Dataset Information

Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

ABSTRACT:

Purpose

Weight gain is common among breast cancer patients and may contribute to poorer treatment outcomes. Most programs target breast cancer survivors after the completion of therapy and focus on weight reduction. This study examined the feasibility and preliminary efficacy of an intervention designed to prevent primary weight gain among women receiving neoadjuvant chemotherapy for breast cancer.

Methods

Thirty-eight newly diagnosed stage II or III breast cancer patients were randomized to the BALANCE intervention or usual care within 3 weeks of starting neoadjuvant chemotherapy. The intervention used a size acceptance-based approach and encouraged home-based resistance and moderate-intensity aerobic exercise as well as a low energy-dense diet to prevent weight gain. Assessments were conducted at baseline, mid-chemotherapy (3 months), and post-chemotherapy (6 months). Intervention feasibility, acceptability, and preliminary effects on anthropometric, quality of life, and circulating biomarker measures were evaluated.

Results

Intervention participant retention (100%) and in-person session attendance (80%) were high during the intervention period, although attendance dropped to 43% for telephone-delivered sessions. The majority of participants reported being satisfied with the intervention during chemotherapy (88%). Participants in the intervention group had greater reductions in waist circumference (p = .03) and greater improvements in self-reported vitality scores (p = .03) than the control group at the end of chemotherapy. Significant effects on biomarkers were not observed.

Conclusions

A size acceptance weight management program is feasible during neoadjuvant chemotherapy among breast cancer patients and may have beneficial effects on waist circumference and patient vitality.

Trial registration

This study was registered as a clinical trial at www.clinicaltrials.gov (NCT00533338).

SUBMITTER: Basen-Engquist KM

PROVIDER: S-EPMC8926393 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

Basen-Engquist Karen M KM Raber Margaret M Carmack Cindy L CL Arun Banu B Brewster Abenaa M AM Fingeret Michelle M Schembre Susan M SM Harrison Carol C Perkins Heidi Y HY Li Yisheng Y Song Jaejoon J Chen Minxing M Murray James L JL

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20200405 12

<h4>Purpose</h4>Weight gain is common among breast cancer patients and may contribute to poorer treatment outcomes. Most programs target breast cancer survivors after the completion of therapy and focus on weight reduction. This study examined the feasibility and preliminary efficacy of an intervention designed to prevent primary weight gain among women receiving neoadjuvant chemotherapy for breast cancer.<h4>Methods</h4>Thirty-eight newly diagnosed stage II or III breast cancer patients were ra ...[more]

PMID: 32249355

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Project description:IntroductionAdolescent military-dependents face unique psychosocial stressors due to their parents' careers, suggesting they may be particularly vulnerable to excess weight gain and symptoms of depression and anxiety. Despite these risk factors, there is a lack of tested preventative interventions for these youths. Given the transient nature of military family deployments, research may be hindered due to difficulty in collecting long-term prospective outcome data, particularly measured height and weight. The primary aim of this study was to examine the feasibility and acceptability of collecting body mass index (BMI, kg/m2) outcome data up to 2 years following a randomized controlled pilot trial of an adapted interpersonal psychotherapy (IPT) program aimed at preventing excess weight gain and improving psychological functioning for adolescent military-dependents. In exploratory analyses, patterns in body composition over time were examined.Materials and methodsTwenty-seven adolescent military-dependent girls (baseline: Mage: 14.4 ± 1.6 years; MBMI: 30.7 ± 4.9 kg/m2; MBMI-z: 1.9 ± 0.4) participated in this study. After a baseline assessment, utilizing a computerized program to create a randomization string, girls were assigned to either an IPT or a health education (HE) program. Participants completed three follow-up visits (posttreatment, 1-year follow-up, and 2-year follow-up). Girls completed a Treatment Acceptability Questionnaire at posttreatment; at all time points, height and fasting weight were collected. For the primary aim, Fisher's exact tests examined the rate of obtained follow-up data and lost to follow-up status between the two groups, Mann-Whitney U tests examined the session attendance between groups, and treatment acceptability ratings were compared between the two groups at posttreatment using an independent samples t-test. For the exploratory aim, one-way analyses of covariance (ANCOVAs) examined the group differences in BMI at each time point, adjusting for baseline values, and paired samples t-tests examined the within-group differences at each time point relative to baseline. Using imputed data in the full intent-to-treat sample, mixed model ANCOVAs were conducted to examine the group differences over time.ResultsAcross both groups, girls attended an average of 72.0% of sessions. At least partial data were collected at posttreatment, 1-year follow-up, and 2-year follow-up for 96.3%, 85.2%, and 74.1% of the participants, respectively. There were no significant group differences in follow-up data collection rates, follow-up status, number of sessions attended, or treatment acceptability. BMI-z stabilized across groups, and there were no group differences in BMI-z. In adjusted ANCOVA models with imputed data, no significant group-by-time effects emerged.ConclusionsFor this randomized controlled prevention trial, long-term outcome data collection of measured BMI was possible in adolescent military-dependents and IPT was an acceptable and feasible intervention. An adequately powered trial is required to assess the efficacy of this intervention among military-dependents for obesity prevention and improvements in BMI.

