Including 'Work as a Treatment Goal' in the Care for Patients with Chronic Diseases : The Development of a Generic Care Model-A Descriptive Study.

BACKGROUND: The Netherlands faces 60% prevalence of chronic conditions by 2040, impacting societal participation and quality of life. Current clinical care inadequately addresses these consequences, and most hospitals do not integrate occupational health in their care. OBJECTIVES: To develop a generic person- and work-oriented medical care model (WMCM) based on real life experiences with work-oriented care and supporting the chronically ill in active societal participation. METHODS: A qualitative research project with a participative approach in one hospital (November 2019 until March 2020). In an expert meeting, a schematic representation of a work-oriented care model was developed. Subsequent discussion rounds, with professionals from different patient groups, iteratively refined the model to a WMCM. RESULTS: Consensus was reached after seven rounds of discussion, defining the model's core elements (1) a combination of biomedical and biopsychosocial approaches, (2) involvement of a clinical occupational physician in the treatment team, (3) a coordinating role for nursing specialists, and (4) incorporation of a work-oriented intervention plan (WoIP) into the treatment plan. Advocating early attention to societal participation, the model emphasises the WoIP and consensus on monitoring indicators. The final goal is a sustainable return to societal participation, considering both quality of life and work. CONCLUSION: It is feasible to develop a generic person- and work-oriented care model for patients with chronic illness within a hospital care setting. Collaboration between healthcare professionals and a specialised occupational physician, with a central role for nurses, is deemed crucial.

Does a regular nurse-led distress screening and discussion improve quality of life of breast cancer patients treated with curative intent? A randomized controlled trial.

OBJECTIVE: We performed a randomized controlled trial (RCT) to investigate whether regular screening with the distress thermometer (DT) by a nurse improved global quality of life (QOL) of patients with breast cancer (BC) treated with curative intent. METHODS: BC patients were randomized between regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC). Both groups filled out questionnaires at baseline, after each received treatment modality and at follow-up visits up to 2 years. At these points, the intervention group received also the NDTI. The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after the end of treatment. Analyses were done on an intention-to-treat basis, using analysis of covariance (ANCOVA), generalized least squares, and interaction analyses. RESULTS: Of 194 randomized patients, 153 filled out the questionnaires up to 2 years after treatment. There was no significant difference between NDTI and UC in global QOL 2 years after the end of treatment (mean diff. = -1∙273, P = .610; 95% CI [-6.195; 3.649]). Subgroup analysis of patients who received multimodality treatment (surgery, radiotherapy, and chemotherapy, n = 66) showed a significant between-group difference in global QOL over time (mean diff. = -10, P < .001; 95% CI [-14.835; -5.167]) together with other secondary outcome measures in favor of the NDTI. CONCLUSION: NDTI did not lead to a significant improvement in global QOL 2 years after the end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment may benefit from NDTI.

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

BACKGROUND: Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. METHODS: The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. DISCUSSION: To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. TRIAL REGISTRATION: NTR3812 ; date of registration: 23/01/2013.

The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial.

BACKGROUND: Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT on the psychosocial wellbeing of the patient are unknown. A study to assess the psychosocial consequences of the systematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer is needed. METHODS/DESIGN: The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded randomized controlled trial. Patients treated with curative intent for breast cancer will be recruited from the Radboud University Medical Center. The intervention consists of the DT together with discussion of the results with the patient by a trained oncology nurse added to the usual care. Patients will be randomly allocated (1:1) to either receive usual care or the usual care plus the intervention. Primary outcome measure is global quality of life measured with the EORTC QLQ-C30. The functional and symptom scales of the EORTC QLQ-C30 and BR23, Hospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline and final measurement only) will be used to measure secondary outcomes. Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three and six months' interval during the first and second year respectively. DISCUSSION: This study will be the first randomized controlled longitudinal study about the effectiveness of the DT as nurse led-intervention. In case of proven effectiveness, future implementation and standardization of use of the DT as part of routine care will be recommended. TRIAL REGISTRATION: This study is registered at clinicaltrial.gov march 17, 2010 ( NCT01091584 ).

Fatigue in Advanced Cancer Patients: Congruence Between Patients and Their Informal Caregivers About Patients' Fatigue Severity During Cancer Treatment With Palliative Intent and Predictors of Agreement.

