Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET.

BACKGROUND: Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. METHODS: This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. DISCUSSION: This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

Patient-reported symptom monitoring: using (big) data to improve supportive care at the macro-, meso-, and micro-levels.

PURPOSE: This paper aims to provide a comprehensive understanding of the need for continued development of symptom monitoring (SM) implementation, utilization, and data usage at the macro-, meso-, and micro-levels. METHODS: Discussions from a patient-reported SM workshop at the MASCC/ISSO 2022 annual meeting were analyzed using a macro-meso-micro analytical framework of cancer care delivery. The workshop categories "initiation and implementation, barriers to adoption and utilization, and data usage" were integrated for each level. RESULTS: At the macro-level, policy development could encourage data sharing and international collaboration, including the exchange of SM methods, supportive care models, and self-management modules. At the meso-level, institutions should adjust clinical workflow and service delivery and promote a thorough technical and clinical integration of SM. At the micro-level, SM should be individualized, with timely feedback for patients, and should foster trust and understanding of AI decision support tools amongst clinicians to improve supportive care. CONCLUSIONS: The workshop reached a consensus among international experts on providing guidance on SM implementation, utilization, and (big) data usage pathways in cancer survivors across the cancer continuum and on macro-meso-micro levels.

Improved models of care for cancer survivors.

The number of survivors of cancer is increasing substantially. Current models of care are unsustainable and fail to address the many unmet needs of survivors of cancer. Numerous trials have investigated alternate models of care, including models led by primary-care providers, care shared between oncology specialists and primary-care providers, and care led by oncology nurses. These alternate models appear to be at least as effective as specialist-led care and are applicable to many survivors of cancer. Choosing the most appropriate care model for each patient depends on patient-level factors (such as risk of longer-term effects, late effects, individual desire, and capacity to self-manage), local services, and health-care policy. Wider implementation of alternative models requires appropriate support for non-oncologist care providers and endorsement of these models by cancer teams with their patients. The COVID-19 pandemic has driven some changes in practice that are more patient-centred and should continue. Improved models should shift from a predominant focus on detection of cancer recurrence and seek to improve the quality of life, functional outcomes, experience, and survival of survivors of cancer, reduce the risk of recurrence and new cancers, improve the management of comorbidities, and reduce costs to patients and payers. This Series paper focuses primarily on high-income countries, where most data have been derived. However, future research should consider the applicability of these models in a wider range of health-care settings and for a wider range of cancers.

Assessing Fatigue in Patients Receiving Kidney Replacement Therapy Using PROMIS Computer Adaptive Testing.

RATIONALE & OBJECTIVE: Fatigue is a debilitating symptom for many patients receiving kidney replacement therapy (KRT). Patient-reported outcome measures can help clinicians identify and manage fatigue efficiently. We assessed the measurement characteristics of the Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue Computer Adaptive Test (PROMIS-F CAT) in patients receiving KRT using the previously validated Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 198 adults treated with dialysis or recipients of a kidney transplant in Toronto, Canada. PREDICTORS: Demographic data, FACIT-F scores, KRT type. OUTCOME: Measurement properties of PROMIS-F CAT T scores. ANALYTICAL APPROACH: Reliability and test-retest reliability were assessed using standard errors of measurement and intraclass correlation coefficient (ICC), respectively. Construct validity was assessed using correlation and comparisons across predefined groups expected to have different levels of fatigue. Receiver operating characteristic (ROC) curves were used to assess the discrimination of PROMIS-F CAT, with clinically relevant fatigue defined by a FACIT-F score of≤30. RESULTS: Of the 198 participants, 57% were male, the mean±SD age was 57±14 years; 65% had received a kidney transplant. Based on the FACIT-F score, 47 patients (24%) had clinically relevant fatigue. PROMIS-F CAT and FACIT-F were strongly correlated (ρ =-0.80, P<0.001). PROMIS-F CAT had excellent reliability (>0.90 for 98% of sample), and good test-retest reliability (ICC=0.85). The ROC analysis demonstrated outstanding discrimination (area under ROC=0.93 [95%, CI 0.89-0.97]). A PROMIS-F CAT cutoff score of≥59 accurately identified most patients with clinically relevant fatigue (sensitivity=0.83; specificity=0.91). LIMITATIONS: A convenience sample of clinically stable patients. FACIT-F items are a part of the PROMIS-F item bank, although there was minimal overlap with only 4 FACIT-F items completed in PROMIS-F CAT. CONCLUSIONS: PROMIS-F CAT has robust measurement properties with low question burden to assess fatigue among patients with KRT.

