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.

OBJECTIVE: Non-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. METHODS: This 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. RESULTS: Of 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). CONCLUSIONS: The 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 REGISTRATION: ISRCTN12027752.

Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study.

AIM: The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112). MATERIALS AND METHODS: Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires. RESULTS: One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%). CONCLUSION: Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.

Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study.

BACKGROUND: Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients. METHODS/DESIGN: MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat. DISCUSSION: The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group. TRIAL REGISTRATION: Netherlands Trial Register: NL6281/NTR6455 . Registered 18 May 2017, https://www.trialregister.nl/trial/6281.

Impact of changes in perceived attentional function on postsurgical health-related quality of life in breast cancer patients awaiting adjuvant treatment.

PURPOSE: Few studies have assessed pre-surgery cognitive impairment or the impact of pre-surgery cognitive impairment on quality of life. The purpose of this study was to assess changes in perceived cognitive function from pre-surgery to 1 month post-surgery and to determine whether cognitive function predicted health-related quality of life in women who awaited adjuvant treatment for breast cancer. METHODS: This study used a descriptive pre-post design to assess women newly diagnosed with breast cancer prior to any treatment (N = 132). Cognition was assessed using the Attentional Function Index (AFI) and health-related quality of life was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G). Statistical methods included descriptive, comparative and regression analyses. Covariates assessed and controlled for in analyses included depressed mood, fatigue, disturbed sleep, surgery-related symptoms (lymphedema/decreased mobility), and cultural tendency. RESULTS: Perceived attention and memory function decreased from pre-surgery to 1 month post-surgery alongside alterations in arm function and a decrease in depressed mood (p < 0.05). Regression analysis indicated that, after controlling for covariates, poorer perceived attention and memory function, surgery-specific symptoms, and a greater tendency toward collectivism predicted poorer quality of life. CONCLUSION: Perceived function on tasks requiring attention and working memory 1 month post-surgery was poorer compared to pre-surgery suggesting that the mental and physical demands of a new diagnosis of breast cancer and surgery may effect cognitive function. Additionally, changes in perceived cognitive function significantly predicted perceived quality of life in women awaiting adjuvant treatment for breast cancer. Findings suggest that breast cancer patients are at risk for an early decline in cognitive function and that interventions aimed at supporting and optimizing function may improve quality of life early in the disease trajectory.

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

BACKGROUND: Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors. METHODS: An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ2 test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ2 test and logistic regression was used for estradiol. Analysis was based on intention-to-treat. RESULTS: A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups. CONCLUSION: SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.

The Efficacy of Software to Help Patients Understand Drug for Adjuvant Treatment for Breast Cancer: A Pilot Randomized Controlled Trial.

We assessed the usefulness of ChemoCalc, a software package for calculating drug costs, in helping patients understand these costs. We randomly assigned, in a 1 : 1 ratio, 20 women who had undergone surgery for early breast cancer to a group that discussed adjuvant treatment with their physicians using the ChemoCalc software (ChemoCalc group) or a group that discussed adjuvant treatment without ChemoCalc (Usual Explanation group). The participants completed a five-grade evaluation questionnaire after these discussions. The primary endpoint was the intergroup comparison of the questionnaire scores regarding participants' understanding of their treatment-associated drug costs. Median age was not significantly different between the ChemoCalc group and Usual Explanation group (57 vs. 50, respectively; p=0.27). Patients in the ChemoCalc group had a significantly higher perceived level of understanding of the drug cost than those in the Usual Explanation group (5 [4-5] vs. 2.5 [1-5], respectively; p=0.002). Scores related to the patients' perception that understanding drug costs is an important part of breast cancer treatment were also higher in the ChemoCalc group than the Usual Explanation group (5 [2-5] vs. 3 [1-5], respectively; p=0.049). ChemoCalc was found to be useful for understanding drug costs.

Correlates of Adjuvant Therapy Attitudes in African American Breast Cancer Patients.

