Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study.

BACKGROUND: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting. METHODS: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137. RESULTS: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period. CONCLUSIONS: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.

The association between age and long-term quality of life after curative treatment for prostate cancer: a cross-sectional study.

OBJECTIVE: We aimed to investigate the associations between age at radical prostate cancer treatment and long-term global quality of life (QoL), physical function (PF), and treatment-related side effects. MATERIAL AND METHODS: This single-center, cross-sectional study included men treated for localized prostate cancer with robotic-assisted radical prostatectomy (RARP) or external beam radiotherapy (EBRT) in 2014-2018. Global QoL and PF were assessed by the European Organisation of Research and Treatment in Cancer Quality of life Questionnaire-C30 (QLQ-C30), side effects by the Expanded Prostate Cancer Index Composite (EPIC-26). Adjusted linear regression models were estimated to assess associations between age (continuous variable) at treatment and outcomes. QLQ-C30 scores were compared to normative data after dividing the cohort in two groups, <70 years and ≥70 years at treatment. RESULTS: Of 654 men included, 516 (79%) had undergone RARP, and 138 (21%) had undergone EBRT combined with androgen deprivation therapy for 93%. Mean time since treatment was 57 months. Median age at treatment was 68 (min-max 44-84) years. We found no statistically significant independent association between age at treatment and global QoL, PF or side effects, except for sexual function (regression coefficient [RC] -0.77; p < 0.001) and hormonal/vitality (RC 0.30; p = 0.006) function. Mean QLQ-C30 scores were slightly poorer than age-adjusted normative scores, for men <70 years (n = 411) as well as for men ≥70 years (n = 243) at treatment, but the differences were not beyond clinical significance. CONCLUSIONS: In this cohort of prostate cancer survivors, age at treatment had little impact on long-term QoL and function. Due to the cross-sectional design, short term impact or variation over time cannot be ruled out.

Do older patients with colorectal cancer experience more deterioration in health-related quality of life than younger patients during the first year of palliative chemotherapy? A prospective real-world observational study.

INTRODUCTION: The primary aim was to evaluate changes in health-related quality of life (HRQoL) in a real-life population among younger (< 70 years) and older patients with metastatic colorectal cancer (mCRC) during the first year of palliative chemotherapy. The secondary aims were to assess the impact of chemo-break on HRQoL and to report overall survival (OS). MATERIALS AND METHODS: Patients with newly diagnosed mCRC, ≥ 18 years, and scheduled for first line palliative chemotherapy were included in this multicentre longitudinal observational study. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (0-100) was filled in at baseline and every second month. Changes or differences in QoL scores of >20, 10-20, and 5-10 points were considered to be of large, moderate, and small clinical magnitude, respectively. Comparing means of different QoL scores between groups or over time, a threshold of 5-10 was considered the minimally important difference (MID). Treatments, patient characteristics, and tumour characteristics were prospectively registered. RESULTS: A total of 214 patients were included, and 146 were alive after one year. Four months after start of treatment, large deteriorations in fatigue and physical functioning were reported by 40% and 25% of the patients, respectively. Changes in global QoL, physical functioning, role functioning, fatigue, pain, and nausea/vomiting were not significantly different between the age groups and reached baseline levels after one year. Patients on chemo-break reported significant improvements in several HRQoL domains. Median OS was 17.5 months [95% confidence interval 14.4-20.5] with no difference between younger and older patients. DISCUSSION: Older patients did not experience more deterioration in HRQoL than younger patients during the first year of palliative chemotherapy. Measures to mitigate the deteriorations in fatigue and physical functioning observed during the first months of palliative treatment are warranted. TRIAL REGISTRATION: NCT02395224, March 23, 2015, retrospectively registered.

Integrated Short-term Palliative Rehabilitation to improve quality of life and equitable care access in incurable cancer (INSPIRE): a multinational European research project.

