- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02348710
Exercise Intervention for Cancer Survivors
26 gennaio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
64
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
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University School of Nursing
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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 19 anni a 90 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
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: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
|
|
Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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change in OE importance, as measured by questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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change in intentions to exercise, as measured by questionnaire
Lasso di tempo: 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
Lasso di tempo: baseline 4- 8- and 12-weeks post intervention
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baseline 4- 8- and 12-weeks post intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Effettivo)
1 giugno 2015
Completamento primario (Effettivo)
1 settembre 2016
Completamento dello studio (Effettivo)
1 settembre 2016
Date di iscrizione allo studio
Primo inviato
23 gennaio 2015
Primo inviato che soddisfa i criteri di controllo qualità
23 gennaio 2015
Primo Inserito (Stima)
28 gennaio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 gennaio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 gennaio 2017
Ultimo verificato
1 agosto 2016
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Pro00059469
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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