A randomised wait-list controlled trial to evaluate Emotional Freedom Techniques for self-reported cancer-related cognitive impairment in cancer survivors (EMOTICON)

Laura Tack, Tessa Lefebvre, Michelle Lycke, Chistine Langenaeken, Christel Fontaine, Marleen Borms, Marianne Hanssens, Christel Knops, Kathleen Meryck, Tom Boterberg, Hans Pottel, Patricia Schofield, Philip R Debruyne, Laura Tack, Tessa Lefebvre, Michelle Lycke, Chistine Langenaeken, Christel Fontaine, Marleen Borms, Marianne Hanssens, Christel Knops, Kathleen Meryck, Tom Boterberg, Hans Pottel, Patricia Schofield, Philip R Debruyne

Abstract

Background: Cancer-related cognitive impairment (CRCI) is a prevalent source of comprised quality of life in cancer survivors. This study evaluated the efficacy of Emotional Freedom Techniques (EFT) on self-reported CRCI (sr-CRCI).

Methods: In this prospective multicentre randomised wait-list controlled study (ClinicalTrials.gov Identifier: NCT02771028), eligible cancer survivors had completed curative treatment, were 18 years or older and screened positive for sr-CRCI with ≥ 43 on the Cognitive Failures Questionnaire (CFQ). Participants were randomised to the immediate treatment group (ITG) or wait-list control (WLC) group, based on age (< or ≥ 65 years), gender, treatment (chemotherapy or not), and centre. The ITG started to apply EFT after inclusion and performed this for 16 weeks. The WLC group could only start the application of EFT after 8 weeks of waiting. Evaluations took place at baseline (T0), 8 weeks (T1) and 16 weeks (T2). The primary outcome was the proportion of patients with sr-CRCI according to the CFQ score.

Findings: Between October 2016 and March 2020, 121 patients were recruited with CFQ ≥ 43 indicating sr-CRCI. At T1, the number of patients scoring positive on the CFQ was significantly reduced in the ITG compared to the WLC group (40.8% vs. 87.3% respectively; p<0.01). For the WLC group, a reduction in CFQ scores was observed at T2, comparable to the effect of the ITG at T1. Linear mixed model analyses indicated a statistically significant reduction in the CFQ score, distress, depressive symptoms, fatigue and also an improvement in quality of life.

Interpretation: This study provides evidence for the application of EFT for sr-CRCI in cancer survivors and suggests that EFT may be useful for other symptoms in cancer survivors.

Keywords: Cancer survivorship; Cancer-related cognitive impairment; Emotional freedom techniques; Subjective cognitive complaints.

Conflict of interest statement

All authors have no conflicts of interest to declare, except for co-author dr. Christel Fontaine who received financial support for attending online ESMO 2020, ICOS 2020, SABCS 2020, EBCC 2021, ASCO 2021, MASCC 2021, ECHNO 2021.

© 2021 The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT diagram.
Fig. 2
Fig. 2
Head, torso and hand acupressure points involved in the application of EFT (Figure adapted from Church et al. [27]). The process starts with a ‘Setup Statement’ while performing acupoint tapping on the side of the hand. For the remainder of the process, patients gently tap with two fingers on head and torso points while repeating the ‘Reminder Phrase’.
Fig. 3
Fig. 3
CFQ scores over time for the immediate treatment group (ITG) and wait-list control (WLC) group, based on results of the linear mixed model analyses. CFQ scores may vary between 0 and 100, with ≥43 indicating CRCI. In the ITG, there is an estimated mean difference of 18.5 points at T1 (95% CI: −21.73, −15.28; p<0.001) which continued at T2 (−3.85; 95% CI: −7.32, −0.38; p<0.05). For the WLC group, there was already a significant reduction in sr-CRCI at T1 (−4.35; 95% CI: −7.42, −1.28; p<0.01) which continued at T2 (−12.86; 95% CI: −16.11, −9.62; p<0.001). Legend: blue = immediate treatment group; red = wait-list control group. Error bars present 95% confidence interval for estimated marginal mean (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.).
Fig. 4
Fig. 4
Estimated marginal mean scores over time for secondary PROMs: (A) DT (scores ranging from 0 to 10; high score indicates more distress); (B) 38-item PL (39 items, scores ranging from 0 to 38; high score indicates more distress); (C) BDI-II (21 items, scores are classified as minimal (0–13), mild (14-19), moderate (20-28), and severe (29-63)); (D) FACIT-Fatigue (13 items, scores ranging from 0 to 52; high score indicates less fatigue), separately for both treatment arms in the total study population, based on results of the linear mixed model analyses. Results of the linear mixed model analyses indicated that the DT, 38-item PL, BDI-II and FACIT-fatigue scale significantly improved from T0 to T1 in the immediate treatment group (ITG) (p<0.001). This did not continue at T2 (p>0.05). In the wait-list control (WLC) group, the 38-item PL was already statistically significant improved from T0 to T1 (p<0.01) which continued at T2 (p<0.001). The DT, BDI-II and FACIT-fatigue scale only improved as from T1 in the WLC group (p<0.001). Legend: blue = immediate treatment group; red = wait-list control group. Error bars present 95% confidence interval for estimated marginal mean. Abbreviations: PROMs: patient-reported outcome measures; DT: distress thermometer; PL: 38-item problem list (PL); BDI-II: Beck Depression Inventory-II; FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.).
Fig. 5
Fig. 5
Estimated marginal mean scores over time for HRQoL measures, derived from the EORTC QLQ-C30: (A) Summary Score; (B) Global Health Status; (C) Emotional functioning; (D) Cognitive functioning; (E) Social functioning; (F) Fatigue, separately for both treatment arms in the total study population, based on results of the linear mixed model analyses. All of the scales range in score from 0 to 100. Results of the linear mixed model analyses indicated that the Summary Score, Global Health Status, Emotional functioning, Cognitive functioning, Social functioning and Fatigue significantly improved from T0 to T1 in the immediate treatment group (ITG) (p<0.001). This did not continue at T2 (p>0.05). For the wait-list control (WLC) group, there was no significant improvement observed at T1 (p>0.05). Improvement in the WLC for Summary Score (p<0.001), Global Health Status (p<0.001), Emotional functioning (p<0.001) Cognitive functioning (p<0.001), Social functioning (p<0.05) and Fatigue (p = 0.001) was observed at T2. Legend: blue = immediate treatment group; red = wait-list control group. Error bars present 95% confidence interval for estimated marginal mean. Abbreviations: HRQoL: health-related quality of life; EORTC QLQ-C30: European Organization for Research and Treatment for Cancer QoL Questionnaire (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.).
Fig. 6
Fig. 6
EuroQoL EQ-5D-3L: Estimated marginal mean scores over time for the immediate treatment group (ITG) and wait-list control (WLC) group, based on results of the linear mixed model analyses. These analyses indicated that the EuroQol EQ-5D-3 L scores significantly improved at all time points when compared to baseline result at T0 in the ITG (p<0.005). In the WLC group, this significant improvement was observed as from T1 and was maintained until 12 months of follow-up when compared to baseline result at T0 (p<0.005). Legend: blue = immediate treatment group; red = wait-list control group. Error bars present 95% confidence interval for estimated marginal mean. Abbreviations: EuroQol EQ-5D-3L: instrument including 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with 3 levels of severity (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.).

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