Evaluation of centers for information and support combining formal and informal care for patients with cancer: a systematic review of the literature.

PURPOSE: Clear information and supportive care are necessary for patients with cancer to effectively manage their condition. Traditionally, healthcare professionals offer information and support via the so-called formal care route. In addition, research has found favorable effects of informal care provided by volunteer programs and informal "walk-in support centers." Less research has been done on initiatives that combine formal and complementary informal supportive care for patients with cancer. This systematic literature study aimed to discover (1) which types of initiatives are described in the literature, (2) what type of care they offer, and (3). how they are evaluated in terms of outcome measures. METHODS: We performed a systematic literature search of MEDLINE, Embase, PsycINFO, and CINAHL. Studies were included if the collaboration between one type of formal care together with one type of informal care was explicitly mentioned in the article. The search was not restricted to a specific cancer type. RESULTS: A total of 4869 records were retrieved and 18 studies were included. In most studies, the care provided consisted of emotional support for, and/or providing information to, patients and their families. Initiatives were evaluated with interviews and questionnaires. Patients with cancer reported that they were satisfied with the care offered, including information, social and emotional support, help with activities of daily living, and family-related issues. Volunteers reported that visits they made were experienced positive and rewarding and the volunteers were confident about their contribution to general healthcare. Some negative experiences were reported by volunteers, e.g., interference of their own cancer diagnosis with volunteer work. The importance of proper training was stressed. CONCLUSIONS: Initiatives combining formal and informal supportive care hold the potential of added value in terms of providing emotional support for, and providing information to, patients with cancer. Support and specific training for volunteers can be viewed as success factors in the involvement of volunteers in formal care practices.

Untangling the relationship between negative illness perceptions and worse quality of life in patients with advanced cancer-a study from the population-based PROFILES registry.

PURPOSE: Quality of life (QoL) is an important yet complex outcome of care in patients with advanced cancer. QoL is associated with physical and psychosocial symptoms and with patients' illness perceptions (IPs). IPs are modifiable cognitive constructs developed to make sense of one's illness. It is unclear how IPs influence patients' QoL. A better understanding of this relationship can inform and direct high quality care aimed at improving patients' QoL. We therefore investigated the mediating role of anxiety and depression in the association of IPs with QoL. METHODS: Data from 377 patients with advanced cancer were used from the PROFILES registry. Patients completed measures on IPs (BIPQ), QoL (EORTC QLQ-C30), and symptoms of anxiety and depression (HADS). Mediation analyses were conducted to decompose the total effect of IPs on QoL into a direct effect and indirect effect. RESULTS: All IPs but one ("Comprehensibility") were negatively associated with QoL (p<0.001); patients with more negative IPs tended to have worse QoL. The effect was strongest for patients who felt that their illness affected their life more severely ("Consequences"), patients who were more concerned about their illness ("Concern"), and patients who thought that their illness strongly affected them emotionally ("Emotions"). Anxiety mediated 41-87% and depression mediated 39-69% of the total effect of patients' IPs on QoL. CONCLUSION: Negative IPs are associated with worse QoL. Anxiety and depression mediate this association. Targeting symptoms of anxiety and depression, through the modification of IPs, has the potential to improve QoL of patients with advanced cancer.

Functional impairment, symptom severity, and overall quality of life in patients with advanced lung or colorectal cancer in six European countries: baseline findings from the ACTION study.

BACKGROUND: People with advanced cancer often suffer from various symptoms, which can arise from the cancer itself and its treatment, the illness experience, and/or co-morbid conditions. Important patient-reported outcomes such as functional status, symptom severity, and quality of life (QoL) might differ between countries, as countries vary with regard to contextual factors such as their healthcare system. PURPOSE: To assess self-reported emotional functioning, physical functioning, symptoms, and overall QoL in patients with advanced lung or colorectal cancer from six European countries, particularly in relation to their country of residence. METHODS: We used baseline patient data from the ACTION trial, including socio-demographic and clinical data as well as patient-reported data regarding functioning, symptoms, and overall QoL (EORTC QLQ-C15-PAL). RESULTS: Data from 1117 patients (55% lung cancer stage III/IV, 45% colorectal cancer stage IV) were used. The highest (worst) average symptom score was found for fatigue. We found similarities but also important differences in the outcomes across countries. The best scores (the highest for emotional functioning and QoL, the lowest for symptoms) were reported by Dutch and Danish patients. Belgian patients reported relatively low emotional functioning. CONCLUSION: The optimization of functioning, symptom relief, and overall QoL should be important objectives of healthcare professionals who take care of patients with advanced cancer. There are similarities, but also substantial differences across countries in functional status, symptoms, and overall QoL. Policymakers should take these differences into account and invest in offering health care catered to the needs of their population.

