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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

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Journal of Cancer Survivorship Aims and scope Submit manuscript

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.

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Data availability

No datasets were generated or analysed during the current study.

Abbreviations

AI:

Aromatase inhibitor

AIMSS:

Aromatase inhibitor–associated musculoskeletal symptoms

BCS:

Breast cancer survivors

RT:

Radiotherapy

HT:

Hormone therapy

PSE:

Pain science education

BPI:

Brief pain inventory

WOMAC:

Western Ontario and McMaster Universities Osteoarthritis

DASH:

Disabilities of the arm, shoulder, and hand

WPI:

Widespread pain index

EQ-5D-5L:

EuroQol 5-dimensions 5-levels

QST:

Quantitative sensory testing

PPT:

Pressure pain threshold

CPM:

Conditioned pain modulation

CS:

Central sensitization

CSI:

Central sensitization inventory

PCS:

Pain catastrophizing scale

TSK:

Tampa Scale for Kinesiophobia

PSEQ:

Pain self-efficacy questionnaire

CEQ:

Credibility/expectancy questionnaire

GAS:

Goal attainment scaling

GRC:

Global rating of change

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Acknowledgements

The authors are extremely grateful to the breast cancer survivors who participated in and developed this study and to Izumi Kameyama, Yasuko Tanaka, Keiko Dosai, Etsuko Teranishi, Naoko Takahashi, Yoko Sawada, and Miyuki Nakamura for assistance with recruitment.

Funding

This study received funding from Prefectural Hiroshima University.

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Authors and Affiliations

  1. Department of Rehabilitation, Breast Care Sensyu Clinic, Osaka, Japan

    Masahiro Manfuku

  2. Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, Hiroshima, Japan

    Masahiro Manfuku, Hirofumi Yamashita & Shuhei Ishida

  3. Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, Hiroshima, Japan

    Tomohiko Nishigami

  4. Department of Physical Therapy, Konan Women’s University, Hyogo, Japan

    Akira Mibu

  5. Department of Rehabilitation, Nozomi Orthopaedic Clinic Saijo, Hiroshima, Japan

    Hirofumi Yamashita

  6. Department of Rehabilitation, Shimane University Hospital, Shimane, Japan

    Shuhei Ishida

  7. Graduate School of Rehabilitation, Osaka Kawasaki Rehabilitation University, Osaka, Japan

    Ryota Imai

  8. Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium

    Astrid Lahousse

  9. Department of Physical Medicine and Physiotherapy, Chronic Pain Rehabilitation, University Hospital Brussels, Brussels, Belgium

    Astrid Lahousse

  10. Department of Breast Oncology, Breast Care Sensyu Clinic, Osaka, Japan

    Hiroe Kanamori & Kazuhiro Sumiyoshi

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

All authors contributed significantly to the preparation of this manuscript. Concept/idea/research design: M.M, T.N, A.M, H.Y, S.I, R.I, A.L, K.S. Writing: M.M, T.N, A.M, H.Y, S.I, R.I, A.L. Data collection: H.K, K.S. Data analysis: T.N, A.M. Project management: M.M, T.N, A.M. Providing participants: K.S.

Corresponding author

Correspondence to Tomohiko Nishigami.

Ethics 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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Manfuku, M., Nishigami, T., Mibu, A. et al. 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. J Cancer Surviv (2024). https://doi.org/10.1007/s11764-024-01737-6

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  • DOI: https://doi.org/10.1007/s11764-024-01737-6

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