Dropout from exercise trials among cancer survivors-An individual patient data meta-analysis from the POLARIS study.

INTRODUCTION: The number of randomized controlled trials (RCTs) investigating the effects of exercise among cancer survivors has increased in recent years; however, participants dropping out of the trials are rarely described. The objective of the present study was to assess which combinations of participant and exercise program characteristics were associated with dropout from the exercise arms of RCTs among cancer survivors. METHODS: This study used data collected in the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) study, an international database of RCTs investigating the effects of exercise among cancer survivors. Thirty-four exercise trials, with a total of 2467 patients without metastatic disease randomized to an exercise arm were included. Harmonized studies included a pre and a posttest, and participants were classified as dropouts when missing all assessments at the post-intervention test. Subgroups were identified with a conditional inference tree. RESULTS: Overall, 9.6% of the participants dropped out. Five subgroups were identified in the conditional inference tree based on four significant associations with dropout. Most dropout was observed for participants with BMI >28.4 kg/m2 , performing supervised resistance or unsupervised mixed exercise (19.8% dropout) or had low-medium education and performed aerobic or supervised mixed exercise (13.5%). The lowest dropout was found for participants with BMI >28.4 kg/m2 and high education performing aerobic or supervised mixed exercise (5.1%), and participants with BMI ≤28.4 kg/m2 exercising during (5.2%) or post (9.5%) treatment. CONCLUSIONS: There are several systematic differences between cancer survivors completing and dropping out from exercise trials, possibly affecting the external validity of exercise effects.

Moderators of exercise effects on self-reported cognitive functioning in cancer survivors: an individual participant data meta-analysis.

PURPOSE: This individual participant data meta-analysis (IPD-MA) assesses exercise effects on self-reported cognitive functioning (CF) and investigates whether effects differ by patient-, intervention-, and exercise-related characteristics. METHODS: IPD from 16 exercise RCTs, including 1987 patients across multiple types of non-metastatic cancer, was pooled. A one-stage IPD-MA using linear mixed-effect models was performed to assess exercise effects on self-reported CF (z-score) and to identify whether the effect was moderated by sociodemographic, clinical, intervention- and exercise-related characteristics, or fatigue, depression, anxiety, and self-reported CF levels at start of the intervention (i.e., baseline). Models were adjusted for baseline CF and included a random intercept at study level to account for clustering of patients within studies. A sensitivity analysis was performed in patients who reported cognitive problems at baseline. RESULTS: Minimal significant beneficial exercise effects on self-reported CF (ß=-0.09 [-0.16; -0.02]) were observed, with slightly larger effects when the intervention was delivered post-treatment (n=745, ß=-0.13 [-0.24; -0.02]), and no significant effect during cancer treatment (n=1,162, ß=-0.08 [-0.18; 0.02]). Larger effects were observed in interventions of 12 weeks or shorter (ß=-0.14 [-0.25; -0.04]) or 24 weeks or longer (ß=-0.18 [-0.32; -0.02]), whereas no effects were observed in interventions of 12-24 weeks (ß=0.01 [-0.13; 0.15]). Exercise interventions were most beneficial when provided to patients without anxiety symptoms (ß=-0.10 [-0.19; -0.02]) or after completion of treatment in patients with cognitive problems (ß=-0.19 [-0.31; -0.06]). No other significant moderators were identified. CONCLUSIONS: This cross-cancer IPD meta-analysis observed small beneficial exercise effects on self-reported CF when the intervention was delivered post-treatment, especially in patients who reported cognitive problems at baseline. IMPLICATIONS FOR CANCER SURVIVORS: This study provides some evidence to support the prescription of exercise to improve cognitive functioning. Sufficiently powered trials are warranted to make more definitive recommendations and include these in the exercise guidelines for cancer survivors.

Trajectories of fatigue in cancer patients during psychological care.

