Oncology · Medical Literature
Role of individualized intervention(s) on quality of life and adherence to adjuvant endocrine therapy in premenopausal women with early-stage breast cancer: MyCHOICE study.
Abstract
Premenopausal women receiving combination endocrine therapy often experience substantial declines in quality of life (QOL), cognitive functioning, and treatment adherence. The MyChoice study evaluated whether individualized behavioral and complementary interventions could help maintain or improve QOL and treatment adherence in women with early-stage hormone receptor-positive breast cancer undergoing aromatase inhibitor- or tamoxifen-based therapy with ovarian suppression. In this prospective multicenter phase II study, premenopausal women with newly diagnosed hormone receptor-positive breast cancer were enrolled prior to initiation of combination endocrine therapy. Tailored supportive interventions, including structured exercise programs, restorative yoga, acupuncture, and massage therapy, were offered, and women could choose one or more interventions either alone or in combination. QOL and cognitive function were assessed at baseline, 3 months, and every 6 months for up to 3 years using FACT-B, FACT-ES, and FACT-Cognitive Function instruments. Adherence to endocrine therapy was assessed at each follow-up visit using physician-conducted patient interviews and pharmacy refill records. Longitudinal changes in QOL and their demographic and clinical predictors were analyzed using linear mixed-effects models. Forty premenopausal women participated, with a median age of 43 years. Exercise was the most frequently selected intervention (61%), followed by massage therapy (44%), acupuncture (35%), and yoga (30%). Functional well-being improved significantly over time (1.65 points per year, p = 0.0005). Emotional well-being, social/family well-being, physical well-being, endocrine symptoms, and perceived cognitive abilities remained stable. Adherence to endocrine therapy was high at 92.5% over the follow-up period. In multivariable analyses, younger age (< 35 years) was associated with less favorable outcomes across several domains, including lower FACT-ES scores and lower physical well-being. Individualized, patient-selected supportive interventions may help maintain key aspects of quality of life and support adherence to endocrine therapy in premenopausal women with early-stage breast cancer. These findings support further evaluation in larger, controlled trials.
Clinical relevance
In premenopausal women with early-stage hormone receptor-positive breast cancer initiating combination endocrine therapy (aromatase inhibitor or tamoxifen plus ovarian suppression), do individualized, patient-selected behavioral and complementary interventions maintain or improve quality of life, cognitive function, and treatment adherence compared to baseline over up to three years of follow-up? __SNAPSHOT__ {"studyDesign":"Prospective multicenter single-arm phase II study (no randomized control group)","setting":"Multicenter; academic cancer centers in Saskatchewan, Canada (University of Saskatchewan / Saskatchewan Cancer Agency sites)","sampleSize":"n=40","population":"Premenopausal women with newly diagnosed hormone receptor-positive early-stage breast cancer, enrolled prior to initiation of combination endocrine therapy; median age 43 years. Approximately 75% received (neo)adjuvant chemotherapy, 90% received adjuvant radiation, 95% received an aromatase inhibitor plus ovarian suppression, and 5% received tamoxifen plus ovarian suppression; 90% achieved ovarian suppression via LHRH agonist, 10% via upfront oophorectomy.","intervention":"Patient-selected tailored supportive interventions chosen from: structured exercise programs, restorative yoga, acupuncture, and massage therapy; participants could select one or more modalities. Exercise was selected by 61%, massage therapy by 44%, acupuncture by 35%, and yoga by 30% of participants.","comparator":"Not applicable (single-arm study; outcomes compared to each participant's own baseline)","primaryOutcome":"Change in quality of life and cognitive function over time, assessed using FACT-B, FACT-ES, and FACT-Cognitive Function instruments at baseline, 3 months, and every 6 months for up to 3 years; adherence to endocrine therapy assessed at each follow-up via physician-conducted patient interviews and pharmacy refill records.","followUp":"Up to 3 years (assessments at baseline, 3 months, then every 6 months)","fundingSource":"University of Saskatchewan (non-profit/academic); authors declared no conflicts of interest"}
Key findings
In 40 premenopausal women followed for up to 3 years, functional well-being (FACT-B subscale) improved significantly over time at a rate of 1.65 points per year (p=0.0005; preprint version) — note that a conference abstract version reported 1.42 points/year (p=0.01), indicating some variability across reporting versions; the published journal abstract value of 1.65 pts/yr, p=0.0005 is used as the primary reference. Emotional well-being, social/family well-being, physical well-being, endocrine symptom burden (FACT-ES), and perceived cognitive abilities (FACT-Cognitive Function) remained stable over the observation period — no statistically significant deterioration was observed in these domains. Adherence to combination endocrine therapy was 92.5% across the follow-up period. In multivariable analyses, age younger than 35 years was associated with less favorable outcomes across several domains, including lower FACT-ES scores and lower physical well-being scores. No comparative group was included; therefore, no between-group effect sizes, relative risks, confidence intervals, NNT, or NNH can be calculated or reported. Adverse event data specific to the interventions were not reported in the available abstract.