Project description:BackgroundThis study assessed the initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain.MethodsThis pilot 2x2 factorial randomized control trial used a mixed-methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV+PI) to mitigate accelerated summer body mass index (BMI) gain. Progression criteria for feasibility and efficacy were assessed to determine if a full-scale trial was warranted. Feasibility criteria included recruitment capability (≥80 participants recruited) retention (≥70% participants retained), compliance (≥80% of participants attending the summer program with children attending ≥60% of program days, and ≥80% of participants completing goal setting calls with ≥60% of weeks syncing their child's Fitbit), and treatment fidelity (≥80% of summer program days delivered for ≥9 h/day, and ≥80% of participant texts delivered). Efficacy criteria were assessed via achieving a clinically meaningful impact on zBMI (i.e., ≥0.15). Changes in BMI were estimated using intent-to-treat and post hoc dose-response analyses via multilevel mixed-effects regressions.ResultsFor recruitment, capability and retention progression criteria were met with a total of 89 families participating and 24 participants randomized to the PI group, 21 randomized to the SCV group, 23 randomized to the SCV+PI group, and 21 randomized to the control. However, fidelity and compliance progression criteria were not achieved due to COVID-19 and lack of transportation. Progression criteria for efficacy was also not achieved as intent-to-treat analyses did not show changes in BMI gain that were clinically meaningful. Post hoc dose-response analyses showed that for each day (0 to 29) of summer programming children attended they gained -0.009 (95CI= -0.018, -0.001) less in BMI z score.ConclusionsEngagement in both the SCV and PI was not ideal due to COVID-19 and lack of transportation. Providing children with structured summer programming to mitigate accelerated summer BMI gain may be an effective strategy. However, because feasibility and efficacy progression criteria were not met, a larger trial is not warranted until further pilot work is completed to ensure children attend the programming.Trial registrationThe trial reported herein was prospectively registered at ClinicalTrials.gov. Trial #: NCT04608188.

Project description:PurposeTo determine characteristics of weight gain prevention programs that facilitate engagement.DesignRandomized factorial experiment (5 × 2).SettingRecruited nationally online.ParticipantsAdults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498).MeasuresParticipants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only; physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring). Participants reported willingness to join the programs, perceived program effectiveness, and reasons for declining enrollment.AnalysisLogistic regression and linear regression to test effects of program characteristics offered on willingness to initiate programs and programs' perceived effectiveness, respectively. Content analyses for open-ended text responses.ResultsParticipants offered the self-weighing-only programs were more willing to initiate than those offered the programs targeting all 3 behaviors combined (50% vs 36%; odds ratio [OR] = 1.79; 95% confidence interval [CI], 1.01-3.13). Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34, P = .02) than those offered no financial incentives. Reasons for declining to initiate included specific program features, behavior targets, social aspects, and benefits.ConclusionTargeting self-weighing and providing financial incentives for self-monitoring may result in greater uptake of weight gain prevention programs.Study preregistrationhttps://osf.io/b9zfh, June 19, 2018.

Project description:PurposeTo evaluate the feasibility of a home-based moderate-to-vigorous intensity, phased (introduction, intermediate, maintenance), exercise prescription in breast cancer patients receiving cardiotoxic neoadjuvant chemotherapy.MethodsNineteen breast cancer patients were randomized to intervention or control for the duration of chemotherapy (16-24 weeks). The intervention was one aerobic exercise session at 80-90% VO2max for 25 min/week and 65%-75% VO2max for ≥ 50 min/week. Adherence to the tailored home-based program was assessed by heart rate monitors. Acceptability, tolerability, feasibility, efficacy, change in VO2max, and patient reported outcomes, safety, and clinical events were assessed.Results25.7% of eligible women consented (acceptability). Adherence was 87.6%. Women were not able to maintain exercise intensity as chemotherapy progressed (23.7% of exercise minutes were completed at prescribed heart rate during maintenance). Efficacy of the intervention was demonstrated by maintenance of VO2max (-1.0 ± 13.2%) compared to (-27.5 ± 7.4%) the control group. Further, during and after therapy, patients in the intervention arm reported less fatigue (control-baseline: 14.4 ± 15.9; midpoint: 19.0 ± 11.4; follow-up: 29.4 ± 20.0; intervention-baseline: 29.2 ± 24.6; midpoint: 24.6 ± 14.4; follow-up: 23.6 ± 11.9), impairment in activities (control-baseline: 13.7 ± 16.0; midpoint: 32.8 ± 17.0; follow-up: 58.6 ± 27.9; intervention-baseline: 38.7 ± 31.8; midpoint: 47.1 ± 27.5; follow-up: 47.5 ± 31.0), and pain (control-baseline: 80.8 ± 17.1; midpoint: 73.9 ± 20.7; follow-up: 50.7 ± 25.7; intervention-baseline: 68.7 ± 28.4; midpoint: 61.4 ± 22.5; follow-up: 65.3 ± 22.4). There were no differences in adverse events, treatment delays, or pathological complete response.ConclusionsNeoadjuvant breast cancer patients maintained approximately one hour/week of moderate-intensity exercise over the course of their treatment. Further, this volume of exercise was sufficient to maintain fitness capacity and quality of life compared to the control group.Trial registryClinicalTrials.gov Identifier: NCT03280836, prospectively registered 9/13/2017, https://clinicaltrials.gov/ct2/show/NCT03280836 .

Dataset Information

Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

Purpose

Methods

Results

Conclusions

Trial registration

Publications

Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study.

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