OBJECTIVE: Psycho-oncological institutions offer specialized care for cancer patients. Little is known how this care might impact fatigue. This study aimed to identify fatigue trajectories during psychological care, examined factors distinguishing these trajectories and predicted fatigue severity after nine months of psychological care. DESIGN: Naturalistic, longitudinal study of 238 cancer patients receiving psycho-oncological care in the Netherlands. Data were collected before initiation of psychological care (T1) and three (T2) and nine months (T3) afterwards. Latent class growth analysis, repeated measure analyses (RMA) and linear regression analysis were performed. MAIN OUTCOME MEASURES: Fatigue severity: Checklist Individual Strength. RESULTS: Three fatigue trajectories were identified: high- (30%), moderate- (62%) and low-level fatigue (8%). While statistically significant decreases in fatigue were found, this decrease was not clinically relevant. RMA showed main effects for time for fatigue trajectories on depression, anxiety, personal control and illness cognitions. Fatigue severity and physical symptoms at T1, but not demographic or clinical factors, were predictive of fatigue severity at T3. CONCLUSIONS: Fatigue is very common during psycho-oncological care, and notably not clinically improving. As symptoms of fatigue, depression, anxiety and physical symptoms often cluster, supplementary fatigue treatment should be considered when it is decided to treat other symptoms first.

Distress and mental health care and medication use among survivors of multiple primary cancer diagnoses: Findings from the 2016 National Health Interview Survey.

OBJECTIVE: Over 1 million survivors of multiple primary cancer (MPC) diagnoses reside in the USA. Information regarding their physical and mental health status is limited. This study examined distress and mental health care use among MPC survivors relative to survivors of a single primary cancer (SPC) diagnosis. METHODS: Using the 2016 National Health Information Survey, MPC survivors (n = 265), SPC survivors (n = 2103), and no cancer controls (NCC; n = 28,320) were identified. The MPC group was compared to the SPC and NCC groups with regard to multiple distress indices and use of mental health care and anxiety and depression medication. RESULTS: Relative to the SPC group, the MPC group reported more Total Distress (M = 9.59 vs. 8.84; p < .001), and were more likely to report daily or weekly anxiety feelings (OR = 2.07; p < .001), meet criteria for serious psychological distress (OR = 1.49; p = .02) and have talked to a mental health professional (OR = 1.75; p = .01). Comparison of MPC and NweCC groups yielded similar results. The MPC group did not differ from the SPC or NCC groups in severity of anxiety or depression feelings, distress interference, or anxiety and depression medication use. CONCLUSIONS: MPC survivors reported greater distress relative to SPC survivors. The clinical significance of this greater distress is unclear, however. While MPC survivors were more likely to have talked to a mental health professional, uptake of mental health care appeared to be suboptimal. MPC and SPC survivors might be considered distinct subgroups and increased attention devoted to potentially unique mental and physical health needs of MPC survivors.

Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

OBJECTIVE: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer. METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008). RESULTS: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: ß = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: ß = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (ß = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (ß = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (ß = -0.85 [95%CI = -1.40; -0.30]). CONCLUSIONS: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.

Moderators of Exercise Effects on Cancer-related Fatigue: A Meta-analysis of Individual Patient Data.

PURPOSE: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCT) to investigate moderators of exercise intervention effects on cancer-related fatigue. METHODS: We used individual patient data from 31 exercise RCT worldwide, representing 4366 patients, of whom 3846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue (z score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test. RESULTS: Exercise interventions had statistically significant beneficial effects on fatigue (ß = -0.17; 95% confidence interval [CI], -0.22 to -0.12). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (ßdifference = -0.18; 95% CI -0.28 to -0.08). Supervised interventions with a duration ≤12 wk showed larger effects on fatigue (ß = -0.29; 95% CI, -0.39 to -0.20) than supervised interventions with a longer duration. CONCLUSIONS: In this individual patient data meta-analysis, we found statistically significant beneficial effects of exercise interventions on fatigue, irrespective of demographic and clinical characteristics. These findings support a role for exercise, preferably supervised exercise interventions, in clinical practice. Reasons for differential effects in duration require further exploration.

Pace and determinants of implementation of the self-management of well-being group intervention: a multilevel observational study.

