Strategies to self-manage side-effects of adjuvant endocrine therapy among breast cancer survivors: an umbrella review of empirical evidence and clinical guidelines

Hall, Louise; King, Natalie; Graham, Christopher D.; Green, Sophie M. C.; Barber, Alice; Neal, Richard D; Foy, Robbie; Clark, Jane E.; Lloyd, Kelly; Smith, Samuel G.

doi:10.1007/s11764-021-01114-7

Cited by 7 publications

(5 citation statements)

References 75 publications

(382 reference statements)

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“…Few interventions designed to deliver oral anti-cancer medication support have been tested to date, and those that exist have had limited success [ 23 , 24 , 25 , 26 ] or are in the early stages of development [ 23 , 27 , 28 , 29 ]. Some evidence suggests that mindfulness-based stress reduction and relaxation training can promote long-term adherence to ET [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

Wheeler

Spencer²,

Drier

et al. 2023

Cancers

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Background: Oral endocrine therapy (ET) is an inexpensive and effective therapy for hormone receptor-positive (HR+) breast cancer that prevents recurrence but relies upon long-term adherence for up to ten years. More than 80% of breast cancer patients have an HR+ phenotype and are candidates for ET, but approximately half discontinue or become non-adherent by five years. ET underuse is more prevalent in Black and young (<50 yrs) women, which may contribute to outcome disparities in these groups. The objective of this study was to evaluate the feasibility, acceptability, and utility of a patient-centered counseling intervention to enhance ET adherence, with a focus on the needs of Black and younger women. Methods: We conducted a single-arm pilot study of a twelve-month motivational interviewing (MI) intervention consisting of five MI counseling sessions, an interactive workbook, a resource guide, and an educational video developed and revised with iterative patient and clinician input. The eligible participants were >18 years old, English speaking, and with stage I–III HR+ breast cancer. Participants were recruited across a large academic medical center and four community sites. Feasibility and acceptability were assessed by measures of participant recruitment, retention, session participation, and patient-reported satisfaction. ET adherence at 12 months was assessed by self-report and medication event monitoring system (MEMS) caps using a continuous measure of the proportion of days covered (PDC) as well as a dichotomous measure of the optimal adherence, defined as >80% PDC. Results: Forty-two women initiated the intervention, of whom thirty-five participants (83%) completed outcome assessments at 12 months, including thirteen Black and twenty-two non-Black participants. The average participant age was 54.8 years (range: 25–73). Overall, 97% completed at least three MI sessions and 83% completed at least four sessions. Participant retention and satisfaction were high, particularly among Black women. Self-reported adherence at 12 months was 88% overall (100% in Black women and 81% in non-Black women). The majority of women also achieved 80% of days adherent using MEMS caps, with a greater adherence in Black women. Conclusions: This study demonstrates the feasibility, acceptability, and early promise of the effectiveness of an MI counseling-based intervention to promote ET adherence and prevent breast cancer recurrence in diverse populations.

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Section: Discussionmentioning

confidence: 99%

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

Wheeler

Spencer²,

Drier

et al. 2023

Cancers

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“…The ACTION intervention website included advice about AET medication side‐effects, derived from an umbrella review of AET side‐effect management reviews and guidelines, 22 and supplementary ACT exercises. Videos of patient stories related to their breast cancer and treatment experiences were embedded within the website.…”

Section: Methodsmentioning

confidence: 99%

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision‐making and quality of life in women with breast cancer: The ACTION trial

Graham,

Ellison,

Hall

et al. 2024

Psycho-Oncology

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ObjectiveNon‐adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side‐effects and distress. We co‐designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision‐making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability.MethodsThis was a multi‐site, exploratory, two‐arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one‐to‐one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self‐management of side effects.ResultsOf the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3‐month and 70 (88.6%) at 6‐month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire‐12), QoL (work and social adjustment scale), health‐related QoL (functional assessment of cancer therapy[FACT] general and FACT‐ES‐19/23), distress (generalised anxiety disorder ‐7, patient health questionnaire‐9) and psychological flexibility (valuing questionnaire).ConclusionsThe ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible.Trial RegistrationISRCTN12027752.

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“…Women feel unsupported in managing side-effects,27 57 78 and would like clearer information on self-management strategies 58 79. We undertook an umbrella review of systematic reviews and clinical guidelines on self-management strategies for common AET side-effects 80. This review informed the creation of a patient-facing website to support side-effect management in women using AET.…”

Section: Methods and Analysismentioning

confidence: 99%

Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial

et al. 2023

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IntroductionWomen with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component.Methods and analysisThe four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 24-1fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data.Ethics and disseminationThe study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal.Trial registration numberISRTCN10487576.

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Strategies to self-manage side-effects of adjuvant endocrine therapy among breast cancer survivors: an umbrella review of empirical evidence and clinical guidelines

Cited by 7 publications

References 75 publications

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

Motivational Interviewing Counseling to Increase Endocrine Therapy Adherence in Diverse Patients

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision‐making and quality of life in women with breast cancer: The ACTION trial

Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial

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