CONTEXT: Informal caregivers (ICs) are increasingly involved in the monitoring of symptoms during advanced cancer patients' treatment with palliative intent. A common but subjective symptom during this extended treatment phase is fatigue. OBJECTIVES: This exploratory longitudinal study aimed to determine agreement between patients and ICs about patients' fatigue severity. In addition, predictors of agreement over time were studied. METHODS: A sample of 107 patients with advanced cancer (life expectancy ≥ six months) and their ICs completed the subscale fatigue severity of the Checklist Individual Strength based on the patient's status at baseline and six months later. This eight-item subscale has a validated cutoff to determine the presence of clinically relevant levels of fatigue. ICs' own fatigue severity, strain, self-esteem, and relationship satisfaction were examined as predictors of agreement. RESULTS: A total of 107 dyads completed measures at baseline and 69 dyads six months later. At baseline, ICs' significantly overestimated patients' fatigue severity (P < 0.001) with a moderate amount of bias (Cohen's d = 0.48). In 81 of the 107 dyads (76%), there was congruence about the presence or absence of severe fatigue. On a group level, congruence did not significantly change over time. On a dyad level, there was a tendency to either remain congruent or reach congruence. Next to baseline congruence, ICs' fatigue severity and strain predicted ICs' fatigue ratings (R(2) = 0.22). CONCLUSION: Most ICs accurately predict presence or absence of clinically relevant levels of patients' fatigue. ICs' own fatigue severity and strain should be taken into account as they influence agreement.

Fatigue and its associated psychosocial factors in cancer patients on active palliative treatment measured over time.

PURPOSE: Fatigue is a frequently reported symptom by patients with advanced cancer, but hardly any prospective information is available about fatigue while on treatment in the palliative setting. In a previous cross-sectional study, we found several factors contributing to fatigue in these patients. In this study, we investigated the course of fatigue over time and if psychosocial factors were associated with fatigue over time. METHODS: Patients on cancer treatment for incurable solid tumors were observed over 6 months. Patients filled in the Checklist Individual Strength monthly to measure the course of fatigue. Baseline questionnaires were used to measure disease acceptance, anxiety, depressive mood, fatigue catastrophizing, sleeping problems, discrepancies in social support, and self-reported physical activity for their relation with fatigue over time. RESULTS: At baseline 137 patients and after 6 months 89 patients participated. The mean duration of participation was 4.9 months. At most time points, fatigue scores were significantly higher in the group dropouts in comparison with the group participating 6 months (completers). Overall fatigue levels remained stable over time for the majority of participants. In the completers, 42% never experienced severe fatigue, 29% persisted being severely fatigued, and others had either an increasing or decreasing level. Of the investigated factors, low reported physical activity and non-acceptance of cancer were associated significantly to fatigue. CONCLUSION: A substantial number of participants never experienced severe fatigue and fatigue levels remained stable over time. For those who do experience severe fatigue, non-acceptance of having incurable cancer and low self-reported physical activity may be fatigue-perpetuating factors.

How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death.

OBJECTIVE: It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death. METHOD: This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey. RESULTS: The median age of the 58 participating partners was 58 years (range: 51-65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators. SIGNIFICANCE OF RESULTS: Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.

Exploring the Routine Administration of Decision Aids for Palliative Chemotherapy to Patients by Nurses: A Qualitative Study Among Nurses and Oncologists.

BACKGROUND: Decision aids (DAs) effectively support patient decision making but are rarely used in daily practice. OBJECTIVE: To explore nurses' and oncologists' views on routinely offering DAs on palliative chemotherapy to patients by nurses. Most interviewees had clinical experience with the DAs, which were booklets administered to patients by nurses. METHODS: The study was guided by 3 theoretical implementation models of innovations in clinical practice, including factors related to the innovation, the professionals (nurses and oncologists), the patient, and the organization. Semistructured interviews were conducted among 12 nurses and 14 oncologists. Interviews were audio taped and fully transcribed. RESULTS: The main barriers to routinely offering DAs to patients were found in nurses' and oncologists' opinions and attitudes (eg, concerns about the impact in this vulnerable population) and in the logistics of organizations (eg, the decision is already made before the nurse sees the patient). Twenty-two of 26 interviewees were open to the future use of the DAs. Disseminating information to professionals (eg, about positive effects of DAs) and embedding DAs in the existing workflow would facilitate implementation. CONCLUSIONS: Most nurses and oncologists were open to the future use of the DAs by nurses, provided that certain barriers, particularly related to professionals' opinions and attitudes and logistical procedures in the organization, could be overcome. IMPLICATIONS FOR PRACTICE: These findings can inform a tailored strategy to implement DAs on palliative chemotherapy. Implementation should start with interventions to motivate professionals, for example, educational meetings.

