Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial.

BACKGROUND: (Neo-)adjuvant chemotherapy for breast cancer is effective but has deleterious side effects on muscle tissue, resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high-intensity training versus low-to-moderate intensity training on muscle tissue cellular outcomes and physical function in patients with breast cancer during chemotherapy. OBJECTIVE: The aim of this substudy within the Physical Training in Cancer (Phys-Can) consortium is to evaluate and compare the effects of high and low-to-moderate intensity exercise on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in women with breast cancer undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if the effects of chemotherapy including taxanes on muscles will be different from those of taxane-free chemotherapy. METHODS: Eighty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to a combination of strength and endurance training, either at high intensity or at low-to-moderate intensity. Testing of muscle function and cardiorespiratory fitness and collection of muscle biopsies from the vastus lateralis muscle will be performed before the first cycle of chemotherapy (or after 1 week, when not possible) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% of the participants will be willing to undergo muscle biopsies. To separate the effect of the treatment itself, a usual care group with no supervised training will also be included, and in this group, testing and collection of muscle biopsies will be performed at T0 and T2 only. RESULTS: This study is funded by Active Against Cancer (Aktiv mot kreft) (May 2013) and the Norwegian Cancer Society (December 2018). Inclusion started in December 2016 and the last participant is expected to be recruited in December 2022. As of June 2022, we enrolled 38 (19 with biopsies) participants to the high-intensity training group, 36 (19 with biopsies) participants to the low-to-moderate intensity training group, and 17 (16 with biopsies) participants to the usual care group. Data analyses will start in fall 2022. The first results are expected to be published in spring 2024. CONCLUSIONS: This study will generate new knowledge about the effects of different training intensities for women with breast cancer during chemotherapy treatment. It will give further insight into how chemotherapy affects the muscle tissue and how physical training at different intensities may counteract the treatment side effects in muscles. The results of this study will inform the development and refinement of exercise programs that are effective and compatible with the multidisciplinary management of breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT05218876; https://tinyurl.com/ysaj9dhm. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40811.

Determinants of exercise adherence and maintenance for cancer survivors: Implementation of a community-based group exercise program. A qualitative feasibility study.

Objective: Despite verified knowledge that physical exercise plays an important part in recovery after cancer treatment, multiple studies have shown that maintaining a physically active lifestyle after cancer is challenging. There is a need for qualitative studies to increase understanding into patient experiences and perspectives, and facilitate the design of more sustainable exercise program. This qualitative descriptive feasibility study explores experiences from the implementation of a novel four-month community-based group exercise program for cancer survivors within municipality health service after completion of rehabilitation in the specialist health care service. Methods: Fourteen cancer survivors participated in focus group interviews after completing Rehabilitation: Physical activity and Coping - feasibility study. Data were analyzed using the systematic text condensation method. Results: We identified a main category, Determinants for exercise adherence and maintenance and four subcategories: peer-support, environment, structure and knowledge. Conclusion: A social and supportive exercise environment promotes exercise adherence and maintenance among cancer survivors. This knowledge can be useful for further efforts to implement high quality community-based group exercise programs for cancer survivors. Innovation: This study adds knowledge of survivors' experience of a novel community-based group exercise program in clinical practice and can promote the implementation of sustainable community-based exercise programs for cancer survivors.

Moderate-to-vigorous intensity physical activity is associated with modified fatigue during and after cancer treatment.

PURPOSE: The primary objective was to investigate the association between the amount of time spent in moderate-to-vigorous intensity physical activity (MVPA) and cancer-related fatigue (CRF) before, during, and 2 years after start of treatment. METHODS: The results of the present study are based on data from the study "Early rehabilitation of cancer patients." Two hundred and forty patients (109 females) with one of the following cancer types were included: breast, colorectal, prostate and testicular cancer, and lymphoma. Chalder's fatigue questionnaire (FQ) was used to map CRF at baseline, 4, 8, 12, and 24 months post-inclusion. Baseline was at the time of diagnosis, before treatment start. Physical activity was recorded using SenseWear armband (SWA) at baseline, 4 and 24 months post-inclusion. RESULTS: One hour increased MVPA daily at baseline was associated with lower fatigue with - 0.8 at 4 months' follow-up (p < 0.001), - 0.7 at 8 months' follow-up (p = 0.001), - 0.6 at 12 months' follow-up (p = 0.008), and - 0.5 at 24 months' follow-up (p < 0.043). The participants maintained and improved PA level at the two follow-up points. CONCLUSION: The results imply that the amount of time spent in moderate to vigorous intensity physical activity at baseline can modify cancer related fatigue during and after cancer treatment. The participants managed to maintain and improve their activity level at the two follow-up points. Future research should map fatigue and measure activity, with objective measurement units, at several measurement points to map activity level over time and to substantiate these results.

Early rehabilitation of cancer patients-An individual randomized stepped-care stress-management intervention.

OBJECTIVE: To evaluate the effects of an individual stepped-care stress-management intervention for cancer patients on cancer-related stress reactions (intrusion/avoidance), and secondarily on psychological distress (anxiety/depression) and emotional reactivity (impatience/hostility). METHODS: Consecutively 291 cancer patients were included in a randomized controlled intervention study. Patients randomized to the intervention who did not report clinically significant stress levels (n = 72) after the first counseling session participated in only one counseling session and a follow-up (Step 1). The remaining patients (n = 66) received an additional three to eight sessions, depending on individual needs (Step 2). The intervention used techniques derived from cognitive behavioral therapy (CBT) such as daily registration of events and behaviors as well as scheduled behavioral and physical activity, along with short relaxation exercises. The intervention was completed within 26 weeks of inclusion. The Impact of Event Scale, Hospital Anxiety and Depression Scale, and Everyday Life Stress Scale were used to evaluate effects for 2 years. RESULTS: The linear mixed effects model analysis showed a difference between the randomization groups in favor of the intervention for avoidance and intrusion after the first 6 weeks (P = 0.001 and P = 0.003) and for emotional reactivity after 17 weeks (P = 0.007). There were no differences in psychological distress. Decreases in cancer-related stress reactions and depression were noted for the Step 2 intervention. CONCLUSIONS: An individual stepped-care stress-management intervention for cancer patients, performed by specially educated health professionals using techniques derived from CBT, seems beneficial for cancer patients and may therefore be a realistic complement to routine cancer care.

Early rehabilitation of cancer patients - a randomized controlled intervention study.

BACKGROUND: Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. METHOD: Patients (≥ 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. DISCUSSION: This RCT will provide empirical evidence of whether an individually administered stress-management programme in two steps can decrease stress as well as maintain or enhance patients' physical activity level, quality of life and psychological well-being. Further, this RCT, with a stepped-care approach, will provide knowledge regarding the cost-effectiveness of an individually administered stress-management programme whose aim is to help and support individual patients at the right level of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT 01588262.