PURPOSE: Black breast cancer patients delay and underutilize adjuvant breast cancer therapies; yet, very few studies have specifically examined Black women's attitudes toward breast cancer therapy. This study observed the influence of self-reported interpersonal processes of care (e.g. self-efficacy) clinical and sociodemographic factors and sociocultural (e.g. religiosity), related to Black breast cancer patients' attitudes toward radiation and systemic therapies (chemotherapy and adjuvant endocrine therapy - "AET"). METHODS: This was a secondary analysis of data from the Narrowing Gaps in Adjuvant Therapy Study (2006-2011). The analysis included 210 Black women who were newly diagnosed with breast cancer. Bivariate and multiple regression analyses were performed between independent variables (e.g., demographics) and three outcome variables (chemotherapy, AET, and radiation therapy) to asses women's perceptions of therapy type. The lasso method was used to select variables correlated with therapy attitudes. RESULTS: Most women reported negative attitudes toward AET (56%) and radiation (54%); fewer negative attitudes were observed toward chemotherapy (47%). Higher education and greater perceived susceptibility of a recurrence were associated with more positive attitudes toward chemotherapy. Regarding radiation therapy, women with greater patient satisfaction were more likely to have more positive attitudes. CONCLUSIONS: Our study findings may aid in the development of behavioral interventions targeted to mitigate Black women breast cancer treatment disparities. We found modifiable factors (e.g. communication, satisfaction ratings) that support opportunities for clinicians to better address Black women's needs regarding adjuvant treatment options. The development of tailored interventions for newly diagnosed Black breast cancer patients on patient related factors in health care are warranted for Black women with lower educational levels.

Long-Term Favorable Effects of Physical Exercise on Burdensome Symptoms in the OptiTrain Breast Cancer Randomized Controlled Trial.

Purpose: We evaluate longitudinal changes in symptom clusters and core burdensome symptoms in breast cancer patients who participated in the OptiTrain trial. Methods: 240 women were randomized to 16 weeks of supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy. Symptom clusters were composed using the Memorial Symptom Assessment Scale (MSAS), assessed at baseline, 16 weeks and 12 months later. Three symptom clusters were formed. Results: Three symptom clusters were identified: "emotional," "treatment-related toxicity," and "physical," with core burdensome symptoms present over time. At 16 weeks, the reported burdens of "feeling sad" (RT-HIIT vs UC: effect size [ES] = -0.69; AT-HIIT vs UC: ES = -0.56) and "feeling irritable" (ES = -0.41 RT-HIIT; ES = -0.31 AT-HIIT) were significantly lower in both intervention groups compared with UC. At 12 months, the AT-HIIT group continued to have significantly lower scores for the core burdensome symptoms "feeling sad" (ES = -0.44), "feeling irritable" (ES = -0.44), and "changes in the way food tastes" (ES = -0.53) compared with UC. No between-group differences were found for physical symptoms. Conclusion: We identified 3 symptom clusters in breast cancer patients during and after adjuvant chemotherapy, composed of "emotional," "treatment-related toxicity," and "physical" symptoms. After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC. Our findings indicate a preserved and long-term beneficial effect of physical exercise on self-reported emotional well-being in chemotherapy-treated breast cancer patients.

Breast cancer patients' experiences of adherence and persistence to oral endocrine therapy: A qualitative evidence synthesis.

PURPOSE: Adjuvant endocrine therapy (AET) significantly reduces the risk of breast cancer recurrence and mortality in women with hormone receptor (HR+) breast cancer. Despite the documented survival benefits with AET, non-adherence and non-persistence remains a significant problem. This systematic review of qualitative research aimed to synthesise breast cancer patients' experiences of adherence and persistence to oral endocrine therapy. METHODS: The ENTREQ guidelines were followed. A systematic search strategy was performed across eleven electronic databases (Embase, Cinahl, Pubmed, Psychinfo, Proquest, Lenus, Scopus, Web of Science, Rian.ie, EThOS e-theses online, DART Europe). Thomas and Harden's three-stage approach to thematic analysis was undertaken on the findings of all included studies. Confidence in the findings were reviewed using GRADE-CERQual. RESULTS: Twenty-four qualitative studies were included in the synthesis. Three analytic themes were identified (We don't have an option; the side effects are worse than the disease; help us with information and support). Adherence was often driven by women feeling they had no option and a fear of cancer recurrence. Persistence was helped with support and information. Non-adherence and non-persistence were associated with debilitating side effects, inadequate information and lack of support. CONCLUSIONS: Adherence and persistence to AET was often suboptimal among breast cancer patients. Women commonly felt isolated and neglected as a result of insufficient information and support from healthcare professionals. If women are to persist with AET, primary care providers should be aware of the facilitators and barriers to adherence, and they should be knowledgeable in symptom management strategies.

