Dataset Information

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer.

ABSTRACT:

Purpose

To explore the feasibility, adherence, safety and potential efficacy of Every Day Counts; a randomized pilot trial designed for women with metastatic breast cancer (MBC) framed by the American Cancer Society nutrition and physical activity (PA) guidelines METHODS: Women with clinically stable MBC were recruited to complete an interview, dual energy X-ray absorptiometry imaging and phlebotomy at baseline and post-intervention. Multidimensional quality of life, symptom burden, lifestyle behaviors (nutrition and PA) and biomarkers of prognosis were procured and quantified. Women were randomized to the immediate intervention or a waitlist control arm. The 12-week intervention included a curriculum binder, lifestyle coaching (in-person and telephone-based sessions) and intervention support (activity monitor, text messaging, cooking classes.) Women in the waitlist control were provided monthly text messaging.

Results

Forty women were recruited within 9 months (feasibility). Women in the immediate intervention attended 86% of all 12 weekly coaching sessions (adherence) and showed significant improvements in general QOL (p = 0.001), and QOL related to breast cancer (p = 0.001), endocrine symptoms (p = 0.002) and fatigue (p = 0.037), whereas the waitlist control did not (all p values ≥ 0.05) (efficacy). PA significantly increased for women in the intervention compared to control (p < 0.0001), while dietary changes were less evident across groups due to high baseline adherence. No significant changes in biomarkers or lean mass were noted, yet visceral adipose tissue declined (p = 0.001). No intervention-related injuries were reported (safety). Qualitative feedback strongly supports the desire for a longer intervention with additional support.

Conclusions

Lifestyle interventions are of interest, safe and potentially beneficial for women with MBC. A larger trial is warranted.

SUBMITTER: Sheean P

PROVIDER: S-EPMC8206042 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer.

Sheean Patricia P Matthews Lauren L Visotcky Alexis A Banerjee Anjishnu A Moosreiner Andrea A Kelley Kimberly K Chitambar Christopher R CR Papanek Paula E PE Stolley Melinda M

Breast cancer research and treatment 20210319 3

<h4>Purpose</h4>To explore the feasibility, adherence, safety and potential efficacy of Every Day Counts; a randomized pilot trial designed for women with metastatic breast cancer (MBC) framed by the American Cancer Society nutrition and physical activity (PA) guidelines METHODS: Women with clinically stable MBC were recruited to complete an interview, dual energy X-ray absorptiometry imaging and phlebotomy at baseline and post-intervention. Multidimensional quality of life, symptom burden, life ...[more]

PMID: 33742324

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Project description:BackgroundThere is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer.ObjectiveThe Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters.MethodsThe ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations.ResultsOverall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, P<.001) and isometric quadriceps strength (+22%, P<.001), as well as decreases in body mass index (-2.5%, P=.03) and hip circumference (-4.0%, P<.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, P=.07) in fatigue was observed.ConclusionsThe high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted.Trial registrationClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886.

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Project description:BackgroundDespite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes.ObjectiveThis study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community.MethodsUsing a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed.ResultsThe intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; P<.001). In addition, the intervention group rated satisfaction with the intervention (P=.003), effectiveness of the intervention (P<.001), and increase of knowledge on breast cancer and screenings (P=.001) significantly higher than the control group.ConclusionsA mobile phone app-based intervention combined with health navigator service was a feasible, acceptable, and effective intervention mechanism to promote breast cancer screening in Korean American immigrant women. A flexible, easily tailored approach that relies on recent technological advancements can reach underserved and hard-to-recruit populations that bear disproportionate cancer burdens.Trial registrationClinicaltrials.gov NCT01972048; https://clinicaltrials.gov/show/NCT01972048 (Archived by WebCite at https://clinicaltrials.gov/archive/NCT01972048/2013_10_29).

Project description:RationaleVideo-based interventions hold promise for improving quality of life (QoL) among African American breast cancer patients.ObjectiveAn interactive, cancer-communication intervention using African American breast cancer survivors' narratives was tested in a randomized controlled trial to determine whether viewing survivor stories improved newly diagnosed African American breast cancer patients' QoL.MethodParticipants were 228 African American women with non-metastatic breast cancer interviewed five times over two years; 120 controls received standard medical care, and 108 intervention-arm participants also received a tablet-computer with survivor stories three times in 12 months. Growth curve models were used to analyze differences between arms in change in eight RAND 36-Item Health Survey subscales, depressive symptoms, and concerns about recurrence. Additional models explored the effects of intervention usage and other intervention-related variables on QoL among patients in the intervention arm.ResultsModels showed no effect of study arm on QoL, depressive symptoms, or concerns about recurrence. Longer use of the intervention was associated with an increase in concerns about recurrence and decline in three QoL subscales: emotional wellbeing, energy/fatigue, and role limitations due to physical health.ConclusionAlthough no significant impact of the intervention on QoL was observed when comparing the two study arms, in the intervention arm longer intervention use was associated with declines in three QoL subscales and increased concerns about recurrence. Women with improving QoL may have interacted with the tablet less because they felt less in need of information; it is also possible that encouraging patients to compare themselves to survivors who had already recovered from breast cancer led some patients to report lower QoL. Future work is warranted to examine whether adding different stories to this cancer-communication intervention or using stories in conjunction with additional health promotion strategies (e.g., patient navigation) might improve QoL for African American breast cancer patients.

Dataset Information

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer.

Purpose

Results

Conclusions

Publications

Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer.

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