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A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors.

ABSTRACT: OBJECTIVE:The objective of the study is to test theoretical intervention fidelity and feasibility of MOVING ON, a self-directed, home-based, randomized controlled trial to increase exercise outcome expectations (OEs) (what one expects to obtain or avoid as a result of a behavior or lack thereof), among breast cancer survivors. METHOD:Stage Ia to IIb survivors (n = 60) were given the MOVING ON intervention or control booklet. Data were collected through online surveys and an accelerometer at baseline, 4, 8, and 12 weeks postintervention. Fidelity was measured by questions assessing participant perceptions of MOVING ON (score ?2) and direction of intervention effects. Feasibility was measured by recruitment rate (target of 60 participants in 6 months), retention (total attrition <17%), and acquisition of accelerometer data (% ?subjective exercise data obtained). Analyses consisted of descriptive statistics, mixed models, and content analysis. RESULTS:Fidelity met a priori criteria (mean = 3.31, SD = 0.87). Outcome expectations increased 0.01 points, and weekly steps increased by 970 every 4 weeks in the intervention arm compared to the control arm. All effect sizes were small, ranging from 0.01 to 0.09. Target enrollment, achieved in 17 weeks, met a priori feasibility criteria. Retention (66%) and accelerometer data acquisition (60%) (compared to 73% of subjective exercise data) did not. CONCLUSION:MOVING ON influenced OEs as intended and was well received by participants. A fully powered study, of this low-cost, easy-to-implement intervention, is warranted. Intervention and measurement strategies used in MOVING ON can be incorporated in any study targeting OEs as a mediator of exercise or collecting exercise data with an accelerometer.

SUBMITTER: Hirschey R

PROVIDER: S-EPMC6684254 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors.

Hirschey Rachel R Kimmick Gretchen G Hockenberry Marilyn M Shaw Ryan R Pan Wei W Page Christina C Lipkus Isaac I

Psycho-oncology 20180911 10

<h4>Objective</h4>The objective of the study is to test theoretical intervention fidelity and feasibility of MOVING ON, a self-directed, home-based, randomized controlled trial to increase exercise outcome expectations (OEs) (what one expects to obtain or avoid as a result of a behavior or lack thereof), among breast cancer survivors.<h4>Method</h4>Stage Ia to IIb survivors (n = 60) were given the MOVING ON intervention or control booklet. Data were collected through online surveys and an accele ...[more]

PMID: 30071146

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Project description:BackgroundObservational data support inverse relationships between exercise or metformin use and disease outcomes in colorectal and breast cancer survivors, although the mechanisms underlying these associations are not well understood.MethodsIn a phase II trial, stage I-III colorectal and breast cancer survivors who completed standard therapy were randomly assigned to structured exercise or metformin or both or neither for 12 weeks. The primary outcome was change in fasting insulin levels; secondary outcomes included changes in other blood-based energetic biomarkers and anthropometric measurements. Analyses used linear mixed models.ResultsIn total, 139 patients were randomly assigned; 91 (65%) completed follow-up assessments. Fasting insulin levels statistically significantly decreased in all three intervention arms (-2.47 μU/mL combination arm, -0.08 μU/mL exercise only, -1.16 μU/mL metformin only, + 2.79 μU/mL control arm). Compared with the control arm, all groups experienced statistically significant weight loss between baseline and 12 weeks (-1.8% combination arm, -0.22% exercise only, -1.0% metformin only, +1.55% control). The combination arm also experienced statistically significant improvements in the homeostatic model assessment for insulin resistance (-30.6% combination arm, +61.2% control) and leptin (-42.2% combination arm, -0.8% control), compared with the control arm. The interventions did not change insulin-like growth factor-1 or insulin-like growth factor binding protein-3 measurements as compared with the control arm. Tolerance to metformin limited compliance (approximately 50% of the participants took at least 75% of the planned dosages in both treatment arms).ConclusionsThe combination of exercise and metformin statistically significantly improved insulin and associated metabolic markers, as compared to the control arm, with potential greater effect than either exercise or metformin alone though power limited formal synergy testing. Larger efforts are warranted to determine if such a combined modality intervention can improve outcomes in colorectal and breast cancer survivors.

Project description:IntroductionChronic pain is a common symptom significantly affecting the quality of life of breast cancer survivors. Despite the achievement of pharmacological interventions, the barriers associated with this approach such as inaccessibility, misuse and side effects drive research into effective non-pharmacological interventions to improve chronic pain management, quality of life, anxiety and depression. Breathing exercise (BE) can be a promising option, but research evidence is sparse. This pilot study aims to examine the feasibility and preliminary effect of using an evidence-based BE intervention for chronic pain management in breast cancer survivors.Method and analysisThis study will be a two-parallel-arm, open-labelled, phase II randomised controlled trial with 1:1 allocation. Seventy-two participants will be recruited from a tertiary hospital in China and randomly allocated to either a BE intervention group (n=36) or a control group (n=36). The participants in the intervention group will receive the usual care, a pain information booklet and a 4-week self-administered BE intervention; the participants in the control group will receive the usual care and the pain information booklet only. The assessment will be conducted at three time points: baseline (week 0), immediately after the intervention completion (week 5) and 4 weeks after the intervention completion (week 9). The primary outcomes will be the acceptability and feasibility assessment of the study protocol and methodological procedures. The secondary outcomes will be the effects of BE on pain, quality of life, anxiety and depression in breast cancer survivors. Descriptive statistics will be applied to present the primary outcomes and the Generalised Estimating Equation Model will be utilised to analyse the clinical outcomes.Ethics and disseminationThis study has received ethical approvals from the Human Research Ethics Committee at Charles Darwin University (H21089) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Southwest Medical University (KY2022107). Findings from this study will be presented at academic conferences and submitted to peer-reviewed journals for publication.Trial registration numberClinicalTrials.gov: NCT05257876.

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A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors.

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A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors.

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