Practice implications
This single-arm phase II study demonstrates that a patient-choice model of complementary and behavioral supportive care — primarily exercise, massage, acupuncture, and yoga — was associated with stable to modestly improved quality of life domains and high endocrine therapy adherence over 3 years in a small cohort of premenopausal women with HR-positive early-stage breast cancer. What the study establishes: feasibility of a patient-choice supportive care model, stability of most QOL domains over time, and a clinically encouraging adherence rate of 92.5%. What the study does NOT establish: whether these outcomes are better, equivalent, or worse than outcomes in women not receiving supportive interventions (no control arm), whether any specific intervention is superior to others, whether QOL improvements are causally attributable to the interventions or to natural adaptation over time, or whether the interventions reduce breast cancer recurrence or mortality. The study population was predominantly receiving aromatase inhibitor plus ovarian suppression (95%) at a single Canadian provincial cancer system, limiting generalizability to tamoxifen-only users, diverse ethnic populations, and health systems with different access to complementary care. Women under age 35 represent a higher-risk subgroup with worse outcomes across domains who may warrant more intensive or tailored support — this finding warrants prospective validation. Only the abstract is available; complete statistical details, attrition data, and subgroup analyses cannot be fully evaluated. Results should be interpreted as hypothesis-generating rather than practice-defining. __LIMITATIONS__ No control or comparator arm: outcomes cannot be attributed to the interventions rather than natural disease course, time-effect adaptation, or regression to the mean.,Very small sample size (n=40): severely underpowered to detect subgroup differences or rare harms; results may not be reproducible.,Single-arm design with self-selected interventions introduces substantial selection bias — women motivated to enroll and choose supportive care may differ systematically from the broader population.,Adherence assessed by physician-conducted interviews and pharmacy refill records, both of which are prone to social desirability bias and are imperfect proxies for actual medication ingestion.,Patient self-selection of interventions (rather than randomized allocation) precludes any inference about the efficacy of individual modalities (exercise vs. yoga vs. acupuncture vs. massage).,Homogeneous population (predominantly AI + ovarian suppression, 90% adjuvant radiation, single Canadian province); limits generalizability.,Only abstract-level data available at time of this summary; full methods, attrition, missing data handling, and complete statistical outputs are not assessable.,Slight numerical discrepancies in key outcomes between the published abstract and conference/preprint versions (functional well-being: 1.42 vs. 1.65 pts/yr; p=0.01 vs. p=0.0005) introduce uncertainty about the final reported values.,No reporting of intervention-related adverse events, dropout rates by intervention type, or minimum clinically important difference (MCID) thresholds for FACT instruments, making clinical significance of the functional well-being improvement difficult to contextualize.,Follow-up of up to 3 years may not capture late QOL trajectories or long-term adherence patterns important for a 5–10 year endocrine therapy course. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ The MyCHOICE phase II study found that a patient-directed choice of complementary and behavioral interventions (exercise, massage, acupuncture, yoga) was associated with stable QOL across most domains, a modest improvement in functional well-being, and 92.5% adherence to combination endocrine therapy in 40 premenopausal women with HR-positive breast cancer — but the absence of a control arm means these findings cannot be causally attributed to the interventions. Clinicians may reasonably offer such patient-choice supportive care programs as low-risk adjuncts to standard endocrine therapy, particularly for women at higher risk of QOL decline, while recognizing that this study is hypothesis-generating and not confirmatory. A randomized controlled trial is needed before this approach can be considered evidence-based standard of care.