Background: Disability related to incurable cancer affects over a million Europeans each year and people with cancer rank loss of function among the most common unmet supportive care needs. Objectives: To test the clinical and cost-effectiveness of an integrated short-term palliative rehabilitation intervention, to optimise function and quality of life in people affected by incurable cancer. Design: This is a multinational, parallel group, randomised, controlled, assessor blind, superiority trial. Methods: The INSPIRE consortium brings together leaders in palliative care, oncology and rehabilitation from partner organisations across Europe, with complementary expertise in health service research, trials of complex interventions, mixed-method evaluations, statistics and economics. Partnership with leading European civil society organisations ensures citizen engagement and dissemination at the highest level. We will conduct a multinational randomised controlled trial across five European countries, recruiting participants to assess the effectiveness of palliative rehabilitation for people with incurable cancer on the primary outcome - quality of life - and secondary outcomes including disability, symptom burden and goal attainment. To support trial conduct and enhance analysis of trial data, we will also conduct: comparative analysis of current integration of rehabilitation across oncology and palliative care services; mixed-method evaluations of equity and inclusivity, processes and implementation for the intervention, at patient, health service and health system levels. Finally, we will conduct an evidence synthesis, incorporating INSPIRE findings, and a Delphi consensus to develop an international framework for palliative rehabilitation practice and policy, incorporating indicators, core interventions, outcomes and integration methods. Scientific contribution: If positive, the trial could produce a scalable and equitable intervention to improve function and quality of life in people with incurable cancer and reduce the burden of care for their families. It could also upskill the practitioners involved and motivate future research questions. The intervention could be adapted and integrated into different health systems using existing staff and services, with little or no additional cost.

Diastolic function and cardiovascular risk among patients with severe obesity referred to a lifestyle-program - a pilot study.

Objectives. Severe obesity is associated with a high risk of comorbidities and alterations of cardiac structure and function. The primary aim of the study was to investigate the proportion of diastolic dysfunction (DD) at baseline, and changes in cardiac function from baseline (T1) to 6 months follow-up (T2) among participants with severe obesity attending a lifestyle-intervention. The secondary aim was to explore changes in body mass index (BMI), physical fitness (VO2peak) and cardiovascular risk from T1 to T2 and 12 months follow-up (T3).Design. This was an open single-site prospective observational study. Patients were recruited from an obesity clinic to a lifestyle-intervention consisting of three 3-weeks intermittent stays over 12-months period. Echocardiography was performed at T1 and T2 and BMI, VO2peak and cardiovascular risk measured at T1, T2 and T3.Results. Fifty-six patients were included (mean age 45.1 years; BMI 41.9). Six of 52 patients (12%) had grade 1 DD at T1, while five subjects had DD at T2. E/A ratio (11%, p = .005) and mitral deceleration time (9%, p = .014) were improved at T2. A reduction in BMI (-1.8, p < .001) and improvement in VO2peak (1.6 mL/kg min, p = .026) were assessed at T2 and this improvement persisted at T3. The total cardiovascular risk score was not significantly changed.Conclusion. The patients with severe obesity had low prevalence of DD. For all participants, an improvement in diastolic parameters, and an important initial weight loss was observed.Clinical Trial number: NCT02826122.

Geriatric impairments are associated with reduced quality of life and physical function in older patients with cancer receiving radiotherapy - A prospective observational study.

INTRODUCTION: Quality of life (QoL) and function are important outcomes for older adults with cancer. We aimed to assess differences in trends in patient-reported outcomes (PROs) during radiotherapy (RT) between (1) groups with curative or palliative treatment intent and (2) groups defined according to the number of geriatric impairments. MATERIALS AND METHODS: A prospective observational study including patients aged ≥65 years receiving curative or palliative RT was conducted. Geriatric assessment (GA) was performed before RT, and cut-offs for impairments within each domain were defined. Patients were grouped according to the number of geriatric impairments: 0, 1, 2, 3, and ≥ 4. Our primary outcomes, global QoL and physical function (PF), were assessed by The European Organisation for Research and Treatment of Cancer Quality-of-Life Core Questionnaire (EORTC) (QLQ-C30) at baseline, RT completion, and two, eight, and sixteen weeks later. Differences in trends in outcomes between the groups were assessed by linear mixed models. RESULTS: 301 patients were enrolled, mean age was 73.6 years, 53.8% received curative RT. Patients receiving palliative RT reported significantly worse global QoL and PF compared to the curative group. The prevalence of 0, 1, 2, 3 and ≥ 4 geriatric impairments was 16.6%, 22.7%, 16.9%, 16.3% and 27.5%, respectively. Global QoL and PF gradually decreased with an increasing number of impairments. These group differences remained stable from baseline throughout follow-up without any clinically significant changes for any of the outcomes. DISCUSSION: Increasing number of geriatric impairments had a profound negative impact on global QoL and PF, but no further decline was observed for any group or outcome, indicating that RT was mainly well tolerated. Thus, geriatric impairments per se should not be reasons for withholding RT. GA is key to identifying vulnerable patients in need of supportive measures, which may have the potential to improve treatment tolerance. Registered at clinicaltrials.gov (NCT03071640).