Advance care planning in patients with advanced cancer: A 6-country, cluster-randomised clinical trial.

BACKGROUND: Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce. METHODS AND FINDINGS: To test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised advance directives. Control patients received care as usual. Main outcome measures were quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms. Secondary outcomes were coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care. In all, 1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire. Patients' age ranged from 18 to 91 years, with a mean of 66; 39% were female. The mean number of ACP conversations per patient was 1.3. Fidelity was 86%. Sixteen percent of patients found ACP conversations distressing. Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making. Specialist palliative care (37% versus 27%, p = 0.002) and AD inclusion in hospital files (10% versus 3%, p < 0.001) were more likely in the intervention group. A key limitation of the study is that recruitment rates were lower in intervention than in control hospitals. CONCLUSIONS: Our results show that quality of life effects were not different between patients who had ACP conversations and those who received usual care. The increased use of specialist palliative care and AD inclusion in hospital files of intervention patients is meaningful and requires further study. Our findings suggest that alternative approaches to support patient-centred end-of-life care in this population are needed. TRIAL REGISTRATION: ISRCTN registry ISRCTN63110516.

Coping strategies of patients with advanced lung or colorectal cancer in six European countries: Insights from the ACTION Study.

OBJECTIVE: Even when medical treatments are limited, supporting patients' coping strategies could improve their quality of life. Greater understanding of patients' coping strategies, and influencing factors, can aid developing such support. We examined the prevalence of coping strategies and associated variables. METHODS: We used sociodemographic and baseline data from the ACTION trial, including measures of Denial, Acceptance, and Problem-focused coping (COPE; Brief COPE inventory), of patients with advanced cancer from six European countries. Clinicians provided clinical information. Linear mixed models with clustering at hospital level were used. RESULTS: Data from 675 patients with stage III/IV lung (342, 51%) or stage IV colorectal (333, 49%) cancer were used; mean age 66 (10 SD) years. Overall, patients scored low on Denial and high on Acceptance and Problem-focused coping. Older age was associated with higher scores on Denial than younger age (ß = 0.05; CI[0.023; 0.074]), and patients from Italy (ß = 1.57 CI[0.760; 2.388]) and Denmark (ß = 1.82 CI[0.881; 2.750]) scored higher on Denial than patients in other countries. CONCLUSIONS: Patients with advanced cancer predominantly used Acceptance and Problem-focused coping, and Denial to a lesser extent. Since the studied coping strategies of patients with advanced cancer vary between subpopulations, we recommend taking these factors into account when developing tailored interventions to support patients' coping strategies.

Assessing Emotional Functioning with Increased Power: Relative Validity of a Customized EORTC Short Form in the International ACTION Trial.

OBJECTIVES: There is a need to improve the assessment of emotional functioning (EF). In the international Advance Care Planning: an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients - a Multi-Centre Cluster Randomized Clinical Trial (ACTION) trial involving patients with advanced cancer, EF was assessed by a customized 10-item short form (EF10). The EF10 is based on the European Organisation for Research and Treatment of Cancer (EORTC) EF item bank and has the potential for greater precision than the common EORTC Quality of Life Questionnaire Core 30 four-item scale (EF4). We assessed the relative validity (RV) of EF10 compared with EF4. METHODS: Patients from Belgium, Denmark, Italy, the Netherlands, Slovenia, and the United Kingdom completed EF10 and EF4, and provided data on generic quality of life, coping, self-efficacy, and personal characteristics. Based on clinical and sociodemographic variables and questionnaire responses, 53 "known groups" that were expected to differ were formed, for example, females versus males. The EF10 and EF4 were first independently compared within this known group, for example, the EF10 score of females vs the EF10 score of males. When these differences were significant, the RV was calculated for the comparison of the EF10 with the EF4. RESULTS: A total of 1028 patients (57% lung, 43% colorectal cancer) participated. Forty-five of the 53 known-groups comparisons were significantly different and were used for calculating the RV. In 41 of 45 (91%) comparisons, the RV was more than 1, meaning that EF10 had a higher RV than EF4. The mean RV of EF10 compared with that of EF4 was 1.41, indicating superior statistical power of EF10 to detect differences in EF. CONCLUSIONS: Compared with EF4, EF10 shows superior power, allowing a 20% to 34% smaller sample size without reducing power, when used as a primary outcome measure.