Major depression but not minor to intermediate depression correlates with unfavorable prognosis in surgical colorectal cancer patients underwent adjuvant chemotherapy.

This study aimed to investigate the correlation of anxiety/depression with clinicopathological features, and the association of anxiety/depression degrees with overall survival (OS) in surgical colorectal cancer (CRC) patients. Three hundred and eighty-one surgical CRC patients were consecutively enrolled and underwent adjuvant chemotherapy accordingly. Anxiety and depression were assessed by the Hospital Anxiety and Depression Scale (HADS). Patients with no, minor, intermediate and major anxiety were 249 (65.4%), 79 (20.7%), 37 (9.7%) and 16 (4.2%), respectively, and patients with no, minor, intermediate and major depression were 231 (60.6%), 73 (19.2%), 44 (11.5%) and 33 (8.7%), respectively. Younger age, increased the pathological grade, elevated tumor, node and metastasis (TNM) stage, as well as higher education correlated with raised HADS-A score, while younger age, drinking history, increased pathological grade, elevated TNM stage and higher education associated with raised HADS-D score. There was no difference in OS among CRC patients with no anxiety, minor anxiety, intermediate anxiety and major anxiety. And CRC patients with major depression were of worse OS compared to those with no depression, minor depression or intermediate depression. Younger age, higher pathological grade, TNM stage and education associates with anxiety and depression, and major depression is negatively correlated with OS in surgical CRC patients underwent adjuvant chemotherapy.

Sense of coherence and health-related quality of life in patients with neurotoxicity after cancer chemotherapy: Assessment from a real-time mobile phone-based system.

OBJECTIVE: In the present study, we aimed to assess sense of coherence (SOC) and health-related quality of life (HRQOL) during and after adjuvant chemotherapy by mobile phone-based reporting in patients with colorectal cancer experiencing neurotoxicity. METHODS: In this prospective descriptive cohort study, a mobile phone-based system was used to receive a series of real-time longitudinal patient-reported assessments of SOC (13-item), HRQOL (Functional Assessment of Cancer Therapy-General (FACT-G) 27-item), and neurotoxicity (OANQ 29-item) from 43 patients with colorectal cancer after being treated with chemotherapy including oxaliplatin. Measurements were conducted during the whole treatment period (mean 5 cycles) and up to 12 months after completing chemotherapy. RESULTS: In total, 817 questionnaire responses (226 SOC, 221 FACT-G, 370 OANQ) answered during and after chemotherapy treatment were available for analysis. Even though all patients experienced neurotoxicity during the treatment period, HRQOL was stable over time. Over time, the ratings of physical wellbeing tended to increase, while the subscale of social wellbeing tended to decrease. Overall SOC, including the three components comprehensibility, manageability, and meaningfulness was stable during the entire study period. No internal data was missing due to the mobile phone-based system. CONCLUSIONS: All patients had neurotoxicity during the treatment period that seemed to affect the social wellbeing component of HRQOL, but SOC seemed unaffected. Real-time patient-reported assessment using mobile phone technology could be valuable in the clinical setting to provide continuous individualised monitoring to help identify patients who need further evaluation to maintain or improve their psychosocial health.

Patients' self-report anxiety, depression and quality of life and their predictive factors in muscle invasive bladder cancer patients receiving adjuvant chemotherapy.

This study aimed to evaluate anxiety, depression and quality of life (QoL) by patients' self-report scales and the predictive factors for their aggravation in muscle invasive bladder cancer (MIBC) patients receiving adjuvant chemotherapy. One hundred and ninety-four MIBC patients who received adjuvant chemotherapy and underwent radical cystectomy were consecutively enrolled. HADS was used to evaluate anxiety and depression, and EORTC QLQ-C30 Scale was used to assess QoL. Post adjuvant chemotherapy, HADS-Anxiety score (P = 0.042), anxiety percentage (P = 0.036), HADS-Depression score (P < 0.001), depression percentage (P = 0.002) and the EORTC QLQ-C30 Functional score (P = 0.002) were elevated compared with baseline. Age (P < 0.001), BMI (P = 0.021) and hypertension (P = 0.001) correlated with aggravation of HADS-Anxiety score, while gender (P < 0.001) correlated with aggravation of HADS-Depression score independently during adjuvant chemotherapy. And smoking, alcohol use, hypertension, diabetes, ECOG performance, pT stage as well as pN stage independently predicted the worsening of EORTC QLQ-C30 Scale subscale scores during adjuvant chemotherapy (all P < 0.05). In conclusion, patients' self-report anxiety and depression were increased while QoL was not deteriorated in MIBC patients during adjuvant chemotherapy, and age, gender, BMI, hypertension, smoking, alcohol use, diabetes, ECOG performance, pT stage as well as pN stage were potential predicting factors for their aggravation.