Community-Based Multidimensional Cancer Rehabilitation in Norway: A Feasibility Study.

BACKGROUND: Cancer survival is often accompanied by late effects that can be mitigated by tailored rehabilitation. In Norway, this has traditionally been offered as residential programs, whereas community-based cancer rehabilitation programs are lacking. OBJECTIVE: This study aimed to assess the feasibility and acceptability of a newly developed community-based multidimensional cancer rehabilitation program in Norway. METHODS: A feasibility study with a mixed methods explanatory sequential design was implemented. The intervention was a 12-week group-based rehabilitation program comprising 5 components: goal setting, physical exercise, psychoeducation, individual follow-up consultations, and peer support. Feasibility was assessed through recruitment, retention, and intervention delivery. Acceptability was assessed through intervention adherence and participant evaluation. Qualitative data were generated from focus group interviews. Statistical analyses were descriptive, and qualitative data were transcribed and analyzed using framework analyses. RESULTS: Sixty participants started, and 55 completed the 12-week rehabilitation program. The majority were female (80%), and the mean age was 56 years. The largest diagnostic group was breast cancer (42%). Retention was high (92%), as were adherence rates for all intervention components. The exercise component was rated the most beneficial, followed by individual consultations and peer support. Qualitative findings contributed to explaining the high adherence and positive evaluation. CONCLUSION: High retention, strong adherence, and positive evaluation imply that the community-based program was feasible and acceptable to cancer survivors. IMPLICATION FOR PRACTICE: The results will aid intervention refinement and contribute to a future randomized controlled trial to examine its effectiveness. If successful, the rehabilitation program could be implemented in the Norwegian Cancer Pathway "Home."

Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study.

About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients' impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient's care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients' impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.

Colorectal cancer patients' experiences with supervised exercise during adjuvant chemotherapy-A qualitative study.

BACKGROUND: Colorectal cancer (CRC) is a common cancer worldwide, with increasing numbers surviving and living with long-term side effects from treatment. Physical exercise during or after treatment may have several beneficial effects, but knowledge of CRC patients' reflections on exercising during adjuvant therapy is limited. The aim of this study was to explore the experiences of CRC patients participating in a supervised exercise program during adjuvant chemotherapy. METHODS: This study included CRC patients participating in two intervention studies with individually tailored and supervised combinations of endurance, resistance, and balance exercises during adjuvant chemotherapy. Semi-structured interviews performed at the beginning, during, and immediately after the intervention period from 15 participants were analyzed using thematic analysis. RESULTS: Four main themes identified were "structuring life with cancer," "motivation to exercise," "training experiences," and "effects of exercise." Scheduled appointments gave structure to daily life and served as an external motivational factor. The individual adjustments of exercise gave a sense of security and helped improving adherence, especially when feeling depressed or fatigued. Common expectations were improvement of endurance and strength and counteracting negative effects of chemotherapy. Experienced positive effects from exercising, both mentally and physically, contributed to inner motivation and inspired continued exercising after the study period. CONCLUSION: This study offers important insights into CRC patients' experiences of participating in a physical exercise program during adjuvant chemotherapy. Based on our findings, we recommend supervised and individually tailored physical exercise during adjuvant chemotherapy to this patient group.