Associations between Human Papillomavirus Status, Weight Change, and Survival of Oropharyngeal Cancer Patients.

This study examined associations between HPV status and weight change in oropharyngeal cancer (OPC). OPC patients receiving concurrent chemoradiotherapy in Toronto, Canada were included. Relationships were assessed between HPV status and weight loss grade (WLG, combining weight loss and current body mass index); weight change during treatment; and HPV status and WLG/weight change on overall (OS) and cancer-specific (CSS) survival. Of 717 patients, WLG pre-radiation was less severe among HPV-positive compared to HPV-negative, though weight loss during treatment was greater. The adjusted odds ratio for greater WLG among HPV-positive versus HPV-negative was 0.47 (95%CI 0.28-0.78). Grade-4 WLG (worst category) experienced poorer OS and CSS (OS adjusted hazard ratio (aHR) 4.08; 95%CI 1.48-11.2, compared to Grade-0); and was non-significant for HPV-negative (aHR 2.34; 95%CI 0.69-7.95). Relationships between weight change before/during treatment and survival had similar direction between HPV-positive and HPV-negative, but of greater magnitude in HPV-positive patients.

Two-step screening for depressive symptoms in patients treated with kidney replacement therapies: a cross-sectional analysis.

BACKGROUND: Systematic screening for depressive symptoms may identify patients who may benefit from clinical assessment and psychosocial support. Here we assess a two-step screening using ultrabrief pre-screeners [Edmonton Symptom Assessment Survey-revised Depression item (ESASr-D) or Patient Health Questionnaire-2 (PHQ-2)] followed by the Patient-Reported Outcomes Measurement Information System Depression questionnaire (PROMIS-D) to identify depressive symptoms in patients on kidney replacement therapies. METHODS: We conducted a cross-sectional study of adults (kidney transplant recipients or treated with dialysis) in Toronto, ON, Canada. We simulated various two-step screening scenarios where only patients above a pre-screening cut-off score on the ESASr-D or PHQ-2 would move to step 2 (PROMIS-D). Screening performance was evaluated by sensitivity, specificity and positive and negative predictive values using the Patient Health Questionnaire-9 (PHQ-9) as the referent. The average number of items completed by patients in different scenarios was reported. RESULTS: Of 480 participants, 60% were male with a mean age of 55 years. Based on PHQ-9, 19% of patients had moderate or severe depressive symptoms. Pre-screening with a PHQ-2 score ≥1 combined with a PROMIS-D score of ≥53 provided the best two-step results (sensitivity 0.81, specificity 0.84, NPV 0.95). Two-step screening also reduces question burden. CONCLUSIONS: A two-step screening using a PHQ-2 score ≥1 followed by a PROMIS-D score ≥53 has good sensitivity and specificity for identifying potentially significant depressive symptoms among patients on kidney replacement therapies. This approach has lower question burden. Screened-in patients will need further clinical assessment to establish a diagnosis.

Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities.

BACKGROUND: Poorly managed cancer treatment toxicities negatively impact quality of life, but little research has examined patient activation in self-management (SM) early in cancer treatment. METHODS: We undertook a pilot randomized trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the SMARTCare (Self-Management and Activation to Reduce Treatment Toxicities) intervention. This intervention included an online SM education program (I-Can Manage) plus 5 sessions of telephone cancer coaching in patients initiating systemic therapy for lymphoma or colorectal or lung cancer at 3 centers in Ontario, Canada, relative to a usual care control group. Patient-reported outcomes included patient activation (Patient Activation Measure [PAM]), symptom or emotional distress, self-efficacy, and quality of life. Descriptive statistics and Wilcoxon rank-sum tests were used to examine changes over time (baseline and at 2, 4, and 6 months) within and between groups. We used general estimating equations to compare outcomes between groups over time. The intervention group completed an acceptability survey and qualitative interviews. RESULTS: Of 90 patients approached, 62 (68.9%) were enrolled. Mean age of the sample was 60.5 years. Most patients were married (77.1%), were university educated (71%), had colorectal cancer (41.9%) or lymphoma (42.0%), and had stage III or IV disease (75.8%). Attrition was higher in the intervention group than among control subjects (36.7% vs 25%, respectively). Adherence to I-Can Manage was low; 30% of intervention patients completed all 5 coaching calls, but 87% completed ≥1. Both the continuous PAM total score (P<.001) and categorical PAM levels (3/4 vs 1/2) (P=.002) were significantly improved in the intervention group. CONCLUSIONS: SM education and coaching early during cancer treatment may improve patient activation, but a larger trial is needed. CLINICALTRIALS: gov Identifier: NCT03849950.

Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: a mixed methods study.

PURPOSE: Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews. METHODS: Adults with advanced solid tumors and an oncologist-estimated prognosis of 6-36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7; primary outcome), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants. RESULTS: From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n = 33) or usual care (n = 36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p = 0.009). Nonsignificant differences for all outcomes favored STEP: difference in change scores for FACT-G7 = 1.67 (95% CI: -1.43, 4.77); ESAS-r-CS = -5.51 (-14.29, 3.27); FAMCARE P-16 = 4.10 (-0.31, 8.51); PHQ-9 = -2.41 (-5.02, 0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately beneficial; and referral to palliative care as timely. CONCLUSION: Despite lack of power for this halted trial, preliminary results favored STEP and qualitative results demonstrated acceptability. Findings will inform an RCT of combined in-person and virtual STEP.

The Acceptability of Behavioural Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study Exploring Experiences of Clinical Trial Speech-Language Pathologists.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy (RT) namely: reactive, proactive low- ("EAT-RT" only) and high-intensity ("EAT-RT + exercises"). Understanding the experiences of the trial Speech-Language Pathologists (SLPs) will be useful to inform clinical implementation. This study assessed SLP opinions of acceptability and clinical feasibility of the 3 trial therapies. 8 SLPs from 3 Canadian PRO-ACTIVE trial sites participated in individual interviews. Using a qualitative approach, data collection and thematic analysis were guided by the Theoretical Framework of Acceptability. Member checking was conducted through a follow-up focus group with willing participants. Seven themes were derived: intervention coherence, burden, barriers/facilitators, self-efficacy, attitude, ethicality, and perceived effectiveness. SLPs felt all 3 therapies had potential benefit yet perceived more advantages of proactive therapies compared to reactive. Compared to exercises, SLPs particularly endorsed the EAT-RT component. A major barrier was keeping patients motivated, which was impacted by acute toxicity and sometimes conflicting instructions from the healthcare team. Strategies utilized by to overcome barriers included: scaling exercises and/or diet up/down according to the changing patient needs and communicating therapy goals with healthcare team. A model was derived describing the perceived acceptability of the swallowing therapies according to SLPs, based on the interconnection of main themes. Proactive therapies were perceived as more acceptable to trial SLPs, for facilitating patient engagement. The perceived acceptability of the swallowing therapies was related to seven interconnected aspects of providers' experience. These findings will inform the implementation and potential uptake of the PRO-ACTIVE swallowing therapies in clinical practice.

