- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02348710
Exercise Intervention for Cancer Survivors
26 janvier 2017 mis à jour par: Duke University
Exercise Outcome Expectations Among Breast Cancer Survivors
This randomized controlled trial will test a multicomponent intervention to increase exercise Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels of exercise.
Sixty early stage breast cancer survivors will be recruited from the Duke Cancer Institute.
Participants will be randomized to the exercise OE intervention or an attention control group.
Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer.
The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of).
The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This study will test a theory-based intervention to increase levels of exercise among breast cancer survivors, in order to help them self-manage their long-term treatment side effects.
The study focuses on outcome expectations (OEs), a significant yet understudied construct that is central to most behavior change theories.
OEs refer to what people expect to obtain or avoid by engaging in a behavior; thus, people exercise because they believe it will produce desired outcomes.
This randomized controlled trial will test a multicomponent intervention to increase exercise OEs and assess effects of OE changes on exercise intentions and levels of exercise.
Sixty early stage (IA to IIB) inactive breast cancer survivors will be recruited from the Duke Cancer Institute.
Participants will be randomized to the exercise OE intervention or an attention control group.
Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer.
The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of).
The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.
OE importance, OE certainty, OE accessibility, exercise intentions, exercise, and self-efficacy (a potential co-variate) will be assessed through online surveys at baseline, 4-, 8-, and 12-weeks post-intervention.
At each time point, accelerometer data will be collected as an objective exercise measure.
Specific aims of the study are to: (1) examine trajectories of OE importance, certainty and accessibility between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4-, 8- and 12-weeks post-intervention; and (2) examine trajectories of exercise intentions and total weekly minutes of exercise, between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4, 8 and 12 weeks post-intervention.
If the intervention increases exercise among breast cancer survivors it may lead to improved survivorship duration and quality of life.
The intervention can be implemented readily in clinic settings to support survivors to exercise more and thus experience better long-term outcomes.
This study also provides a foundation for a developing a nurse scientist's program of research focused on designing theory-based exercise interventions for chronically ill populations.
Type d'étude
Interventionnel
Inscription (Réel)
64
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University School of Nursing
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
19 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- stage 1A - 2B breast cancer diagnosis;
- 2 months - 10 years status post surgery, radiation and chemotherapy;
- inactive (self-reported ≤ 150 min/wk moderate - strenuous-intensity exercise);
- no evidence of cancer recurrence;
- no pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program (e.g., severe orthopedic conditions, scheduled hip or knee replacement within 6 months, paralysis and/or dementia, unstable angina, history of myocardial infarction, congestive heart failure);
- English-speaking and writing;
- access and ability to use a computer for completion of online measures; and
- possession of smartphone
Exclusion Criteria:
None
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: exercise outcome expectation workbook
Intervention arm participants will receive: 1) the ACS exercise and diet guidelines; and 2) an exercise outcome expectation workbook.
The workbook contains self-directed activities to increase OE importance, certainty, and accessibility.
The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many positive exercise outcomes breast cancer survivors may experience.
Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist.
Accessibility will be increased by having the participant think about the association between exercise and its outcomes.
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The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many and diverse positive outcomes breast cancer survivors may experience.
Participants will then be asked to focus on the three OEs they would most like to experience.
Each section of the OE guide contains activities to target specific OE dimensions.
Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist.
Accessibility will be increased by having the participant think about the association between exercise and its outcomes
|
|
Comparateur actif: diet workbook
Attention control participants will receive via mail 1) the ACS exercise and diet guidelines; and 2) a diet workbook.
The diet workbook contains the same activities as the exercise outcome expectation workbook but is focused on diet instead of exercise.
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The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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change in OE importance, as measured by questionnaire
Délai: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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change in OE accessibility, as measured by questionnaire
Délai: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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change in OE certainty, as measured by questionnaire
Délai: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
change in intentions to exercise, as measured by questionnaire
Délai: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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change in total weekly minutes of exercise
Délai: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2015
Achèvement primaire (Réel)
1 septembre 2016
Achèvement de l'étude (Réel)
1 septembre 2016
Dates d'inscription aux études
Première soumission
23 janvier 2015
Première soumission répondant aux critères de contrôle qualité
23 janvier 2015
Première publication (Estimation)
28 janvier 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 janvier 2017
Dernière vérification
1 août 2016
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro00059469
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .