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. 2024 Dec 30.
doi: 10.1007/s11764-024-01737-6. Online ahead of print.

Complex intervention including pain science education and patient-led goal setting-based self-management strategies for management of aromatase inhibitor-induced musculoskeletal symptoms: a single-arm feasibility and pilot study

Masahiro Manfuku  1   2 , Tomohiko Nishigami  3 , Akira Mibu  4 , Hirofumi Yamashita  2   5 , Shuhei Ishida  2   6 , Ryota Imai  7 , Astrid Lahousse  8   9 , Hiroe Kanamori  10 , Kazuhiro Sumiyoshi  10
Affiliations

Complex intervention including pain science education and patient-led goal setting-based self-management strategies for management of aromatase inhibitor-induced musculoskeletal symptoms: a single-arm feasibility and pilot study

Masahiro Manfuku et al. J Cancer Surviv. .

Abstract

Purpose: Up to 74% of breast cancer survivors (BCS) treated with aromatase inhibitor (AI) experience AI-induced musculoskeletal symptoms (AIMSS). AIMSS is the predominant cause of poor adherence to AI therapy, yet no definitive treatment exists. The primary research objectives of this study were (1) to develop a novel BCS-specific complex intervention to alleviate AIMSS, and to assess its feasibility. The secondary research objective was (2) to assess the preliminary efficacy of this intervention.

Methods: A single-arm, longitudinal pilot study was conducted involving 15 BCS with AIMSS. The complex intervention, which included pain science education, patient-led goal setting, and self-management strategies, was administered over 3 months. Feasibility was assessed by measuring overall participation, treatment completion rates, and satisfaction after 3 months of intervention. Additionally, the preliminary efficacy of the intervention was evaluated using a mixed model repeated measures analysis, with the change in pain intensity (brief pain inventory [BPI] worst pain/stiffness intensity) at 3 months as the primary endpoint.

Results: The feasibility assessment showed promising results, with a 70.7% participation rate, an 83.3% intervention completion rate, and a satisfaction score of 8.2 ± 1.5. The intervention significantly reduced BPI worst pain/stiffness intensity by 2.78 points after 3 months (95% CI, - 4.5 to - 0.87, p < 0.01). Secondary outcomes demonstrated significant improvements in disability, quality of life, and pain catastrophizing (p < 0.05).

Conclusion: The novel complex intervention appears valuable for management AIMSS in BCS. Future large-scale studies, including randomized controlled trials, are warranted.

Trial registration: The study was registered in the Clinical Trials Registry of the University Hospital Medical Information Network (UMIN-CTR: UMIN 000049035) in October 2022.

Implications for cancer survivors: The novel BCS-specific complex intervention program holds the potential to aid in managing AIMSS, improving adherence to AI therapy, and enhancing their quality of life.

Keywords: Aromatase inhibitor; Aromatase inhibitor–induced musculoskeletal symptoms; Breast cancer; Cancer pain; Pain science education; Patient-led goal setting.

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Conflict of interest statement

Declarations. Ethical approval and consent to publish: The study was approved by the Ethics Committee of Prefectural Hiroshima University (No. 22MH018) and registered in the Clinical Trials Registry of the University Hospital Medical Information Network (UMIN-CTR: UMIN 000049035) ( https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055679 ). All participants provided written informed consent to participate in the study, and consented to the presentation or publishing of anonymized data. The study was reported in accordance with the SPIRIT statement. Competing interests: The authors declare no competing interests.

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