Exploring the Acceptability of Behavioral Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study of Patients' Experience.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy namely: reactive, proactive low- ("EAT-RT" only), and high-intensity ("EAT-RT + exercises"). Understanding the perceived acceptability of these interventions is important to inform eventual implementation into clinical practice. This study explored patients' perspectives using qualitative methodology. At 2 Canadian PRO-ACTIVE trial sites, 24 trial participants were recruited for individual semi-structured interviews, representing each of the 3 trial arms. Data collection and thematic analysis were guided by the Theoretical Framework of Acceptability (TFA). Member checking was conducted through follow-up focus groups. Seven themes were derived reflecting the TFA constructs. Overall, regardless of trial arm, patients reported a positive experience with therapy. Patients identified benefits of EAT-RT therapy, reporting that it provided meaningful feedback on diet progress and supported goal setting for oral intake. Patients who received proactive therapies valued the opportunity to set expectations early, build mealtime routine iteratively over time, and have an extended engagement with the SLP. Regardless of trial arm, patients agreed proactive therapy aligned with what they think is best and that therapy intensity should accommodate individual needs. This study identified the value to HNC patients of receiving swallowing interventions during RT and setting realistic expectations around swallowing. Compared to reactive care, proactive therapies were perceived helpful in consolidating habits early, establishing realistic expectations around swallowing and building an extended rapport with the SLP. These findings will inform the implementation of proactive versus reactive swallowing therapies in clinical practice.

Empowering Cancer Survivors in Managing Their Own Health: A Paradoxical Dynamic Process of Taking and Letting Go of Control.

In cancer care, gaps in support to help patients manage and live with the side-effects from cancer treatments have increased the emphasis on empowering patients to be more active and involved in managing their own health. However, empowerment in relation to promoting self-management behaviors is not well understood. Using the social constructivist grounded theory approach, our goal was to develop a theoretical understanding of this phenomenon in relation to the self-management behaviors of post-treatment cancer patients. Twenty-two post-treatment cancer patients participated in a semi-structured focused interview to co-construct with us how empowerment is defined, described, and experienced in relation to their capacity to self-manage. Through this co-construction, we defined empowerment as a process of personal growth, a display of fortitude and strength when participants confronted the impact of their illness that emerged in two dynamic and paradoxical ways: 1) establishing control over the impact of the illness as a means to maintain normalcy and to circumvent change over an eroding and changing sense of self and 2) relinquishing control over aspects of the illness deemed irrepressible and acknowledging and accepting change. When successful at establishing and/or relinquishing control, participants no longer viewed cancer as a threat, but re-interpreted their illness as also having a beneficial "empowering" experience and more capable of managing. Findings will guide the development of self-management interventions that use empowerment as a core construct.

Psychosocial and supportive care needs of individuals with advanced myeloma.

Purpose: The purpose of this qualitative study is to understand, from the patient's perspective, their experience of living with advanced multiple myeloma, the psychosocial impact, and needs for support in managing and adapting to this illness. Methods: An interpretive descriptive approach was used. Individual semi-structured telephone interviews were conducted with each participant, which focused on eliciting their descriptions of psychosocial issues and concerns, as well as the supports they use for coping with cancer. Transcripts were analyzed using interpretive description, resulting in the generation of common themes that represented the data. Results: The sample comprised twelve adults with a diagnosis of advanced multiple myeloma who had undergone at least three lines of treatment or were transfusion dependent. All participants were receiving ambulatory care for their myeloma in Toronto, Ontario, Canada. Four themes were generated: (1) confusion about the diagnosis and treatment options; (2) challenges in finding relevant information; (3) dealing with the chronicity of treatment side effects; (4) social support as critical for coping with the life-threat of multiple myeloma. Conclusion: Findings suggest that the psychosocial impact of living with advanced multiple myeloma is greatly impacted by one's ability to understand the complexities of the diagnosis and access supports to cope with its physical and emotional consequences. Clinical interventions specifically tailored to meeting the information and support needs of this population are needed.