Advance care planning for patients with chronic respiratory diseases: a systematic review of preferences and practices.

BACKGROUND: Advance care planning (ACP) supports patients in identifying and documenting their preferences and timely discussing them with their relatives and healthcare professionals (HCPs). Since the British Thoracic Society encourages ACP in chronic respiratory disease, the objective was to systematically review ACP practice in chronic respiratory disease, attitudes of patients and HCPs and barriers and facilitators related to engagement in ACP. METHODS: We systematically searched 12 electronic databases for empirical studies on ACP in adults with chronic respiratory diseases. Identified studies underwent full review and data extraction. RESULTS: Of 2509 studies, 21 were eligible: 10 were quantitative studies. Although a majority of patients was interested in engaging in ACP, ACP was rarely carried out. Many HCPs acknowledged the importance of ACP but were hesitant to initiate it. Barriers to engagement in ACP were the complex disease course of patients with chronic respiratory diseases, HCPs' concern of taking away patients' hopes and lack of continuity of care. The identification of trigger points and training of HCPs on how to communicate sensitive topics were identified as facilitators to engagement in ACP. CONCLUSIONS: In conclusion, ACP is surprisingly uncommon in chronic respiratory disease, possibly due to the complex disease course of chronic respiratory diseases and ambivalence of both patients and HCPs to engage in ACP. Providing patients with information about their disease can help meeting their needs. Additionally, support of HCPs through identification of trigger points, training and system-related changes can facilitate engagement in ACP. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42016039787.

Low patient activation levels in frail older adults: a cross-sectional study.

BACKGROUND: Frail older adults are increasingly expected to self-manage their health and healthcare. We assessed the extent to which this group is able to take up this responsibility by measuring their level of activation as patients (i.e. their knowledge, skills and confidence to self-manage their health and healthcare). Further, we studied which characteristics of older adults were associated with patient activation. METHODS: In this cross-sectional study 200 frail, competent adults (median age 87 years) participated. Participants were community-dwelling adults who received home care and residents of care homes. Data were collected via personal interviews in participants' homes. The main outcome measure was patient activation assessed by the short version of the Patient Activation Measure (PAM-13; range: 0-100). The PAM distinguishes four levels of increasing activation with level 1 indicating poor patient activation and level 4 adequate patient activation. Other studied variables were: multimorbidity, type of residency, frailty (Tilburg Frailty Index), mental competence (Mini Mental State Examination), health-related quality of life (SF-12), satisfaction with healthcare (subscale Patient Satisfaction Questionnaire) and personal characteristics (age, gender, marital status, educational level). Regression analyses were performed to investigate which variables were associated with patient activation. RESULTS: Participants had a median PAM score of 51. Thirty-nine percent had level 1 activation, 31% level 2, 26% level 3 and 5% level 4. Fifty-nine percent of community dwelling adults had level 1 or 2 activation versus 81% of care home residents (p = 0.007). Mental competence (Effect: 0.52, CI: 0.03-1.01, p = 0.04) and health-related quality of life (Effect: 0.15, CI: 0.01-0.30, p = 0.04 for physical health; Effect: 0.20, CI: 0.07-0.34, p = 0.003 for mental health) were positively associated with patient activation. Frailty (Effect: -1.06, CI: -1.75 - -0.36, p = 0.003) was negatively associated with patient activation. CONCLUSIONS: The majority of this frail and very old study population, especially those with a lower health-related quality of life, may be unable to self-manage their health and healthcare to the level expected from them. The increasing population of frail older adults may need help in managing their health and healthcare.

Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.

BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients' quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.

A cluster randomized controlled trial on the effects and costs of advance care planning in elderly care: study protocol.

BACKGROUND: Currently, health care and medical decision-making at the end of life for older people are often insufficiently patient-centred. In this trial we study the effects of Advance Care Planning (ACP), a formalised process of timely communication about care preferences at the end of life, for frail older people. METHODS/DESIGN: We will conduct a cluster randomised controlled trial among older people residing in care homes or receiving home care in the Netherlands. The intervention group will receive the ACP program Respecting Choices® in addition to usual care. The control group will receive usual care only. Participants in both groups will fill out questionnaires at baseline and after 12 months. We hypothesize that ACP will lead to better patient activation in medical decision making and quality of life, while reducing the number of medical interventions and thus health care costs. Multivariate analysis will be used to compare differences between the intervention group and the control group at baseline and to compare differences in changes after 12 months following the inclusion. DISCUSSION: Our study can contribute to more understanding of the effects of ACP on patient activation and quality of life in frail older people. Further, we will gain insight in the costs and cost-effectiveness of ACP. This study will facilitate ACP policy for older people in the Netherlands. TRIAL REGISTRATION: Nederlands Trial Register: NTR4454.