Effect of a patient education and rehabilitation program on anxiety, depression and quality of life in muscle invasive bladder cancer patients treated with adjuvant chemotherapy.

This study aimed to investigate the effect of a patient education and rehabilitation program (PERP) on anxiety, depression, and quality of life in muscle invasive bladder cancer (MIBC) patients underwent adjuvant chemotherapy.One hundred and thirty MIBC patients about to receive adjuvant chemotherapy with 4-cycle gemcitabine and cisplatin (GC) regimen (16 weeks) were consecutively enrolled and randomly allocated into PERP group and control group as 1:1 ratio. Hospital Anxiety and Depression Scale (HADS) anxiety and depression scores and Quality of Life Questionnaire (QLQ-C30) scores were assessed before treatment (W0) and after treatment (W16).After 16-week treatment, PERP group exhibited decreased HADS anxiety score (P = .036), ΔHADS anxiety score (W16-W0) (P < .001) and percentage of anxiety patients (P = .019) compared to control group. And PERP group presented with numerically reduced HADS depression score but without statistical significance (P = .076) compared to control group, while lower ΔHADS depression score (W16-W0) (P = .014) and percentage of depression patients (P = .015) compared to control group. As to quality of life, QLQ-C30 global health status score (P = .032), Δglobal health status score (W16-W0) (P = .003) and Δfunctional score (W16-W0) (P = .005) were higher in PERP group compared to control group. However, no difference of QLQ-C30 functional score (P = .103), QLQ-C30 symptom score (P = .808) or Δsymptom score (W16-W0) (P = .680) was observed between two groups.PERP relieves anxiety, depression and improves quality of life in MIBC patients underwent adjuvant chemotherapy.

[Adjuvant hormonal therapy for early breast cancer: Assessment of patients' satisfaction]. / Évaluation de la satisfaction de patientes atteintes d'un cancer du sein précoce traitées en adjuvant par hormonothérapie.

INTRODUCTION: Since the cancer plan, evaluation of professional practices is essential to ensure the implementation of high-quality health care. Assess patient satisfaction is one of the pillars of high-quality health care. The main objective of the study was to assess the satisfaction of patients with early breast cancer taking a hormonal therapy, the secondary objective was to identify factors associated with their satisfaction. METHODS: The modified EORTC OUT-PATSAT-35 questionnaire was sent to a sample of patients in Franche-Comté in order to evaluate nine dimensions of satisfaction among which interpersonal skills, provided information, and overall satisfaction. For each dimension, a satisfaction score between 0 (no satisfaction) and 100 (highest satisfaction) was measured. Logistic regression analyses were used to study the factors associated with satisfaction. RESULTS: The mean overall satisfaction score for the 280 patients who answered was 73 [0-100]. Practicing an extra-professional activity was associated with higher satisfaction for several dimensions (odds ratio between 2.80 and 4.12, P<0.05) whereas it was decreased in the case of a modified appetite (odds ratio between 0.27 and 0.52, P<0.05). No link has been shown between satisfaction and adherence. DISCUSSION: The patients were satisfied and several factors impacting their satisfaction were identified, based on a questionnaire that must evolve to take into account the ambulatory aspect of their care. During the consultations, particular attention will be paid to these factors.

Patient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.