A proof-of-concept study of iCope: A nurse-led psychoeducational telephone intervention for women attending a rapid diagnostic centre for breast abnormality.

The period between the initial discovery of a suspicious breast lesion and a confirmed diagnosis is a time of significant psychological distress, heightened anxiety, and uncertainty for many women. This proof of concept (PoC) study explored the clinical outcomes and acceptability of iCope, a nurse-led psycho-educational telephone intervention aimed to assist with uncertainty, anxiety and coping in women going through a Rapid Diagnostic Centre (RDC) offering quick diagnosis of breast cancer (same day to three-day post-investigation). Guided by the Uncertainty Theory, and using a one-arm pretest-posttest design, two brief 15-minute telephone sessions were delivered by a nurse prior to the women's day of testing at the RDC and three days after the receipt of their results. Six women completed measures of anxiety, uncertainty, and coping before the clinic visit, three days and three weeks after receiving their test results. Results show that the implementation of the telephone intervention was challenging, yet may offer potential for positive impact. That is, trends of decreased uncertainty and anxiety in participants over time were noted. Considering the difficulty observed in the recruitment and delivering the two interventions in the timeline planned, feasibility testing is recommended before the conduct of a large-scale study.

Risk factors for psychological morbidity and the protective role of coping self-efficacy in young women with breast cancer early in diagnosis: a national multicentre cohort study.

PURPOSE: Young women with breast cancer (YWBC) are an understudied population and there are limited data on risk factors for psychological morbidity early in diagnosis. We examined psychological morbidity (anxiety, depression, stress symptoms), well-being and associated risk factors. METHODS: A total of 845 women from a pan-Canadian, multicentre inception cohort study of YWBC (age ≤ 40) who completed Patient Reported Outcome Measures (PROMs) after their initial surgical consultation and prior to surgical or other treatments were included. Multivariate regression analyses identified risk factors (i.e. parenting young children) associated with psychological morbidity and whether coping self-efficacy was protective. RESULTS: Rates of clinically significant anxiety (n = 683, 69.1%) and depression (n = 422, 42.7%) were high but lower for stress symptoms (n = 67, 6.8%). Probability of anxiety was high for women with a previous history of depression (OR 2.02, P = 0.03, CI 1.09-3.74) and working full-time (OR 1.76, P = 0.05 CI 1.02-2.77). Whereas, pre-existing depression (OR 2.91, P = 0.01, CI 1.36-6.01), younger children (age ≤ 10) (OR 1.69, P = 0.05, CI 1.01-2.93), and income > $100,000 (OR 2.06, P = 0.02, CI 1.18-3.64) were risk factors for depression. Coping self-efficacy was protective with a decreased risk of anxiety (OR 0.11, P ≤ 0.01 CI 0.04-0.28), depression (OR 0.03, P ≤ .01, CI 0.01-0.16), stress symptoms (OR 0.17, P ≤ .01, CI 0.04-0.65) and higher psychosocial well-being with a gain of 19.68 points (P < 0.01) for high levels of CSE (> mean plus 1 SD). Those with lower levels of neurosis had less negative outcomes. CONCLUSION: Young women with breast cancer are vulnerable to psychological morbidity early in diagnosis, particularly those with low coping self-efficacy and may benefit from earlier supportive care.

The association of self-efficacy and health literacy to chemotherapy self-management behaviors and health service utilization.

