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| Feasibility and possible effects of mindful walking and moderate walking in breast cancer survivors: a randomized controlled pilot study with a nested qualitative study part |
| Schroder ML, Stockigt B, Binting S, Tissen-Diabate T, Bangemann N, Goerling U, Kroz M, Blohmer J-U, Ortiz M, Brinkhaus B |
| Integrative Cancer Therapies 2022 Jan-Dec;21:15347354211066067 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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INTRODUCTION: Breast cancer (BC) survivors often suffer from disease- and therapy-related long-term side-effects. The study aim was to explore the feasibility, adherence, and individual experiences as well as possible effects of 2 different walking interventions in BC patients. METHODS: This randomized controlled, pragmatic pilot trial included a qualitative study component. BC patients were randomized to either mindful walking (MFW) with mindfulness exercises and walking or moderate walking (MW) alone in weekly group sessions over 8 weeks. After 8 and 16 weeks, satisfaction, and self-perceived effectiveness as well as different health-related outcomes including health-related (WHOQOL-BREF) and disease-specific quality of life (FACT-G), perceived stress (PSQ) and cancer-related fatigue (CFS-D) were assessed. ANCOVA was used to evaluate differences in study outcomes. Qualitative data included 4 focus group interviews including 20 patients and were analyzed using a directed qualitative content analysis approach. RESULTS: Altogether, 51 women (mean age 55.8 years (SD 10.9)) were randomized (n = 24 MFW; n = 27 MW). Both groups would recommend the course to other BC patients (MFW 88.9%; MW 95.2%) and showed possible improvements from baseline to week 8, without statistically significant difference between groups: WHOQOL-BREF (MFW: adjusted mean 65.4 (95% confidence interval (CI) 57.1 to 73.7); MW: 61.6 (53.6 to 69.6)); FACT-G (MFW: 76.0 (71.5 to 80.5); MW: 73.0 (68.5 to 77.4)); PSQ (MFW: 45.3 (40.5 to 50.1); MW: 45.4 (40.8 to 50.0)); CFS-D (MFW: 24.3 (20.8 to 27.8); MW: 25.5 (22.1 to 28.8)). Improvements lasted until the 16-weeks follow-up. The qualitative analysis suggested that MFW primarily promoted mindfulness, self-care, and acceptability in BC patients, whereas MW activated and empowered the patients as a result of the physical exercise. CONCLUSION: Both study interventions were positively evaluated by patients and showed possible pre-post effects in disease-specific health-related outcomes without differences between groups. The qualitative analysis results indicate that different resources and coping strategies were addressed by the 2 study interventions. TRIAL REGISTRATION: DKRS00011521; prospectively registered 21.12.2016; https://www.drks.de/drksweb/navigate.do?navigationId=trial.HTML&TRIALID=DRKS00011521.
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