment affects several psychosocial concepts including body image. Large numbers of HNC patients are diagnosed each year in India but there are no suitable measures in regional languages to assess their body image. This study assessed the psychometric properties of the Body Image Scale (BIS), a measure suitable for clinical and research use in HNC populations, translated into Tamil, Telugu and Hindi and compared body image distress between language groups. Methods: Translated versions of BIS were completed by HNC patients recruited from three cancer centers across India one time only. Psychometric evaluation was conducted including factor analysis using principal component analysis and internal consistency reliability using Cronbach's alpha. Patients completed the EORTC Quality of Life Questionnaire (QLQ) C-30 and EORTC QLQ HN-35 measures to enable exploration of convergent and discriminant validity. ANOVA was used to calculate difference in mean values for body image. Results: Our sample included 621 HNC patients (Tamil = 205, Telugu = 216, Hindi = 200). Factor analysis revealed a one-factor solution and Cronbach's alpha coefficients ranged between 0.891 and 0.969 indicating good reliability. Hypothesized correlations between similar and different constructs were as expected, supporting construct validity. On the BIS, we found a statistically significant difference (F = 11.0954, P < 0.05) between means of Tamil, Telugu, and Hindi groups, with higher body image scores in Telugu (M = 12.86; SD = 7.65) and Hindi groups (M = 12.52; SD = 7.36) indicating more symptoms/body image distress, when compared to Tamil population (M = 9.28; SD = 10.04). Conclusion: The reliability and validity of the three translated Indian versions of the BIS were maintained, providing a method for assessing body image of HNC population worldwide speaking Tamil, Telugu, and Hindi across the illness trajectory.