BACKGROUND: Increasing demands on Canada's healthcare system require patients to take on more active roles in their health. Effective self-management has been linked to improved health outcomes; and there is evidence that effective behaviors, and subsequent healthcare utilization, are linked to self-efficacy and health literacy; however, this link has had minimal testing in the cancer context. Our aim is to examine the association between self-efficacy, health literacy, chemotherapy self-management behaviors, and health service utilization. DESIGN AND METHODS: A cross-sectional survey that included validated measures of self-efficacy, health literacy, chemotherapy self-management, and health service utilization was completed by participants (N = 213). Multivariable modeling using hierarchical linear regression was used to examine the association between variables. RESULTS: Self-efficacy contributed significantly to explaining variation in chemotherapy self-management score. Health literacy was not significantly associated with any of the dependent variables. CONCLUSION: Participants with higher self-efficacy had higher chemotherapy self-management scores compared to participants with low self-efficacy. Contrary to evidence in the chronic disease self-management literature, this study demonstrated that health literacy was not associated with chemotherapy self-management behavior nor was it associated with self-efficacy. Building patient self-efficacy in the context of chemotherapy self-management could be particularly helpful both in the cancer center and in the domain of oral chemotherapy management at home where patients are required to take on significant responsibility for self-management.

Screening for symptoms of anxiety and depression in patients treated with renal replacement therapy: utility of the Edmonton Symptom Assessment System-Revised.

PURPOSE: The Edmonton Symptom Assessment System-revised (ESASr) is widely used in clinical oncology to screen for physical and emotional symptoms. The performance of the anxiety and depression items (ESASr-A and ESASr-D, respectively) as screening tools have not been evaluated in patients treated with renal replacement therapy. METHODS: Kidney transplant recipients and patients on dialysis were recruited in Toronto. Patients were classified as having moderate/severe depression and anxiety symptoms using the established cut-off score of ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9) and the General Anxiety Disorder-7 (GAD-7) questionnaires. RESULTS: This study included 931 participants; 62% male, mean age (SD) 55(16), and 52% White. All participants completed ESASr, however only 748 participants completed PHQ-9 and 769 participants completed GAD-7. Correlation between ESASr item scores and legacy scores were moderately strong (ESASr-D/PHQ-9: 0.61; ESASr-A/GAD-7: 0.64). We found good discrimination for moderate/severe depression and anxiety [area under the receiver operating characteristics curve (95% CI) ESASr-D 0.82(0.78-0.86); ESASr-A 0.87 (0.82, 0.92)]. The cut-off ≥ 2 for ESASr-D [Sensitivity = 0.76; Specificity = 0.77; Likelihood Ratio (LR) + = 3.29; LR - = 0.31] and ≥ 4 for ESASr-A (Sensitivity = 0.75; Specificity = 0.87; LR + = 5.76; LR - = 0.29) had the best combination of measurement characteristics. CONCLUSION: The identified ESASr-D and ESASr-A cut-off scores may be used to rule out patients without emotional distress with few false negatives. However, the low sensitivity identified in our analysis suggests that neither ESASr-D or ESASr-A are acceptable as standalone screening tools.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer.

BACKGROUND: Routine early palliative care (EPC) improves quality of life (QoL) for patients with advanced cancer, but it may not be necessary for all patients. We assessed the feasibility of Symptom screening with Targeted Early Palliative care (STEP) in a phase II trial. METHODS: Patients with advanced cancer were recruited from medical oncology clinics. Symptoms were screened at each visit using the Edmonton Symptom Assessment System-revised (ESAS-r); moderate to severe scores (screen-positive) triggered an email to a palliative care nurse, who called the patient and offered EPC. Patient-reported outcomes of QoL, depression, symptom control, and satisfaction with care were measured at baseline and at 2, 4, and 6 months. The primary aim was to determine feasibility, according to predefined criteria. Secondary aims were to assess whether STEP identified patients with worse patient-reported outcomes and whether screen-positive patients who accepted and received EPC had better outcomes over time than those who did not receive EPC. RESULTS: In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 (56%) received EPC during the 6-month study and 4 (6%) received EPC after the study end. Measure completion was 76% at 2 months, 68% at 4 months, and 63% at 6 months. Among screen-negative patients, QoL, depression, and symptom control were substantially better than for screen-positive patients at baseline (all P<.0001) and remained stable over time. Among screen-positive patients, mood and symptom control improved over time for those who accepted and received EPC and worsened for those who did not receive EPC (P<.01 for trend over time), with no difference in QoL or satisfaction with care. CONCLUSIONS: STEP is feasible in ambulatory patients with advanced cancer and distinguishes between patients who remain stable without EPC and those who benefit from targeted EPC. Acceptance of the triggered EPC visit should be encouraged. CLINICALTRIALS: gov identifier: NCT04044040.