BACKGROUND: When implementing an empirically supported intervention (ESI) arrays of influencing factors operate on the professional and organizational level, but so far dependency between these levels has often been ignored. The aim of this study is to describe the pace and identify determinants of implementation of the Self-Management of Well-being (SMW) group intervention while taking the dependency between professionals and organizations into account. METHODS: Pace of implementation was measured as the time between training of professionals and first use of the SMW intervention in months. Determinants of first use were derived from the Fleuren framework and assessed using web-based questionnaires and telephone interviews. First, univariate analyses, Fisher's exact tests and t-tests, were performed to identify determinants of first use of the SMW intervention on the individual professional and the organizational level independently. Second, multilevel analyses were performed to correct for the dependency between professionals and organizations. Simple multilevel logistic regression analyses were performed with determinants found significant in the univariate analyses as independent variables, first use as dependent variable, professionals entered in the first level, and organizations in the second level. RESULTS: Forty-eight professionals from 18 organizations were trained to execute the SMW intervention. Thirty-two professionals achieved first use, at a mean pace of 7.5 months ± 4.2. Determinants on the professional level were 'ownership', 'relative advantage', 'support from colleagues' and 'compatibility'. Determinants on the organizational level were 'organizational size' and 'innovation-task orientation fit'. Multilevel analysis showed that 'compatibility', a factor on the professional level, was the only significant determinant contributing to first use in the multilevel model. CONCLUSIONS: This implementation study revealed a strong dependency between professionals and organizations. Results showed that a majority of professionals used the SMW intervention in about 8 months. When the dependency between professionals and organization was taken into account, the professionals' perception of compatibility was the only remaining determinant of implementation on the professional level. Organizational size and managers' perception of 'innovation-task orientation fit' were determinants of implementation on the organizational level. It is advisable to discuss the compatibility between new and current tasks among managers and professionals before adopting a new intervention.

Targeting Exercise Interventions to Patients With Cancer in Need: An Individual Patient Data Meta-Analysis.

Background: Exercise effects in cancer patients often appear modest, possibly because interventions rarely target patients most in need. This study investigated the moderator effects of baseline values on the exercise outcomes of fatigue, aerobic fitness, muscle strength, quality of life (QoL), and self-reported physical function (PF) in cancer patients during and post-treatment. Methods: Individual patient data from 34 randomized exercise trials (n = 4519) were pooled. Linear mixed-effect models were used to study moderator effects of baseline values on exercise intervention outcomes and to determine whether these moderator effects differed by intervention timing (during vs post-treatment). All statistical tests were two-sided. Results: Moderator effects of baseline fatigue and PF were consistent across intervention timing, with greater effects in patients with worse fatigue (Pinteraction = .05) and worse PF (Pinteraction = .003). Moderator effects of baseline aerobic fitness, muscle strength, and QoL differed by intervention timing. During treatment, effects on aerobic fitness were greater for patients with better baseline aerobic fitness (Pinteraction = .002). Post-treatment, effects on upper (Pinteraction < .001) and lower (Pinteraction = .01) body muscle strength and QoL (Pinteraction < .001) were greater in patients with worse baseline values. Conclusion: Although exercise should be encouraged for most cancer patients during and post-treatments, targeting specific subgroups may be especially beneficial and cost effective. For fatigue and PF, interventions during and post-treatment should target patients with high fatigue and low PF. During treatment, patients experience benefit for muscle strength and QoL regardless of baseline values; however, only patients with low baseline values benefit post-treatment. For aerobic fitness, patients with low baseline values do not appear to benefit from exercise during treatment.

Is fatigue a disease-specific or generic symptom in chronic medical conditions?

OBJECTIVE: Severe fatigue is highly prevalent in various chronic diseases. Disease-specific fatigue models have been developed, but it is possible that fatigue-related factors in these models are similar across diseases. The purpose of the current study was to determine the amount of variance in fatigue severity explained by: (a) the specific disease, (b) factors associated with fatigue across different chronic diseases (transdiagnostic factors), and (c) the interactions between these factors and specific diseases. METHOD: Data from 15 studies that included 1696 patients with common chronic diseases and disorders that cause long-term disabilities were analyzed. Linear regression analysis with the generalized least-squares technique was used to determine fatigue-related factors associated with fatigue severity, that is, demographic variables, health-related symptoms and psychosocial variables. RESULTS: Type of chronic disease explained 11% of the variance noted in fatigue severity. The explained variance increased to 55% when the transdiagnostic factors were added to the model. These factors were female sex, age, motivational and concentration problems, pain, sleep disturbances, physical functioning, reduced activity and lower self-efficacy concerning fatigue. The predicted variance increased to 61% when interaction terms were added. Analysis of the interactions revealed that the relationship between fatigue severity and relevant predictors mainly differed in strength, not in direction. CONCLUSIONS: Fatigue severity can largely be explained by transdiagnostic factors; the associations vary between chronic diseases in strength and significance. This suggests that severely fatigued patients with different chronic diseases can probably benefit from a transdiagnostic fatigue-approach which focuses on individual patient needs rather than a specific disease. (PsycINFO Database Record