A prospective analysis on fatigue and experienced burden in informal caregivers of cancer patients during cancer treatment in the palliative phase.

BACKGROUND: Although fatigue is the most frequently occurring symptom in patients with cancer, hardly anything is known about fatigue of their informal caregivers and the impact fatigue might have on perceived burden with providing care. We investigated the presence of fatigue in caregivers, its course and the relation of fatigue severity between caregivers and patients. Furthermore, we explored in caregivers whether fatigue severity was correlated to experienced burden. MATERIAL AND METHODS: Informal caregivers and patients on cancer treatment in the palliative phase completed questionnaires at baseline and follow-up (6 months later). To measure fatigue severity, both groups completed the Checklist Individual Strength. Additionally, caregivers completed the Caregivers Strain Index to assess experienced burden with providing care. Descriptive analyses, paired t-tests, χ(2)-tests, Pearson's correlations and regression analysis were performed. RESULTS: At baseline 111 couples (patients and caregivers) participated, at follow-up 75 couples. At both time points 23% of caregivers were severely fatigued. There was no significant correlation between patients and caregivers on fatigue. Higher fatigue in both patients and caregivers was correlated with higher burden in caregivers and over 30% of burden could be explained by fatigue. CONCLUSION: Almost a quarter of caregivers of patients on active palliative treatment were severely fatigued, which figure remained stable over time. Fatigue in both patients and caregivers was related to caregivers' burden. This observation should be taken into account with the growing demand on caregivers and the increase in cancer treatment options in the palliative setting.

Exploring the contribution of psychosocial factors to fatigue in patients with advanced incurable cancer.

OBJECTIVE: Fatigue is the most frequently occurring and distressing symptom in patients with advanced cancer, caused by multiple factors. Neither a specific histological diagnosis of malignancy nor the type of anticancer treatment seem to be strongly related to fatigue, which support the idea that other factors may play a role. This study investigated to what extent the model of fatigue-perpetuating factors that is known for cancer survivors was applicable for patients with advanced cancer. METHODS: Patients on active treatment for various incurable cancers were asked to complete the Checklist Individual Strength, subscale fatigue severity and physical activity, the Acceptance scale of the Illness Cognition Questionnaire, the Hospital Anxiety and Depression Scale, the Fatigue Catastrophizing Scale, the Symptom Checklist subscale sleep, and the van Sonderen Social Support List-Discrepancies. RESULTS: The questionnaires were filled in by 137 patients. Inappropriate coping, fear of progression, fatigue catastrophizing, discrepancies in social support, depressive mood, self reported physical activity, and sleeping problems were all related to fatigue severity in univariate analyses, of which the latter two were significant in a multivariate linear regression analysis. CONCLUSION: This study tested fatigue-perpetuating factors known to be of relevance in cancer survivors, for their relation with fatigue severity in palliative patients. We demonstrated that these factors were also relevant for patients on palliative treatment. On the basis of our results, we suggest clinicians confronted with palliative patients with serious fatigue to address sleeping problems and promote physical activity. In case of persistent fatigue, personalized cognitive behavioral therapy can be considered.

Severe fatigue during the palliative treatment phase of cancer: an exploratory study.

