Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

BACKGROUND: Multimodal prehabilitation is a promising adjunct to the current surgical treatment pathway for colorectal cancer patients to further improve postoperative outcomes, especially for high-risk patients with low functional capacity. The aim of the present study was to test the effect of prehabilitation on immediate postoperative recovery. METHOD: The study was designed as a RCT with two arms (intervention and control). The intervention consisted of 4 weeks of multimodal prehabilitation, with supervised physical training, nutritional support and medical optimization. The control group received standard of care. A total of 40 patients with colorectal cancer (WHO performance status I or II) undergoing elective surgery with curative intent were included. The primary outcome was postoperative recovery within the first 3 postoperative days, measured by Quality of Recovery-15, a validated questionnaire with a scoring range between 0 and 150 and a minimal clinically relevant difference of 8. RESULTS: In total, 36 patients were analysed with 16 in the intervention group and 20 in the control group. The mean age of the included patients was 79 years. The overall treatment effect associated with the intervention was a 21.9 (95% c.i. 4.5-39.3) higher quality of recovery-15 score during the first 3 postoperative days compared to control, well above the minimal clinically relevant difference. CONCLUSION: Four weeks of multimodal prehabilitation prior to elective curative intended colorectal cancer surgery in patients with WHO performance status I or II was associated with a clinically relevant improvement in postoperative recovery.Registration number: NCT04167436 (http://www.clinicaltrials.gov).

Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention.

We developed the Navigate intervention to improve survival among vulnerable lung cancer patients. In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial. The Navigate intervention includes nurse navigation, patient-reported outcomes, and physical exercise. Patients ≥ 18 years old, diagnosed with non-small cell lung cancer at any stage, with performance status ≤ 2, eligible for cancer treatment and vulnerable according to a screening instrument were included. The recruitment goal of eligible patients was 40% while the retention goal was 85%. The predefined cut-offs for sufficient attendance and adherence were ≥ 75%. Acceptability was evaluated by semi-structured interviews with participants, nurse navigators, and physiotherapists. Seventeen (56%) out of 30 screened patients were considered vulnerable and eligible for the study, 14 (82%) accepted participation, and 3 (21%) were subsequently excluded due to ineligibility, leaving 11 patients. Four patients dropped out (36%) and four patients died (36%) during follow-up and 3 (27%) were retained. All 11 patients participated in nurse sessions (mean 16, range 1-36) with 88% attendance and dialogue tools being applied in 68% of sessions. Ninety-one percent of patients responded to PROs (mean of 9 PROs, range 1-24) with 76% of the PRO questionnaires used (attendance) and 100% adherence (completion of all questions in PRO questionnaires), and 55% participated in exercise sessions with 58% attendance and 85% adherence. We identified important barriers primarily related to transportation, but overall acceptability was high. The Navigate intervention was feasible with high participation, acceptability and satisfactory adherence. Retention and exercise attendance were low, which resulted in adjustments.Trial registration: The feasibility study was initiated prior to the multicenter randomized controlled trial registered by ClinicalTrials.gov (number: NCT05053997; date 23/09/2021).

Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer.

BACKGROUND: Prehabilitation with exercise interventions during neoadjuvant chemotherapy (NACT) is effective in reducing physical and psychosocial chemotherapy-related adverse events in patients with cancer. In preclinical studies, data also support a growth inhibitory effect of aerobic exercise on the tumour microenvironment with possible improved chemotherapy delivery but evidence in human patients is limited. The aim of the study here described is to investigate if supervised exercise with high-intensity aerobic and resistance training during NACT can improve tumour reduction in patients with breast cancer. METHODS: This parallel two-armed randomized controlled trial is planned to include 120 women aged ≥ 18 years with newly diagnosed breast cancer starting standard NACT at a university hospital in Denmark (a total of 90 participants needed according to the power calculation and allowing 25% (n = 30) dropout). The participants will be randomized to usual care or supervised exercise consisting of high-intensity interval training on a stationary exercise bike and machine-based progressive resistance training offered three times a week for 24 weeks during NACT, and screening-based advice to seek counselling in case of moderate-severe psychological distress (Neo-Train program). The primary outcome is tumour size change (maximum diameter of the largest lesion in millimetre) measured by magnetic resonance imaging prior to surgery. Secondary outcomes include clinical/pathological, physical and patient-reported measures such as relative dose intensity of NACT, hospital admissions, body composition, physical fitness, muscle strength, health-related quality of life, general anxiety, depression, and biological measures such as intratumoural vascularity, tumour infiltrating lymphocytes, circulating tumour DNA and blood chemistry. Outcomes will be measured at baseline (one week before to 1-2 weeks after starting NACT), during NACT (approximately week 7, 13 and 19), pre-surgery (approximately week 21-29), at surgery (approximately week 21-30) and 3 months post-surgery (approximately 33-42 weeks from baseline). DISCUSSION: This study will provide novel and important data on the potential benefits of supervised aerobic and resistance exercise concomitant to NACT on tumour response and the tumour microenvironment in patients with breast cancer, with potential importance for survival and risk of recurrence. If effective, our study may help increase focus of exercise as an active part of the neoadjuvant treatment strategy. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT04623554) on November 10, 2020.

NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial.

INTRODUCTION AND AIM: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer. METHODS AND ANALYSIS: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests. ETHICS AND DISSEMINATION: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05053997.

Dropout during a 12-week transitional exercise-based cardiac rehabilitation programme: a mixed-methods prospective cohort study.

AIMS: Investigate the dropout rate during a 12-week transitional exercise-based cardiac rehabilitation (exCR) programme focusing on a halfway transition phase between hospital and the municipality-based cardiac rehabilitation. Secondly, investigate patient characteristics associated with dropout at the transition. METHODS AND RESULTS: Patients with coronary heart disease, heart failure, or heart valve surgery referred to exCR were included in a prospective cohort study conducted between 1 March 2018 and 28 February 2019 at Zealand University Hospital. Exercise-based cardiac rehabilitation was initiated at the hospital with a halfway transitional to local healthcare centres in the municipalities. Dropouts were identified every third week through telephone interviews. A Kaplan-Meier time-to-event analysis was used to investigate time to dropout, while multiple logistic regression assessed associations between patient characteristics and dropout at the transition. Of 560 patients eligible for exCR, 279 participated in the study. Fourteen patients were lost to follow-up and 103 dropped out, resulting in a dropout rate of 39% [95% confidence interval (CI) 33-45%]. Of the 103 dropouts, 72 patients (70%) dropped out at the transition. In the adjusted analysis, patients attached to the labour market were associated with dropout at the transition [odds ratio (OR) = 6.31 (95% CI 2.04-19.54)]. Furthermore, odds of dropping out at transition were reduced for each extra exercise session attended [OR = 0.79 (95% CI 0.66-0.94)]. CONCLUSION: The transition phase constitutes a critical dropout period in exCR, in which increased attention on patient adherence is needed. In clinical practice, communication and strategies addressing patient retention across settings could be essential to prevent dropout in transitional exCR.

The association between clusters of chronic conditions and psychological well-being in younger and older people-A cross-sectional, population-based study from the Lolland-Falster Health Study, Denmark.

AIM: To investigate the association between clusters of conditions and psychological well-being across age groups. METHOD: This cross-sectional study used data collected in the Danish population-based Lolland-Falster Health Study. We included adults over the age of 18 years. Self-reported chronic conditions were divided into 10 groups of conditions. The primary outcome was psychological well-being (the WHO-5 Well-Being Index). Factor analysis constructed the clusters of conditions, and regression analysis investigated the association between clusters and psychological well-being. RESULTS: Of 10,781 participants, 31.4% were between 18 and 49 years, 35.7% were between 50 and 64 years and 32.9% were above ≥65 years. 35.2% had conditions represented in 1 and 32.9% in at least 2 of 10 condition groups. Across age groups, living with one or more chronic conditions was associated with poorer psychological well-being. Two chronic condition patterns were identified; one comprised cardiovascular, endocrine, kidney, musculoskeletal and cancer conditions, the second mental, lung, neurological, gastrointestinal and sensory conditions. Both patterns were associated with poorer psychological well-being (Pattern 1: -4.5 (95% CI: -5.3 to -3.7), Pattern 2: -9.1 (95% CI -13.8 to -8.2). For pattern 2, participants ≥65 years had poorer psychological well-being compared to younger (-12.6 (95% CI -14.2 to -11.0) vs -6.6 (95% CI: -7.8 to -5.4) for 18-49 years and -8.7 (95% CI: -10.1 to -7.3) for 50-64 years, interaction: p ≤ 0.001). CONCLUSION: Living with one or more chronic conditions is associated with poorer psychological well-being. Findings point toward a greater focus on supporting psychological well-being in older adults with both mental and somatic conditions.