The efficacy of Internet-based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial.

BACKGROUND: Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU). METHODS: The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis). RESULTS: Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8). CONCLUSIONS: ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society.

Web-based cognitive behavioural therapy blended with face-to-face sessions for chronic fatigue in type 1 diabetes: a multicentre randomised controlled trial.

BACKGROUND: Fatigue in type 1 diabetes is prevalent and persistent, but so far, no evidence-based treatments are available. We aimed to investigate the efficacy of cognitive behavioural therapy (CBT) in reducing fatigue severity in patients with type 1 diabetes. METHODS: We did a multicentre randomised controlled trial at one university medical centre and four large teaching hospitals in the Netherlands. Eligible patients were aged 18-70 years and had type 1 diabetes for at least 1 year and chronic fatigue for at least 6 months. We randomly assigned patients (1:1) to CBT or waiting list using computer-generated blocked randomisation, stratified by type of enrolment. The CBT intervention (Dia-Fit) was given for 5 months in blended form, consisting of face-to-face and web-based sessions. The primary outcome was fatigue severity assessed 5 months after randomisation, directly after the intervention or waiting list period, with the Checklist Individual Strength fatigue severity subscale. Secondary outcomes were functional impairment (assessed with the total score of the Sickness Impact Profile-8), glycaemic control (HbA1c), and glucose variability. Analyses were done by intention to treat. This trial is registered with the Nederlands Trial Register, number NTR4312. FINDINGS: Between Feb 6, 2014, and March 24, 2016, we randomly assigned 120 eligible patients to either CBT (n=60) or waiting list (n=60), all of whom were included in the intention-to-treat analyses. Compared with patients in the waiting list group, those in the CBT group had significantly lower fatigue severity scores (mean difference 13·8, 95% CI 10·0-17·5; p<0·0001) and significantly lower scores for functional impairment (mean difference 513, 95% CI 340-686; p<0·0001) after 5 months. HbA1c and glucose variability did not change after treatment and there was no difference between groups. Five patients in the CBT group and seven in the waiting list group reported adverse events; none were deemed to be related to the study intervention. INTERPRETATION: Although our findings need to be confirmed in larger and longer-term studies, they suggest that CBT can effectively reduce fatigue severity and functional impairment in type 1 diabetes. FUNDING: Dutch Diabetes Research Foundation (Diabetes Fonds).

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.

Sustaining program effectiveness after implementation: The case of the self-management of well-being group intervention for older adults.

OBJECTIVE: The Self-Management of Well-being (SMW) group intervention for older women was implemented in health and social care. Our aim was to assess whether effects of the SMW intervention were comparable with the original randomized controlled trial (RCT). Furthermore, we investigated threats to effectiveness, such as participant adherence, group reached, and program fidelity. METHODS: In the implementation study (IMP) 287 and RCT 142 women participated. We compared scores on self-management ability and well-being of the IMP and RCT. For adherence, drop-out rates and session attendance were compared. Regarding reach, we compared participants' baseline characteristics. Professionals completed questions regarding program fidelity. RESULTS: No significant differences were found on effect outcomes and adherence between IMP and RCT (all p≥0.135). Intervention effect sizes were equal (0.47-0.59). IMP participants were significantly less lonely and more likely to be married, but had lower well-being. Most professionals followed the protocol, with only minimal deviations. CONCLUSION: The effectiveness of the SMW group intervention was reproduced after implementation, with similar participant adherence, minimal changes in the group reached, and high program fidelity. PRACTICE IMPLICATIONS: The SMW group intervention can be transferred to health and social care without loss of effectiveness. Implementation at a larger scale is warranted.