ESPEN practical guideline: Clinical Nutrition in cancer.

BACKGROUND: This practical guideline is based on the current scientific ESPEN guidelines on nutrition in cancer patients. METHODS: ESPEN guidelines have been shortened and transformed into flow charts for easier use in clinical practice. The practical guideline is dedicated to all professionals including physicians, dieticians, nutritionists and nurses working with patients with cancer. RESULTS: A total of 43 recommendations are presented with short commentaries for the nutritional and metabolic management of patients with neoplastic diseases. The disease-related recommendations are preceded by general recommendations on the diagnostics of nutritional status in cancer patients. CONCLUSION: This practical guideline gives guidance to health care providers involved in the management of cancer patients to offer optimal nutritional care.

Exploring use of activity monitors for patients with obesity during weight-loss treatment - a qualitative study.

BACKGROUND: Obesity is a major health concern in western countries. In Norway, patients with obesity can attend weight-loss programmes, which focus on changes in dietary and physical activity habits. Use of self-monitoring is advocated when changing dietary and physical activity habits for adults with obesity. This study aimed to explore the experiences of patients with obesity who used activity monitors while attending a weight-loss programme. METHODS: Patients with body mass index (BMI) > 35 kg/m2 with weight related comorbidities or a BMI > 40 kg/m2 referred to an intermittent weight-loss programme were recruited into this study. They were introduced to one of three different activity monitors, Fitbit Zip™, Mio Fuse™, or Mio Slice™. Semi-structured interviews were performed with patients six months into the weight-loss programme. Thematic analysis was applied when analysing the data. RESULTS: Of the 29 informants (aged 21 to 66 years) interviewed, 59% were female. Their experience with activity monitors was related to their adherence to the weight-loss programme. Two main themes emerged from the informants stories: 1. "Activity monitors visualize proof of effort or failure to change health habits". 2. "Activity monitors act as a positive or negative enforcer when incorporating change". CONCLUSIONS: Using activity monitors either strengthens or undermines patients' attempts to change health habits when attending a weight-loss program. Our findings suggest a need for more individualized weight-loss programmes for patients with obesity.

Labor-force participation and working patterns among women and men who have survived cancer: A descriptive 9-year longitudinal cohort study.

AIMS: Our aim was to investigate labor-force participation, working hours, job changes, and education over 9 years among persons who have survived more than 10 years after cancer, and compare it to controls. METHODS: Register data on 2629 persons who survived cancer were stratified by gender and compared to data on 5258 matched controls. Persons who survived cancer were aged 30-50 when diagnosed with cancer and had a work contract prior to diagnosis. Descriptive analysis and t-tests were performed. RESULTS: The proportion of female persons who survived cancer in the labor force was reduced from 100% to 83.9% during follow-up, demonstrating a significant difference compared to controls for each year measured. The proportion of male persons who survived cancer dropped from 100% to 84.8%, but was only significantly different compared to controls in 2 years. The proportion of female persons who had survived cancer who worked full-time was lower in all years compared to both controls and male persons who survived cancer; in turn, male persons who had survived cancer worked full-time less than male controls. The proportion of female persons who had survived cancer who worked less than 20 hours per week increased compared to controls. The frequency of change of employer was higher among female persons who survived cancer compared to controls for some years, but no significant differences between male persons who survived cancer and controls were found. Female persons who survived cancer were in education more often than male persons who survived cancer. CONCLUSIONS: Persons who survived cancer experienced reduced labor-force participation and working hours 9 years after diagnosis, and the reduction was more pronounced for women than for men. Working patterns were also different between genders and between persons who survived cancer and controls.

Long-term work outcomes and the efficacy of multidisciplinary rehabilitation programs on labor force participation in cancer patients - a protocol for a longitudinal prospective cohort study.

