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A Home-Based Study to Enhance Activity in Breast Cancer Survivors

16 luglio 2019 aggiornato da: Baystate Medical Center

There is a well-documented association between physical activity & risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role.

This study has three goals:

  1. To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
  2. Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
  3. Assess cost of the intervention.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

There is a well-documented association between physical activity and risk for breast cancer development and recurrence. Exercise training interventions have been effective at increasing physical activity levels in breast cancer survivors, however they require 1) a large degree of patient initiative to achieve positive health outcomes associated with sustained behavioral change and 2) facilities and oversight that may be prohibitive in a clinical setting. Although most activity-based research to date has focused on increasing levels of moderate to vigorous physical activity (MVPA) for breast cancer survivors, large epidemiological studies suggest that breast cancer survivors are also more sedentary when compared to non-cancer controls. A recent meta-analysis of controlled intervention trials designed to promote physical activity among sedentary cancer survivors found that none of the trials within the scope of the review succeeded in achieving 75% or better adherence to prescribed exercise guidelines, leading the authors to question whether shifting the target of intervention from MVPA to reductions in sedentary time might be a more realistic goal. Recent research suggests that interventions designed to reduce sedentary time in breast cancer survivors have the potential to yield clinically meaningful health benefits, especially for individuals at higher risk for sedentary behaviors, however the optimal method of intervention is not clear.

Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to reduce sedentary behavior in breast cancer survivors. The behavioral intervention will involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity patterns, combined with tailored activity prompts described over the following 6 weeks.

Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of the intervention on levels of sedentary behavior, physical activity and symptoms of cancer survivorship (e.g. cancer related fatigue).

Aim 2b: Evaluate the relationship between change in sedentary behavior and change in cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1, Leptin), following the reduced sedentary time intervention.

Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of the intervention and its individual components, dose delivered and dose received by intervention participants Aim 3b: Quantitatively describe intervention participants' perspectives on the impact of the individual intervention components, including which components appeared most useful for reducing sedentary time.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

13

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti, 01109
        • Baystate Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Stage I-III breast cancer survivors 20-80 who have completed primary treatment (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years ago. Patients may be on adjuvant hormonal therapy
  • BMI > 25 (overweight or class I/II obese)
  • Not meeting current guidelines for regular exercise as defined by less than 150 minutes a week of moderate to vigorous physical activity
  • No gain or loss of >10% body weight over the prior 6 months.

Exclusion Criteria:

  • Known diabetes
  • Known coronary artery disease
  • Pregnancy
  • Any injury that would limit mobility or require use of assisted mobility devices
  • Weight gain or loss of >10% body weight over the prior 6 months
  • Greater than 150 minutes a week of moderate to vigorous physical activity
  • Inability to provide informed consent
  • Non-english speaking

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Reduced Sedentary Time Intervention
Reduced Sedentary Time Intervention (RSTI)
Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sedentary Time
Lasso di tempo: 8 weeks
Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Activity Level
Lasso di tempo: 8 weeks
Change in Activity level as recorded by Actigraph monitor in all 25 participants
8 weeks
Glucose
Lasso di tempo: 8 weeks
Change in fasting glucose ( mmol/L)in all 25 participants
8 weeks
Insulin
Lasso di tempo: 8 weeks
Change in insulin (pmol/L) in all 25 participants
8 weeks
Total cholesterol
Lasso di tempo: 8 weeks
Change in total cholesterol (mmol) in all 25 participants
8 weeks
High density lipoprotien cholesterol
Lasso di tempo: 8 weeks
Change in high density lipoprotein cholesterol (mmol) in all 25 participants
8 weeks
Triglyceride
Lasso di tempo: 8 weeks
Change in triglycerides (mmol) in all 25 participants
8 weeks
Body Mass Index
Lasso di tempo: 8 weeks
Change in Body Mass Index (kg/m2) in all 25 participants
8 weeks
Waist Circumference
Lasso di tempo: 8 weeks
Change in waist circumference in cm in all 25 participants
8 weeks
Systolic Blood pressure
Lasso di tempo: 8 weeks
Change in systolic blood pressure measured in mmHg in all 25 participants
8 weeks
Diastolic Blood pressure
Lasso di tempo: 8 weeks
Change in diastolic blood pressure measured in mmHg in all 25 participants
8 weeks
Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants
Lasso di tempo: 8 weeks
8 weeks
Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
Lasso di tempo: 8 weeks
8 weeks
Sedentary behavior self -efficacy
Lasso di tempo: 8 weeks
Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants
8 weeks
Change in EORTC-QLQ-C30 scores in all 25 participants
Lasso di tempo: 8 weeks
8 weeks
Assessment of Intervention
Lasso di tempo: 8 weeks
Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants
8 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Grace Makari-Judson, MD, Baystate Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2016

Completamento primario (Effettivo)

1 ottobre 2018

Completamento dello studio (Effettivo)

1 ottobre 2018

Date di iscrizione allo studio

Primo inviato

2 novembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

17 novembre 2016

Primo Inserito (Stima)

21 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 776553-5

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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