Effects and moderators of exercise on quality of life and physical function in patients with cancer: An individual patient data meta-analysis of 34 RCTs.

This individual patient data meta-analysis aimed to evaluate the effects of exercise on quality of life (QoL) and physical function (PF) in patients with cancer, and to identify moderator effects of demographic (age, sex, marital status, education), clinical (body mass index, cancer type, presence of metastasis), intervention-related (intervention timing, delivery mode and duration, and type of control group), and exercise-related (exercise frequency, intensity, type, time) characteristics. Relevant published and unpublished studies were identified in September 2012 via PubMed, EMBASE, PsycINFO, and CINAHL, reference checking and personal communications. Principle investigators of all 69 eligible trials were requested to share IPD from their study. IPD from 34 randomised controlled trials (n=4519 patients) that evaluated the effects of exercise compared to a usual care, wait-list or attention control group on QoL and PF in adult patients with cancer were retrieved and pooled. Linear mixed-effect models were used to evaluate the effects of the exercise on post-intervention outcome values (z-score) adjusting for baseline values. Moderator effects were studies by testing interactions. Exercise significantly improved QoL (ß=0.15, 95%CI=0.10;0.20) and PF (ß=0.18, 95%CI=0.13;0.23). The effects were not moderated by demographic, clinical or exercise characteristics. Effects on QoL (ßdifference_in_effect=0.13, 95%CI=0.03;0.22) and PF (ßdifference_in_effect=0.10, 95%CI=0.01;0.20) were significantly larger for supervised than unsupervised interventions. In conclusion, exercise, and particularly supervised exercise, effectively improves QoL and PF in patients with cancer with different demographic and clinical characteristics during and following treatment. Although effect sizes are small, there is consistent empirical evidence to support implementation of exercise as part of cancer care.

Severe fatigue in type 1 diabetes: Exploring its course, predictors and relationship with HbA1c in a prospective study.

AIMS: To prospectively identify the course of severe fatigue, its predictors and the relationship with HbA1c in patients with type 1 diabetes. METHODS: 214 adult patients completed questionnaires on fatigue severity and fatigue-related factors at baseline. HbA1c was retrieved from medical records. After 43months, fatigue severity and HbA1c were reassessed in 194 patients. A logistic regression analysis was used to determine predictors of severe fatigue at follow-up with various cognitive-behavioral and clinical factors as potential predictors. The relationship between fatigue and HbA1c was investigated in a sub-analysis by differentiating between patients with suboptimal glucose control [HbA1c>7% (53mmol/mol)] and optimal glucose control [HbA1c⩽7% (53mmol/mol)]. RESULTS: The prevalence of severe fatigue was 40% at baseline and 42% at follow-up. In three out of four severely fatigued patients at baseline (76%), severe fatigue persisted over time. More depressive symptoms, more pain, sleep disturbances, lower self-efficacy concerning fatigue, less confidence in diabetes self-care, more fatigue severity at baseline and more diabetes complications predicted severe fatigue at follow-up. Over time, HbA1c at baseline was positively associated with fatigue severity at follow-up in both groups (suboptimal glucose control: r=.18, p<.05; optimal glucose control: r=.09, p<.05). CONCLUSIONS: About three quarters of fatigued[corrected] patients with type 1 diabetes suffer from persistent fatigue. Aside from the number of diabetes complications, no clinical factors explained the persistence of fatigue. HbA1c and fatigue were weakly associated in a sub-analysis. Since the strongest predictors of severe fatigue were cognitive-behavioral factors, behavioral interventions might be effective in decreasing fatigue.

Fatigue screening in breast cancer patients: identifying likely cases of cancer-related fatigue.