Impact of the COVID-19 pandemic on working conditions and mental well-being of mental health professionals in the Netherlands: a cross-sectional study.

OBJECTIVES: To examine the extent of the impact of the COVID-19 pandemic on the mental health and well-being of mental health professionals (MHPs) in the Netherlands and understand their needs during the COVID-19 pandemic. DESIGN AND SETTING: A cross-sectional, mixed-methods study was conducted with MHPs from the Netherlands from June 2020 to October 2020, consisting of an online survey and three online focus group discussions. PARTICIPANTS: Participants were MHPs from various occupational groups (psychologists, social workers, mental health nurses, developmental education workers, etc). PRIMARY AND SECONDARY OUTCOME MEASURES: The online survey included questions about work-related changes due to COVID-19 perceived resilience to stress, changes in lifestyle behaviours and mental health symptoms. The focus group discussions focused mostly on work experiences during the first wave of the COVID-19 pandemic. RESULTS: MHP's reported an increase in experience workload during the pandemic (mean score 8.04 based on a scale of 1-10) compared to before the pandemic (mean score of 7). During the first wave of the pandemic, 50% of respondents reported increased stress, 32% increased sleeping problems and 24% increased mental health problems. Adverse occupational (eg, increased workload OR 1.72, 95% CI 1.28-2.32), psychological (eg, life satisfaction OR 0.63, 95% CI 0.52-0.75), lifestyle (eg, increased sleep problems OR 2.80, 95% CI 2.07-3.80) and physical factors (decline in physical health OR 3.56, 95% CI 2.61-4.85) were associated with a decline in mental health. Participants expressed significant concern in the focus group discussions about the duration of the pandemic, the high workload, less work-life balance and lack of contact with colleagues. Suggestions to improve working conditions included ensuring clear communication about guidelines and facilitating worker contact and support via peer-to-peer coaching where experiences can be shared. CONCLUSIONS: The current study indicates that MHP experienced a decline in mental health status during the first wave of the COVID-19 pandemic, which should be taken into consideration by employers, policymakers and researchers.

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review.

BACKGROUND: For many patients with advanced cancer, the decision whether to participate in early phase clinical trials or not is complex. The decision-making process requires an in-depth discussion of patient values. We therefore aimed to synthesize and describe patient values that may affect early phase clinical trial participation. METHODS: We conducted a systematic search in seven electronic databases on patient values in relation to patients' decisions to participate in early phase clinical cancer trials. RESULTS: From 3072 retrieved articles, eleven quantitative and five qualitative studies fulfilled our inclusion criteria. We extracted ten patient values that can contribute to patients' decisions. Overall, patients who seek trial participation usually report hope, trust, quantity of life, altruism, perseverance, faith and/or risk tolerance as important values. Quality of life and humanity are main values of patients who refuse trial participation. Autonomy and social adherence can be reported by both trial seekers or refusers, dependent upon how they are manifested in a patient. CONCLUSIONS: We identified patient values that frequently play a role in the decision-making process. In the setting of discussing early phase clinical trial participation with patients, healthcare professionals need to be aware of these values. This analysis supports the importance of individual exploration of values. Patients that become aware of their values, e.g. by means of interventions focused on clarifying their values, could feel more empowered to choose. Subsequently, healthcare professionals could improve their support in a patients' decision-making process and reduce the chance of decisional conflict.

Summarizing Patient Preferences for the Competitive Landscape of Multiple Sclerosis Treatment Options.