Background. Many cancer survivors experience late effects of cancer treatment and therefore struggle to return to work. Norway provides rehabilitation programs to increase labor force participation for cancer survivors after treatment. However, the extent to which such programs affect labor force participation has not been appropriately assessed. This study aims to investigate i) labor force participation, sick leave and disability rates among cancer survivors up to 10 years after being diagnosed with cancer and identify comorbidities contributing to long-term sick leave or disability pensioning; ii) how type of cancer, treatment modalities, employment sectors and financial- and sociodemographic factors may influence labor force participation; iii) how participation in rehabilitation programs among cancer survivor affect the longterm labor force participation, the number of rehospitalizations and incidence of comorbidities. Design and methods. Information from four medical, welfare and occupational registries in Norway will be linked to information from 163,279 cancer cases (15.68 years old) registered in the Norwegian Cancer Registry from 2004 to 2016. The registries provide detailed information on disease characteristics, comorbidities, medical and surgical treatments, occupation, national insurance benefits and demographics over a 10-year period following a diagnosis of cancer. Expected impact of the study for Public Health. The study will provide important information on how treatment, rehabilitation and sociodemographic factors influence labor force participation among cancer survivors. Greater understanding of work-related risk factors and the influence of rehabilitation on work-participation may encourage informed decisions among cancer patients, healthcare and work professionals and service planners.

Exercise and Nutrition Interventions in Patients with Head and Neck Cancer during Curative Treatment: A Systematic Review and Meta-Analysis.

The aim of this meta-analysis was to examine the effects of nutritional and physical exercise interventions and interventions combining these interventions during radiotherapy treatment for patients with head and neck cancer on body composition, objectively measured physical function and nutritional status. Systematic electronic searches were conducted in MEDLINE (PubMed interface), EMBASE (Ovid interface), CINAHL (EBSCO interface) and Cochrane Library (Wiley interface). We identified 13 randomized controlled trials (RCTs) that included 858 patients. For body composition, using only nutrition as intervention, a significant difference between treatment and control group were observed (SMD 0.42 (95CI 0.23-0.62), p < 0.001). Only pilot RCTs investigated combination treatment and no significant difference between the treatment and control groups were found (SMD 0.21 (95CI -0.16-0.58), p = 0.259). For physical function, a significant difference between treatment and control group with a better outcome for the treatment group were observed (SMD 0.78 (95CI 0.51-1.04), p < 0.001). No effects on nutritional status were found. This meta-analysis found significantly positive effects of nutrition and physical exercise interventions alone in favor of the treatment groups. No effects in studies with combined interventions were observed. Future full-scaled RCTs combining nutrition and physical exercise is warranted.

Healthy Life Centres: a 3-month behaviour change programme's impact on participants' physical activity levels, aerobic fitness and obesity: an observational study.

OBJECTIVES: Individuals with low socioeconomic status and multimorbidity tend to have lower physical activity (PA) levels than the general population. Primary care is an important setting for reaching high-risk individuals to support behaviour change. This study aimed to investigate the impact of behaviour change interventions delivered by Norwegian Healthy Life Centres (HLCs) on participants' PA levels, aerobic fitness and obesity, and furthermore to investigate possible predictors of change. DESIGN: An observational study with a pre-post design and a 3-month follow-up. SETTING: Thirty-two HLCs in Norway were included. PARTICIPANTS: A total of 713 participants (72% of the participants included at baseline), 71% women, with a mean age of 51 (18-87 years) and body mass index (BMI) of 32 (SD 7) met to follow-up. INTERVENTION: Individual consultations and tailored individual and group-based exercise and courses organised by the HLCs and cooperating providers. OUTCOME MEASURES: The primary outcome was time spent in moderate to vigorous PA (MVPA, min/day) (ActiGraph GT3X+ accelerometer). The secondary outcomes were light PA (LPA, min/day), number of steps per day, time spent sedentary (SED, min/day), aerobic fitness (submaximal treadmill test, min), BMI (kg/m2) and waist circumference (WC, cm). RESULTS: There was no change in MVPA (B 1.4, 95% CI -0.4 to 3.1) after 3 months. The participants had improved LPA (4.0, 95% CI 0.5 to 7.5), increased number of steps (362, 95% CI 172 to 552), reduced SED (-5.6, 95% CI -9.8 to -1.3), improved fitness (0.8, 95% CI 0.6 to 1.0), reduced BMI (-0.2, 95% CI -0.1 to -0.3) and reduced WC (-1.7, 95% CI -2.0 to -1.3). Positive predictors of change were number of exercise sessions completed per week, duration of adherence to HLC offers and participation in exercise organised by HLC. CONCLUSION: Participation in the HLC interventions had small positive impacts on participants' PA levels, aerobic fitness and obesity. Further research to develop effective behaviour change programmes targeting individuals with complex health challenges is needed. TRIAL REGISTRATION NUMBER: NCT03026296.