OBJECTIVE: For clinical and research purposes, efficient identification of cases of cancer-related fatigue (CRF) is important, as CRF can be persistent and interfere with usual functioning. While various fatigue-screening instruments are available, no brief screening indices have been developed using formally diagnosed CRF cases as the criterion. METHODS: Breast cancer patients (n = 385) completed a fatigue diagnostic interview and self-report fatigue measures (Profile of Mood States-fatigue subscale, Fatigue Symptom Inventory, and SF-36 vitality subscale), after initial adjuvant therapy (post-treatment (post-Tx) 1 assessment), after completion of radiotherapy for women receiving chemotherapy + radiotherapy (post-Tx 2 assessment), and 6 months after completion of all adjuvant therapy (6-month post-Tx assessment). CRF cases were identified using specific diagnostic criteria. ROC analyses identified screening indices, which could accurately identify CRF cases after initial adjuvant therapy. Screening indices were cross-validated using post-Tx 2 and 6-month follow-up assessment data. RESULTS: A total of 104 women (27%) met CRF criteria after initial adjuvant therapy. Six two-item screening indices were identified. For all indices, area under the curve exceeded 0.80, sensitivity exceeded 0.80, and specificity exceeded 0.57. Cross-validation suggested that, except for the index based on SF-36, all the indices continued to accurately identify CRF cases at the post-Tx 2 and 6-month post-Tx assessments. Overall, a two-item composite index based on Fatigue Symptom Inventory 'most severity' and 'work interference' items performed best. CONCLUSIONS: Breast cancer patients and survivors meeting CRF diagnostic criteria can be accurately identified using brief screening indices derived from common self-report fatigue measures.

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.

Identifying the determinants of use of the G&G interventions for older adults in health and social care: protocol of a multilevel approach.

BACKGROUND: Despite aging-related losses, many older adults are able to maintain high levels of subjective well-being. However, not all older adults are able to self-manage and adapt. The GRIP&GLEAM [Dutch: GRIP&GLANS] (G&G) interventions have shown to significantly improve self-management ability, well-being and loneliness in older adults. Actual use of the evidence-based G&G interventions, however, remains limited as long as the interplay between implementation factors at different hierarchical stakeholder levels is poorly understood. The aim of the study is to identify the determinants of successful implementation of the G&G interventions. METHODS/DESIGN: The study is performed in health and social care organizations in the northern part of the Netherlands. The degree of implementation success is operationalized by four parameters: use (yes/no), pace (time to initial use), performance (extent of use) and prolongation (intention to continue use). Based on the Fleuren model, factors at four hierarchical stakeholder levels (i.e. target group, professionals, organizations and financial-political context) are assessed at three measurement points in 2 years. The nested data are analyzed applying multilevel modeling techniques. DISCUSSION: In this study, health and social care organizations are considered to be part of multilevel functional systems, in which factors at different hierarchical stakeholder levels impede or facilitate use of the G&G interventions. Strengths of the study are the multifaceted measurement of use, and the multilevel approach in identifying the determinants. The study will contribute to the development of ecologically valid implementation strategies of the G&G interventions and comparable evidence-based practices.

A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial.

BACKGROUND: Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective treatment available for chronic fatigue in patients with type 1 diabetes. Cognitive behaviour therapy aimed at cognitions and behaviours that perpetuate fatigue is effective in reducing fatigue in other chronic diseases. Recent research showed that these cognitions and behaviours are also potential determinants of fatigue in type 1 diabetes. We designed Dia-Fit, a web-based cognitive behaviour therapy for severe and chronic fatigue in patients with type 1 diabetes. This patient-tailored intervention is aimed at reducing fatigue by changing cognitions and behaviours assumed to maintain fatigue. The efficacy of Dia-Fit will be investigated in this study. METHODS/DESIGN: A randomised controlled trial will be conducted in 120 patients with type 1 diabetes who are chronically and severely fatigued. Patients will be randomised to a treatment or waiting list group. The treatment group will receive Dia-Fit, a blended care therapy consisting of up to eight internet modules and face-to-face sessions with a therapist during a five-month period. The treatment will be tailored to the fatigue-maintaining cognitions and behaviours that are relevant for the patient and are determined at baseline. The waiting list group will receive Dia-Fit after a waiting period of five months. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment and glucose control determined by haemoglobin A1c and blood glucose variability. DISCUSSION: To our knowledge, this is the first study investigating the efficacy of a cognitive behavioural intervention for chronic fatigue in patients with type 1 diabetes. TRIAL REGISTRATION: Dutch trial register NTR4312 (10 December 2013).