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| The effect of a single session of 30-min mindful breathing in reducing fatigue among patients with haematological cancer -- a randomised controlled trial |
| Ng D-L-C, Gan G-G, Anuar NA, Tung Y-Z, Lai N-Z, Tan Y-W, Said SNM, Madihie A, Chai C-S, Tan S-B |
| BMC Palliative Care 2021 Oct 15;20(160):Epub |
| 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: Yes; Intention-to-treat analysis: No; 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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BACKGROUND: Patients with haematological cancer had considerable symptom burden, in which fatigue was the most prevalent. Almost 70% of haematological cancer patients reported fatigue. METHODS: We conducted a parallel-group, non-blinded, randomised control trial at the haemato-oncology unit of University Malaya Medical Centre, from 1st October 2019 to 31st May 2020. Patients included were >= 18 years, had histopathological diagnosis of haematological cancer, and fatigue score of >= 4 based on the fatigue subscale of Edmonton Symptom Assessment System (ESAS). Patients allocated to the intervention group received standard care plus a guided 30-min mindful breathing session, while those in control group received standard care. The study outcomes include fatigue severity according to the fatigue subscale of ESAS, visual analogue scale of 0 to 10, and Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4, at minute 0 and minute 30. RESULTS: Of 197 patients screened, 80 were eligible and they were equally randomised into 30-min mindful breathing versus standard care. Lymphoma (58.9%) was the commonest haematological malignancy, followed by multiple myeloma (13.8%), acute leukaemia (11.3%), myeloproliferative neoplasm (6.3%), chronic leukaemia (5.0%) and myelodysplastic syndrome (5.0%). There was no difference in the demographic and clinical characteristics between the 2 groups. At minute 0, both arms of patients had similar ESAS-fatigue score (median, 5) and FACIT-fatigue score (mean +/- SD, 24.7 +/- 10.6 for intervention group versus 24.7 +/- 9.7 for control group). At minute 30, intervention group had lower ESAS-fatigue score (median 3 versus 5) and FACIT-fatigue score (mean +/- SD, 17.1 +/- 10.5 versus 24.8 +/- 11.3) compared to control group. Both the ESAS-fatigue score reduction (median -2 versus 0, p = 0.002) and FACIT-fatigue score reduction (mean +/- SD, -6.7 versus +0.8; p < 0.001) for the intervention group were statistically significant. The calculated effect size Cohen's d was 1.4 for between-group comparison of differences in total FACIT-fatigue score. CONCLUSIONS: Our results provide evidence that a single session of 30-min mindful breathing was effective in reducing fatigue in haematological cancer patients. On top of all the currently available methods, 30-min mindful breathing can prove a valuable addition. TRIAL REGISTRATION: NCT05029024, date of registration 15th August 2021 (retrospectively registered).
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