Objective. Quantitatively summarize patient preferences for European licensed relapsing-remitting multiple sclerosis (RRMS) disease-modifying treatment (DMT) options. Methods. To identify and summarize the most important RRMS DMT characteristics, a literature review, exploratory physician interviews, patient focus groups, and confirmatory physician interviews were conducted in Germany, the United Kingdom, and the Netherlands. A discrete choice experiment (DCE) was developed and executed to measure patient preferences for the most important DMT characteristics. The resulting DCE data (n=799 and n=363 respondents in the United Kingdom and Germany, respectively) were analyzed using Bayesian mixed logit models. The estimated individual-level patient preferences were subsequently summarized using 3 additional analyses: the quality of the choice data was assessed using individual-level R2 estimates, individual-level preferences for the available DMTs were aggregated into DMT-specific preference shares, and a principal component analysis was performed to explain the patients' choice process. Results. DMT usage differed between RRMS patients in Germany and the United Kingdom but aggregate patient preferences were similar. Across countries, 42% of all patients preferred oral medications, 38% infusions, 16% injections, and 4% no DMT. The most often preferred DMT was natalizumab (26%) and oral DMT cladribine tablets (22%). The least often preferred were mitoxantrone and the beta-interferon injections (1%-3%). Patient preferences were strongly correlated with patients' MS disease duration and DMT experience, and differences in patient preferences could be summarized using 8 principle components that together explain 99% of the variation in patients' DMT preferences. Conclusion. This study summarizes patient preferences for the included DMTs, facilitates shared decision making along the dimensions that are relevant to RRMS patients, and introduces methods in the medical DCE literature that are ideally suited to summarize the impact of DMT introductions in preexisting treatment landscapes.

The Stability of Treatment Preferences Among Patients With Advanced Cancer.

CONTEXT: Stability of patients' treatment preferences has important implications for decisions about concurrent and future treatment. OBJECTIVES: To examine the stability of treatment preferences and correlates among patients with advanced cancer. METHODS: In this cohort, 104 patients with metastatic cancer, progression after at least one chemotherapy regimen, and an oncologist-estimated life expectancy of six or fewer months participated in structured interviews after clinical visits in which patients' recent scan results were discussed. Interviews were repeated in three monthly follow-ups. At baseline, patients' age, education, sex, race, marital status, insurance status, and type of cancer were documented. At each assessment, patients reported their treatment preferences (i.e., prioritizing life-prolonging vs. comfort), quality of life, and current health status. RESULTS: At baseline (n = 104), 55 (53%) patients preferred life-prolonging care and 49 (47%) preferred comfort care. Patients were followed up for one (n = 104), two (n = 74), or three months (n = 44). Between baseline and Month 1, 84 patients (81%) had stable preferences. During follow-up, preferences of 71 patients (68%) remained stable (equally divided between a consistent preference for life-prolonging and comfort care). Treatment preferences of 33 (32%) patients changed at least once during follow-up. Direction of change was inconsistent. Patients' preferences at baseline strongly predicted preferences at Month 1 (odds ratio = 17.8; confidence interval = 6.7-47.3; P < .001). Description of the current health status at baseline was the only variable significantly associated with stability of preferences at Month 1. CONCLUSION: Two-thirds of patients with advanced cancer had stable preferences. Changes of preferences were often inconsistent and unpredictable. Our findings suggest potential benefits of ongoing communication about preferences.

Advance Care Planning in Frail Older Adults: A Cluster Randomized Controlled Trial.

OBJECTIVES: To determine the effectiveness of advance care planning (ACP) in frail older adults. DESIGN: Cluster randomized controlled trial. SETTING: Residential care homes in the Netherlands (N=16). PARTICIPANTS: Care home residents and community-dwelling adults receiving home care (N=201; n=101 intervention; n=100 control). Participants were 75 years and older, frail, and capable of consenting to participation. INTERVENTION: Adjusted Respecting Choices ACP program. MEASUREMENTS: The primary outcome was change in patient activation (Patient Activation Measure, PAM-13) between baseline and 12-month follow-up. Secondary outcomes included change in quality of life (SF-12), advance directive (AD) completion, and surrogate decision-maker appointment. Use of medical care in the 12 months after inclusion was also assessed. Multilevel analyses were performed, controlling for clustering effects and differences in demographics. RESULTS: Seventy-seven intervention participants and 83 controls completed the follow-up assessment. There were no statistically significant differences between the intervention (-0.26±11.2) and control group (-1.43±10.6) in change scores of the PAM (p=.43) or the SF-12. Of intervention group participants, 93% completed an AD, and 94% appointed a decision-maker. Of control participants, 34% completed an AD, and 67% appointed a decision-maker (p<.001). No differences in the use of medical care were found. CONCLUSIONS: ACP did not increase levels of patient activation or quality of life but did increase completion of ADs and appointment of surrogate decision-makers. It did not affect use of medical care.