BACKGROUND: Neoadjuvant systemic therapy (NAST) is used for large operable or highly proliferative breast cancers. It is not known whether psychological outcomes differ according to the treatment sequence (chemotherapy or surgery first) or tumour response. METHODS: This was a planned analysis of a multi-institutional single arm longitudinal study of patients considering NAST for operable breast cancer. Participants completed patient reported outcome questionnaires before and after the decision about NAST, between chemotherapy and surgery, and 12 months after diagnosis. RESULTS: Fifty-nine women enrolled. Fourteen of 51 (28%) who received NAST experienced pathological complete response (pCR). Patients who had surgery first (n = 7) had higher baseline anxiety, and a greater decrease in anxiety at 12 months follow up, compared with patients who received NAST (n = 50) (a decrease from baseline of 34 pts vs 17 points; p = 0.033). Distress declined at a similar rate in surgery first and NAST groups. Mean satisfaction with decision score post-decision was significantly lower in the adjuvant group compared with NAST (22 vs 26, p = 0.02). No differences were seen between patients with pCR vs residual cancer in: distress, anxiety, satisfaction with decision, fear of progression, and decision regret. CONCLUSION: Most patients in this study proceeded with NAST when their surgeon offered it as an option. This exploratory analysis suggests that patients who chose surgery first tended to be more anxious, and had lower satisfaction with their decision, than those who had NAST. In patients who had NAST, lack of pCR does not appear to correlate with adverse psychological outcomes.

Relationship of fatigue with cognitive performance in women with early-stage breast cancer over 2 years.

OBJECTIVE: Fatigue and cognitive dysfunction are major concerns for women with early-stage breast cancer during treatment and into survivorship. However, interrelationships of these phenomena and their temporal patterns over time are not well documented, thus limiting the strategies for symptom management interventions. In this study, changes in fatigue across treatment phases and the relationship among fatigue severity and its functional impact with objective cognitive performance were examined. METHODS: Participants (N = 75) were assessed at five time points beginning prior to chemotherapy to 24 months after initial chemotherapy. Fatigue severity and impact were measured on the Brief Fatigue Inventory. Central nervous system (CNS) Vital Signs was used to measure performance based cognitive testing. Temporal changes in fatigue were examined, as well as the relationship between fatigue and cognitive performance, at each time point using linear mixed effect models. RESULTS: Severity of fatigue varied as a function of phase of treatment. Fatigue severity and its functional impact were moderate at baseline, increased significantly during chemotherapy, and returned to near baseline levels by 2 years. At each time point, fatigue severity and impact were significantly associated with diminished processing speed and complex attention performance. CONCLUSIONS: A strong association between fatigue and objective cognitive performance suggests that they are likely functionally related. That cognitive deficits were evident at baseline, whereas fatigue was more chemotherapy dependent, implicates that two symptoms share some common bases but may differ in underlying mechanisms and severity over time. This knowledge provides a basis for introducing strategies for tailored symptom management that vary over time.

A qualitative comparison of how older breast cancer survivors process treatment information regarding endocrine therapy.

BACKGROUND: It remains unclear how information about aromatase inhibitors (AI) impacts women's decision-making about persistence with endocrine therapy. PURPOSE: To describe and compare how women treated for primary early stage breast cancer either persisting or not persisting with an AI received, interpreted, and acted upon AI-related information. DESIGN: Thematic analysis was used to sort and compare the data into the most salient themes. PARTICIPANTS: Women (N = 54; 27 persisting, 27 not persisting with an AI) aged 65-93 years took part in qualitative interviews. RESULTS: Women in both subgroups described information similarly in terms of its value, volume, type, and source. Aspects of AI-related information that either differed between the subgroups or were misunderstood by one or both subgroups included: (1) knowledge of AI or tamoxifen prior to cancer diagnosis, (2) use of online resources, (3) misconceptions about estrogen, hormone replacement therapies and AI-related symptoms, and (4) risk perception and the meaning and use of recurrence statistics such as Oncotype DX. CONCLUSIONS: Persisters and nonpersisters were similar in their desire for more information about potential side effects and symptom management at AI prescription and subsequent appointments. Differences included how information was obtained and interpreted. Interactive discussion questions are shared that can incorporate these findings into clinical settings.

Validity and Reliability of the Decision Regret Scale in Cancer Patients Receiving Adjuvant Chemotherapy.

