- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02969291
A Home-Based Study to Enhance Activity in Breast Cancer Survivors
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:
- To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
- Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
- Assess cost of the intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Springfield, Massachusetts, États-Unis, 01109
- Baystate Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Reduced Sedentary Time Intervention
Reduced Sedentary Time Intervention (RSTI)
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sedentary Time
Délai: 8 weeks
|
Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
|
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Activity Level
Délai: 8 weeks
|
Change in Activity level as recorded by Actigraph monitor in all 25 participants
|
8 weeks
|
|
Glucose
Délai: 8 weeks
|
Change in fasting glucose ( mmol/L)in all 25 participants
|
8 weeks
|
|
Insulin
Délai: 8 weeks
|
Change in insulin (pmol/L) in all 25 participants
|
8 weeks
|
|
Total cholesterol
Délai: 8 weeks
|
Change in total cholesterol (mmol) in all 25 participants
|
8 weeks
|
|
High density lipoprotien cholesterol
Délai: 8 weeks
|
Change in high density lipoprotein cholesterol (mmol) in all 25 participants
|
8 weeks
|
|
Triglyceride
Délai: 8 weeks
|
Change in triglycerides (mmol) in all 25 participants
|
8 weeks
|
|
Body Mass Index
Délai: 8 weeks
|
Change in Body Mass Index (kg/m2) in all 25 participants
|
8 weeks
|
|
Waist Circumference
Délai: 8 weeks
|
Change in waist circumference in cm in all 25 participants
|
8 weeks
|
|
Systolic Blood pressure
Délai: 8 weeks
|
Change in systolic blood pressure measured in mmHg in all 25 participants
|
8 weeks
|
|
Diastolic Blood pressure
Délai: 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
Délai: 8 weeks
|
8 weeks
|
|
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Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
Délai: 8 weeks
|
8 weeks
|
|
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Sedentary behavior self -efficacy
Délai: 8 weeks
|
Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants
|
8 weeks
|
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Change in EORTC-QLQ-C30 scores in all 25 participants
Délai: 8 weeks
|
8 weeks
|
|
|
Assessment of Intervention
Délai: 8 weeks
|
Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants
|
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Grace Makari-Judson, MD, Baystate Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 776553-5
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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