Health-related quality of life and physical activity level after a behavior change program at Norwegian healthy life centers: a 15-month follow-up.

PURPOSE: The long-term impact of primary care behavior change programs on health-related quality of life (HRQoL) and physical activity (PA) level is unknown. The aim of this study was to investigate changes in HRQoL and PA among participants after a 3-month behavior change intervention at Norwegian healthy life center (HLCs) and at a 15-month follow-up. Furthermore, we aimed to study associations between changes in PA and HRQoL. METHODS: We followed 524 adult participants (18-83 years), recruited from 32 HLCs in August 2016-January 2018, who provided data on HRQoL (SF-36) and PA (ActiGraph accelerometers) 12 months after a 3-month behavior change intervention. Changes in HRQoL and PA between baseline, 3-month and 15-month follow-ups, and associations between changes in PA and HRQoL were analyzed by linear mixed models. RESULTS: All HRQoL dimensions improved from baseline to 3-month follow-up, and the improvements maintained at 15-month follow-up (mean 3.1-13.1 points, p < 0.001). PA increased from baseline to 3 months (mean 418 steps/day, p < 0.001), but declined from 3 to 15 months (mean - 371 steps/day, p < 0.001). We observed positive associations between changes in PA and HRQoL (0.84-3.23 points per 1000 steps/day, p < 0.023). CONCLUSIONS: Twelve months after completing a 3-month HLC intervention we found improved HRQoL, but not PA level. Still, there were positive associations between PA and HRQoL over this period, indicating that participants increasing their PA were more likely to improve their HRQoL.

Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program.

OBJECTIVE: Physical rehabilitation programs hold the potential to mitigate deterioration in health-related quality of life (HRQoL) in patients with head and neck cancer. The objective was to assess development in relevant domains of HRQoL following a physical exercise and nutrition intervention administrated during or after treatment. METHODS: In a pilot study, 41 patients were randomized to resistance training and oral nutritional supplements during (EN-DUR, n = 20) or after (EN-AF, n = 21) radiotherapy. Global health status/QoL (GHS) and physical functioning (PF) were measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire at baseline, week 6, and week 14. Differences between the groups were assessed by analysis of covariance. A difference of ≥10 points in GHS and PF was interpreted as clinically relevant. RESULTS: No statistically significant differences were detected between the groups; however, clinically relevant changes and differences in GHS and PF were observed. From baseline to week 6, GHS decreased 9 points in the EN-DUR group and 23 points in the EN-AF group and PF decreased 13 points and 21 points, respectively. From week 6 to week 14, GHS increased 14 points in the EN-DUR group and 26 points EN-AF group and PF did not change (0 points) in the EN-DUR group and increased 16 points in the EN-AF group. CONCLUSION: The findings from the present pilot study are promising and indicate that a physical rehabilitation program may have a positive impact on HRQoL during treatment and enhance recovery after treatment. A definitive randomized trial is warranted. LEVEL OF EVIDENCE: 1b-Individual randomized controlled trial.

Pulmonary Rehabilitation in Patients with Pulmonary Sarcoidosis: Impact on Exercise Capacity and Fatigue.