OBJECTIVES: Decisional regret is an indicator of satisfaction with the treatment decision and can help to identify those patients who need more support and evaluate the efficacy of decision support interventions. The objectives of this study are, 1) to evaluate the psychometric properties of the Decision Regret Scale and 2) to analyze the moderating effect of psychological distress on functional status and regret in patients with cancer following adjuvancy. METHODS: A prospective, multicenter cohort of 403 patients who completed the Decision Regret Scale (DRS), Health-Related Quality of Life (EORTC QLQ-C30), and Brief Symptom Inventory (BSI). The evaluation was conducted six months after receiving adjuvant treatment in patients with resected cancer. RESULTS: After treatment, most participants (51.9%) experienced no decision regret; 33.7% felt mild regret, and 14.4% exhibited high levels of regret. The Spanish version of the DRS demonstrated satisfactory properties: it had a strong, clear unidimensional factorial structure with substantial loadings. Decisional regret was related with lower scores on functional, symptom, and quality of life scales, and higher levels of psychological distress (all P = 0.001). Psychological distress was found to have a moderating effect on the relationship between functional state and decision regret. CONCLUSIONS: The Spanish version of the DRS is a reliable, valid tool to evaluate regret and post-decisional quality in clinical practice and further highlights the potential clinical implications of psychological distress for the relation between physical status and regret.

Decision-making under clinical uncertainty: An in-depth examination of provider perspectives on adjuvant chemotherapy for stage II colon cancer.

OBJECTIVE: Decision-making about adjuvant chemotherapy (ACT) for stage II colon cancer is complex, particularly in light of clinical uncertainty regarding treatment benefits. Little is known about provider communication and factors influencing decision-making and recommendations in this setting. METHODS: We recruited providers from six US cancer centers and hospitals who care for stage II colon cancer patients. Providers participated in a 30-45 minute interview. Transcripts of interviews were coded for qualitative analysis. RESULTS: We interviewed 42 providers (Oncologists: 52%; surgeons: 24%; nurses: 14%). Though most providers were aware of stage II colon cancer treatment guidelines, their use and communication of recommended guidelines was limited. Most reported tailoring delivery and content of their communication, often based on perceived patient education level, but patient involvement in decision-making varied. Findings highlight the complexity of, ACT decision-making, including the central role of providers and family members. CONCLUSIONS: Providers are not consistently following recommended guidelines for communicating about ACT among stage II colon cancer patients or eliciting patient preferences for involvement in treatment decisions. PRACTICE IMPLICATIONS: Given clinical uncertainty surrounding use of ACT for stage II colon cancer, efforts are needed to enhance guideline implementation, provider education, and communication to facilitate decision-making.

The impact of gene expression profile testing on confidence in chemotherapy decisions and prognostic expectations.

PURPOSE: Little is known about whether gene expression profile (GEP) testing and specific recurrence scores (e.g., medium risk) improve women's confidence in their chemotherapy decision or perceived recurrence risk. We evaluate the relationship between these outcomes and GEP testing. METHODS: We surveyed women eligible for GEP testing (stage I or II, Gr1-2, ER+, HER2-) identified through the Surveillance, Epidemiology, and End Results (SEER) Registry of Washington or Kaiser Permanente Northern California from 2012 to 2016, approximately 0-4 years from diagnosis (N = 904, RR = 45.4%). Confidence in chemotherapy was measured as confident (Very, completely) versus Not Confident (Somewhat, A little, Not At All); perceived risk recurrence was recorded numerically (0-100%). Women reported their GEP test receipt (Yes, No, Unknown) and risk recurrence score (High, Intermediate, Low, Unknown). In our analytic sample (N = 833), we propensity score weighted the three test receipt cohorts and used propensity weighted multivariable regressions to examine associations between the outcomes and the three test receipt cohorts, with receipt stratified by score. RESULTS: 29.5% reported an unknown GEP test receipt; 86% being confident. Compared to no test receipt, an intermediate score (aOR 0.34; 95% CI 0.20-0.58), unknown score (aOR 0.09; 95% CI 0.05-0.18), and unknown test receipt (aOR 0.37; 95% CI 0.24-0.57) were less likely to report confidence. Most women greatly overestimated their recurrence risk regardless of their test receipt or score. CONCLUSIONS: GEP testing was not associated with greater confidence in chemotherapy decisions. Better communication about GEP testing and the implications for recurrence risk may improve women's decisional confidence.