Systematic review of self-management interventions for older adults with cancer.

AIM: The purpose of this systematic review was to determine the effectiveness of self-management interventions for older adults with cancer and to determine the effective components of said interventions. METHODS: We conducted a systematic review of self-management interventions for older adults (65+) with cancer guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. We conducted an exhaustive search of the following databases: Ageline, AMED, ASSIA, CINAHL, Cochrane, Embase, Medline, PsychINFO, and Sociological Abstracts. We assessed for quality using the Cochrane Risk of Bias tool and Down & Black for quasi-experimental studies, with data synthesized in a narrative and tabular format. RESULTS: Sixteen thousand nine hundred and eight-five titles and abstracts were screened, subsequently 452 full-text papers were reviewed by two independent reviewers, of which 13 full-text papers were included in the final review. All self-management interventions included in this review measured Quality of Life; other outcomes included mood, self-care activity, supportive care needs, self-advocacy, pain intensity, and analgesic intake; only one intervention measured frailty. Effective interventions were delivered by a multidisciplinary teams (n = 4), nurses (n = 3), and mental health professionals (n = 1). Self-management core skills most commonly targeted included: problem solving; behavioural self-monitoring and tailoring; and settings goals and action planning. CONCLUSIONS: Global calls to action argue for increased emphasize on self-management but presently, few interventions exist that explicitly target the self-management needs of older adults with cancer. Future work should focus on explicit pathways to support older adults and their caregivers to prepare for and engage in cancer self-management processes and behaviours.

Feasibility of implementing a cervix cancer-specific patient-reported outcome measure in routine ambulatory clinics.

OBJECTIVE: To evaluate the implementation of a cervix cancer-specific patient-reported outcome measure, the European Organization for Research and Treatment of Cancer Quality of Life Cervical Cancer module (EORTC QLQ-CX24), into gynecologic oncology clinics. METHODS: This was a prospective, multi-institutional, cross-sectional study involving cervix cancer patients previously treated with curative intent radiotherapy who were attending routine follow-up appointments. Between January 2017 and August 2018, eligible patients were approached to complete the EORTC QLQ-CX24 prior to their clinical encounter and then review it with their oncologist. Patient and oncologist experience was evaluated using Feedback Questionnaires following the encounter. Descriptive statistics were used to summarize the results of the EORTC QLQ-CX24 and Feedback Questionnaires. Open-ended questions within the Feedback Questionnaires were analyzed to identify themes. RESULTS: Eighty-four patients consented to participate in the study. Of these, 80 (95.2%) completed the EORTC QLQ-CX24 and 76 (90.4%) completed both the EORTC QLQ-CX24 and the Feedback Questionnaires. There were high rates of completion for most items within the EORTC QLQ-CX24 (93-98%), except for items pertaining to vaginal symptoms and sexual health (34-35%). All eligible oncologists participated (n = 9). Overall, patients and oncologists positively endorsed use of the questionnaire during clinical encounters. The majority of patients (80%) and oncologists (89%) reported use of the questionnaire improved communication, including discussion of sensitive topics. Interestingly, only a minority of patients and oncologists stated a perceived preference for electronic completion (18% and 44%, respectively). CONCLUSION: Implementation of the EORTC QLQ-CX24 in gynecologic oncology clinics was feasible and acceptable according to patients and oncologists.