- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02348710
Exercise Intervention for Cancer Survivors
26 stycznia 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
64
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University School of Nursing
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
19 lat do 90 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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
|
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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
change in OE importance, as measured by questionnaire
Ramy czasowe: 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
Ramy czasowe: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in OE certainty, as measured by questionnaire
Ramy czasowe: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
change in intentions to exercise, as measured by questionnaire
Ramy czasowe: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
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change in total weekly minutes of exercise
Ramy czasowe: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 czerwca 2015
Zakończenie podstawowe (Rzeczywisty)
1 września 2016
Ukończenie studiów (Rzeczywisty)
1 września 2016
Daty rejestracji na studia
Pierwszy przesłany
23 stycznia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 stycznia 2015
Pierwszy wysłany (Oszacować)
28 stycznia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
27 stycznia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 stycznia 2017
Ostatnia weryfikacja
1 sierpnia 2016
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Pro00059469
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .