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Pilot randomized controlled trial of a program to enhance experience and adherence with adjuvant endocrine therapy among women with non-metastatic breast cancer: 12-month quantitative results

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Abstract

Purpose

Adjuvant endocrine therapy (AET) reduces recurrence risk after hormone receptor-positive breast cancer, but non-adherence is common. We pilot-tested SOIE, a program to enhance AET experience and adherence, to assess its acceptability, feasibility, and effects on psychosocial precursors of AET adherence.

Methods

We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention – primary outcome -, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations.

Results

A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01).

Conclusion

SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake.

Implications for Cancer Survivors

SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.

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Data availability

 The datasets generated and / or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

We thank all the women who participated in the study, the healthcare team members (Drs. André Blais, Dominique Boudreau, Chantale Brien, Guy Cantin, Jocelyne Chiquette, Christine Desbiens, Catherine Doyle, Maryse Joyal, Dominique Leblanc, Julie Lemieux, Brigitte Poirier, Éric Poirier, Louise Provencher, Lucie Vaillancourt), and Jean-Charles Hogues at the Breast Disease Center at the CHU de Québec-Université Laval who participated in the recruitment, the professionals who dispensed the program’s components (Martine Carignan, Isabelle Côté, Sébastien Faucher, Liette Martel, Valérie Otis, Sophie Ruelland, and Sara Vaillancourt) and Éric Demers who participated in the statistical analyses. We also thank Sue-Ling Chang, who reviewed the manuscript for English. Finally, we thank the research team from reMed, a data registry for prescribed medications (http://projetremed.ca/), for their support in collecting pharmacy claims data, and the Souza Institute (cancerchat.desouzainstitute.com) for providing access to the Cancer chat platform.

Funding

The work was supported by the Canadian Institutes of Health Research (CIHR) (grant #367503) and the Fondation du CHU de Québec-Université Laval (grants #3167; #4024). Odilon Assan received a Master’s scholarship from Sophie Lauzier and from the Fonds d’enseignement et de recherche, Faculty of Pharmacy, Université Laval. Victoria Memoli received a Ph.D. scholarship from the Excellence Initiative of Aix-Marseille University—A*Midex, a French “Investissements d’Avenir programme” AMX-20-IET-014. She was supported by a grant from the Aix-Marseille Institute of Public Health Sciences (#ISSPAM-21-FLASH-00x), a mobility grant from the EHESP and the PACA canceropole. Sophie Lauzier is a research scholar with funding from the Fonds de recherche du Québec–Santé (Québec Health Research Fund) in partnership with the Unité Soutien SRAP du Québec (#313085). Martine Lemay received a research grant Bourse de formation Desjardins pour la recherche et l’innovation de la Fondation du CHU de Québec-Université Laval.

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Authors and Affiliations

  1. Faculty of Pharmacy, Université Laval, 1050 Avenue de la Médecine, Quebec, QC, G1V 0A6, Canada

    Odilon Assan, Anne Dionne, Line Guénette & Sophie Lauzier

  2. Aix-Marseille University, INSERM, IRD, SESSTIM, ISSPAM, Cancer, Biomedicine & Society Group, Équipe Labellisée Ligue Contre Le Cancer, 27 bd Jean Moulin, 13385, Marseille, France

    Victoria Memoli

  3. CHU de Québec-Université Laval Research Center, Population Health and Optimal Health Practices Axis, 1050 Chemin Ste-Foy, Quebec, QC, G1S 4L8, Canada

    Laurence Guillaumie, Véronique Turcotte, Line Guénette & Sophie Lauzier

  4. Faculty of Nursing, Pavillon Ferdinand-Vandry, Université Laval, 1050 Avenue de la Médecine, Quebec, QC, G1V 0A6, Canada

    Laurence Guillaumie

  5. Centre des Maladies du Sein (Breast Disease Center), CHU de Québec-Université Laval, Hôpital du Saint-Sacrement, 1050 Chemin Ste-Foy, Quebec, QC, G1S 4L8, Canada

    Martine Lemay, Anne Dionne, Julie Lemieux & Louise Provencher

  6. CHU de Québec-Université Laval Research Center, Oncology Axis, 1050 Chemin Ste-Foy, Quebec, QC, G1S 4L8, Canada

    Anne Dionne, Julie Lemieux & Louise Provencher

  7. School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada

    Carolyn Gotay

  8. Radboud Institute for Health Sciences, IQ Healthcare, Nijmegen, the Netherlands

    Marijn de Bruin

  9. Équipe de Recherche Michel-Sarrazin en Oncologie Psychosociale et Soins Palliatifs (ERMOS), 2101 Chemin Saint-Louis, Quebec, QC, G1T 1P5, Canada

    Sophie Lauzier

  10. Cancer Research Center, Pavillon Ferdinand-Vandry, Université Laval, 1050 Avenue de la Médecine, Quebec, QC, G1V 0A6, Canada

    Sophie Lauzier

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  1. Odilon Assan
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Contributions

All authors contributed to the study’s conception and design. Material preparation and data collection were supervised by Véronique Turcotte and Sophie Lauzier. The program was delivered by Anne Dionne and Martine Lemay, and analyses were performed by Odilon Assan, Victoria Memoli, and Sophie Lauzier. Odilon Assan, Victoria Memoli, and Sophie Lauzier wrote the first draft of the manuscript, and all authors commented on previous versions. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Sophie Lauzier.

Ethics declarations

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Research Ethics Board of the CHU de Québec-Université Laval (MP-20–2018-4131).

Consent to participate

Informed written consent was obtained from all individual participants included in the study.

Competing interests

Sophie Lauzier has received unrestricted research grants from Pfizer Canada and Eli Lilly for other studies not related to the one presented in this manuscript. Julie Lemieux has received honoraria from Novartis, Eli Lilly, Gilead, and Astra Zeneca not related to the one presented in this manuscript. All the other authors have no relevant financial or non-financial interests to disclose.

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Odilon Assan and Victoria Memoli are the joint first authors.

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Assan, O., Memoli, V., Guillaumie, L. et al. Pilot randomized controlled trial of a program to enhance experience and adherence with adjuvant endocrine therapy among women with non-metastatic breast cancer: 12-month quantitative results. J Cancer Surviv (2024). https://doi.org/10.1007/s11764-024-01599-y

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