BACKGROUND: Because of a rise in incidence and more effective treatments, the prevalence of patients with metastatic cancer is increasing fast. When palliative treatment is aimed at maintaining or improving patients' quality of life, knowledge about severe fatigue is clinically relevant because of its debilitating effect, but at present this information is lacking. OBJECTIVE: This study investigated the prevalence of severe fatigue in patients with various incurable cancers and whether severe fatigue increased with further treatment lines and differed between various cancers and treatment modalities. In addition, a relationship between severe fatigue and other symptoms was examined. METHODS: Patients were asked to fill in the Checklist Individual Strength, European Organization of Research and Treatment of Cancer-Quality of Life Questionnaire C30, and the McGill Pain Questionnaire during palliative anticancer treatment, and hemoglobin levels were collected. RESULTS: Of all participating patients (n = 137), 47% were severely fatigued. Patients who received first line of treatment were significantly less often severely fatigued (40%) compared with patients who received further lines (60%). Significantly more severe fatigue was observed when patients had more pain, dyspnea, appetite loss, nausea, vomiting, and constipation. CONCLUSIONS: During the phase of palliative anticancer treatment, fatigue was the most common symptom, nearly half of the patients had severe fatigue increasing with further treatment lines. Various treatment-related symptoms were related to more severe fatigue. IMPLICATIONS FOR PRACTICE: As severe fatigue is significantly related to other symptoms of cancer and its treatment, the screening and treatment of these cancer-related symptoms should be more stringent, as they might negatively influence each other.

Moderators and long-term effectiveness of cognitive behaviour therapy for fatigue during cancer treatment.

OBJECTIVE: A randomised controlled trial (RCT) demonstrated that cognitive behaviour therapy (CBT) for fatigue during curative cancer treatment was effective shortly after cancer treatment. This study aimed to identify which patient characteristics predict fatigue improvement after CBT. In addition, the long-term effectiveness was investigated. METHODS: Patients with various malignancies participated in the RCT (n = 210). Participants were assessed before cancer treatment (T1), postintervention (T2), which was at least 2 months after cancer treatment, and after 1-year follow-up (T3). Monthly fatigue assessments were completed between T2 and T3. A regression analysis with interactions was performed to determine if domains of quality of life (EORTC-QLQ-C30) functioning (Health Survey Short Form-36) or psychological distress (Symptom Checklist-90) moderated the effect of CBT on fatigue. Analyses of covariance were used to study the long-term effectiveness of CBT. RESULTS: Fatigue at T2 was predicted by a significant interaction between self-reported cognitive functioning and CBT. No interactions were found between other domains of quality of life, functioning, psychological distress and CBT. At T3, no significant difference on fatigue was found between CBT and usual care. Exploratory analyses showed that the difference nearly reached significance until 7 months postintervention. CONCLUSIONS: Patients who experienced more concentration and memory problems at T1 benefited more from CBT for fatigue and are indicators. After a year of follow-up, the effect of CBT for fatigue was no longer observed, and the effect on fatigue seemed to be diminished 7 months postintervention. The implication is that CBT for fatigue should be offered to patients with cancer with the highest chance to benefit.

Is increasing physical activity necessary to diminish fatigue during cancer treatment? Comparing cognitive behavior therapy and a brief nursing intervention with usual care in a multicenter randomized controlled trial.

BACKGROUND: Two interventions for fatigue were given during curative cancer treatment. The aim of this multicenter randomized controlled trial (RCT) with three conditions was to demonstrate the efficacy and to determine the contribution of physical activity. METHODS: Recruited from seven hospitals, 220 patients with various malignancies participated in a RCT. The brief nursing intervention (BNI) consisted of two 1-hour sessions, 3 months apart, given by 12 trained nurses, focusing only on physical activity. Cognitive behavior therapy (CBT) consisted of up to ten 1-hour sessions, within 6 months, provided by two therapists, focusing on physical activity and psychosocial elements. The control group received only usual care (UC). Assessments took place before and at least 2 months after cancer treatment, when patients had recovered from acute fatigue. Fatigue was the primary outcome. Efficacy was tested using analyses of covariance. A nonparametric bootstrap approach was used to test whether the effect on fatigue was mediated by physical activity. RESULTS: The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference was found in fatigue. The mediation hypothesis was rejected. DISCUSSION: CBT given during curative cancer treatment proved to be an effective intervention to reduce fatigue at least 2 months after cancer treatment. The BNI was not effective. Contrary to what was expected, physical activity did not mediate the effect of CBT on fatigue. Thus, the reduction in fatigue elicited by CBT was realized without a lasting increase in physical activity.