BACKGROUND: There is limited evidence regarding the impact of multidisciplinary pulmonary rehabilitation (PR) on exercise capacity and fatigue in patients with pulmonary sarcoidosis. The aim of this study was to evaluate the impact on exercise capacity and fatigue following PR, and to examine whether baseline fatigue was related to change in peak oxygen uptake (ΔV̇O2peak). METHODS: Forty-one patients with pulmonary sarcoidosis attending a 4-week inpatient PR program were recruited to this pre-post study. Both maximal exercise capacity, defined as V̇O2peak and measured with a cardiopulmonary exercise test, and fatigue, assessed with the Fatigue Assessment Scale (score 10-50 points), were measured before and after PR. RESULTS: There was a statistically significant improvement in V̇O2peak (1.2 ± 2.3 mL/kg/min, p = 0.002), and fatigue decreased significantly (-1.7 ± 3.9 points, p = 0.009) following PR. Unadjusted linear regression analyses demonstrated that age (B = -0.076, p = 0.017) and baseline fatigue (B = 0.196, p = 0.001) were predictors for change in V̇O2peak, while in adjusted analyses (age, sex, baseline V̇O2peak, baseline fatigue, and diffusion capacity of the lung for carbon monoxide), only baseline fatigue predicted change in V̇O2peak following PR (B = 0.165, p = 0.026). CONCLUSION: A 4-week multidisciplinary PR program improves maximal exercise capacity and reduces fatigue in patients with pulmonary sarcoidosis. Baseline fatigue only partly predicted change in V̇O2peak following PR.

The acute impact of resistance training on fatigue in patients with pulmonary sarcoidosis.

Fatigue is the most prevalent symptom among patients with sarcoidosis, and skeletal muscle dysfunction is a common clinical feature, making resistance training (RT) a recommended treatment strategy. Despite lacking knowledge regarding whether high-intensity RT will aggravate fatigue, low to moderate-intensity is routinely used even if the evidence for this protocol to improve muscle strength is inconclusive. This study aimed to investigate whether one single session of high-intensity RT induces a higher increase in fatigue than one single session of moderate-intensity RT. In this randomized crossover study, 41 patients with pulmonary sarcoidosis (age: 53 ± 11 yr) were recruited. They randomly performed one single session of high-intensity RT, 4 sets × 5 repetitions maximum (5RM), and one single session of moderate-intensity RT, 2 sets × 25 RM. Fatigue was assessed with the Visual Analogue Scale (0-100 mm) immediately before (T0), immediately after (T1) and 24 hours after (T2) each exercise session. Fatigue development from T0 to T1 was significantly lower after 5RM (-3 ± 18 mm) than after 25RM (5 ± 15 mm), p = 0.004. No difference was seen from T0 to T2 between 5RM (0 ± 17 mm) and 25RM (6 ± 18 mm), p = 0.147. The high-intensity 5RM session did not induce a larger increase in fatigue than the moderate-intensity 25RM session. RT appears feasible and safe in patients with pulmonary sarcoidosis irrespective of the intensity. Thus, the long-term effects of high-intensity RT on fatigue should be explored in a RT programme of longer duration.

Impact and implementation of Healthy Life Centres, a primary-care service intervention for behaviour change in Norway: Study design.

Aims: This ongoing study is investigating the implementation and long-term impact of Healthy Life Centres (HLCs), a primary-care service intervention for behaviour change in Norway. The primary aim is to study changes in objectively measured physical activity (PA) levels following a HLC intervention in the short (three months) and long term (15 months). Furthermore, the study is evaluating determinants concerning implementation and adaption of the HLC intervention that influence reach and impact on participants outcomes. Methods: This prospective observational study includes 32 HLCs from four different geographical regions in Norway. Subjects aged ⩾18 years were invited to participate. The study has a pre-post design with a 15-month follow-up. The HLC intervention is a three-month individualised program, containing personal consultations and group-based behaviour-specific courses on PA, diet and smoking cessation. Data collection consists of registration of objectively measured PA level, physical examinations, interviews and questionnaires. In addition, HLC organisation, offers, professions and resources are being examined. The Reach, Efficacy/Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework is being applied to study the external validation of the HLC intervention. The study enrolled 1020 participants who gave their written informed consent. Post-tests and follow-up data collection is still ongoing and will continue until August 2019. Conclusions: By exploring the HLC intervention in a real-world setting and addressing the elements of RE-AIM, this study will contribute to an improved understanding and development of effective primary-care behaviour interventions such as the HLC model. The strengths of the study are the large sample size and the many HLCs and regions included.