Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

Joanna J Arch^{1

2}, Catherine M Crespi³, Michael E Levin⁴, Sarah R Genung¹, Madeline Nealis¹, Jill L Mitchell⁵, Emma E Bright¹, Karen Albright⁶, Jessica F Magidson⁷, Annette L Stanton^{8

9

10

11}

Affiliations

¹ Department of Psychology and Neuroscience, University of Colorado Boulder, 345 UCB Muenzinger, Boulder, CO, 80309-0345, USA.
² Division of Cancer Prevention and Control, University of Colorado Cancer Center, Aurora, CO, USA.
³ Fielding School of Public Health, Department of Biostatistics, University of California Los Angeles, Los Angeles, CA, USA.
⁴ Department of Psychology, Utah State University, Logan, UT, USA.
⁵ Rocky Mountain Cancer Centers-Boulder, Boulder, CO, USA.
⁶ Department of Medicine, Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
⁷ Department of Psychology, University of Maryland, College Park, MD, USA.
⁸ Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.
⁹ Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.
¹⁰ Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.
¹¹ Semel Institute for Neuroscience, Cousins Center for Psychoneuroimmunology, University of California Los Angeles, Los Angeles, CA, USA.

PMID: 35323853
PMCID: PMC9345183
DOI: 10.1093/abm/kaab118

Randomized Controlled Trial

Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

Joanna J Arch et al. Ann Behav Med. 2022.

. 2022 Aug 2;56(8):856-871.

doi: 10.1093/abm/kaab118.

Authors

Affiliations

¹ Department of Psychology and Neuroscience, University of Colorado Boulder, 345 UCB Muenzinger, Boulder, CO, 80309-0345, USA.
² Division of Cancer Prevention and Control, University of Colorado Cancer Center, Aurora, CO, USA.
³ Fielding School of Public Health, Department of Biostatistics, University of California Los Angeles, Los Angeles, CA, USA.
⁴ Department of Psychology, Utah State University, Logan, UT, USA.
⁵ Rocky Mountain Cancer Centers-Boulder, Boulder, CO, USA.
⁶ Department of Medicine, Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
⁷ Department of Psychology, University of Maryland, College Park, MD, USA.
⁸ Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.
⁹ Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.
¹⁰ Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.
¹¹ Semel Institute for Neuroscience, Cousins Center for Psychoneuroimmunology, University of California Los Angeles, Los Angeles, CA, USA.

PMID: 35323853
PMCID: PMC9345183
DOI: 10.1093/abm/kaab118

Abstract

Background: Oral anti-cancer treatments such as adjuvant endocrine therapies (AET) for breast cancer survivors are commonly used but adherence is a challenge. Few low-touch, scalable interventions exist to increase ET adherence.

Purpose: To evaluate the acceptability, feasibility, and initial efficacy of a low-touch, remotely-delivered values plus AET education intervention (REACH) to promote AET adherence.

Methods: A mixed-methods trial randomized 88 breast cancer survivors 1:1 to REACH or Education alone. Wisepill real-time electronic adherence monitoring tracked monthly AET adherence during a 1-month baseline through 6-month follow-up (FU) (primary outcome). Patient-reported outcomes were evaluated through 3- and 6-month FU (secondary). Multiple indices of intervention feasibility and acceptability were evaluated. Qualitative exit interviews (n = 38) further assessed participants' perceptions of feasibility/acceptability and recommendations for intervention adaptation.

Results: The trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention sessions, and "good" intervention satisfaction ratings on average. For Wisepill-assessed AET adherence, REACH outperformed Education for Month 1 of FU (p = .027) and not thereafter. Participants in REACH maintained high adherence until Month 4 of FU, whereas in Education, adherence declined significantly in Month 1. Conditions did not differ in self-reported adherence, positive affective attitudes, future intentions, or necessity beliefs. REACH trended toward less negative AET attitudes than Education at 3-month FU (p = .057) reflecting improvement in REACH (p = .004) but not Education (p = .809). Exploratory moderator analyses showed that average to highly positive baseline AET affective attitudes and oncologist-patient communication each predicted higher adherence following REACH than Education; low levels did not. Participants identified recommendations to strengthen the interventions.

Conclusions: REACH, a low-touch values intervention, showed good feasibility and acceptability, and initial promise in improving objectively-assessed AET adherence among breast cancer survivors (relative to education alone). Future research should target improving REACH's tailoring and endurance.

Keywords: Acceptance and commitment therapy; Adherence; Breast cancer; Endocrine therapy; Real-time adherence monitoring; Values.

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Figures

**Fig. 2.**
Condition differences in Wisepill-assessed AET adherence at FU month 1 for different levels of the moderators (REACH minus education).

See this image and copyright information in PMC

References

1. World Cancer Research Fund/American Institute for Cancer Research: Diet, Nutrition, Physical Activity and Breast Cancer. 2018, from dietandcancerreport.org
1. Dunnwald LK, Rossing MA, Li CI. Hormone receptor status, tumor characteristics, and prognosis: A prospective cohort of breast cancer patients. Breast Cancer Res. 2007;9:R6. - PMC - PubMed
1. Hershman DL, Shao T, Kushi LH, et al. . Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011;126:529–537. - PMC - PubMed
1. Early Breast Cancer Trialists’ Collaborative Group: Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet. 2005;365:1687–1717. - PubMed
1. Burstein HJ, Temin S, Anderson H, et al. . Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline focused update. J Clin Oncol. 2014;32:2255–2269. - PMC - PubMed

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Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

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Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors

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