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Exercise Intervention for Cancer Survivors

26. ledna 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

64

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • North Carolina
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University School of Nursing

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

19 let až 90 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  1. stage 1A - 2B breast cancer diagnosis;
  2. 2 months - 10 years status post surgery, radiation and chemotherapy;
  3. inactive (self-reported ≤ 150 min/wk moderate - strenuous-intensity exercise);
  4. no evidence of cancer recurrence;
  5. 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);
  6. English-speaking and writing;
  7. access and ability to use a computer for completion of online measures; and
  8. possession of smartphone

Exclusion Criteria:

None

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Aktivní komparátor: 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.
The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
change in OE importance, as measured by questionnaire
Časové okno: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in OE accessibility, as measured by questionnaire
Časové okno: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in OE certainty, as measured by questionnaire
Časové okno: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention

Sekundární výstupní opatření

Měření výsledku
Časové okno
change in intentions to exercise, as measured by questionnaire
Časové okno: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in total weekly minutes of exercise
Časové okno: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2015

Primární dokončení (Aktuální)

1. září 2016

Dokončení studie (Aktuální)

1. září 2016

Termíny zápisu do studia

První předloženo

23. ledna 2015

První předloženo, které splnilo kritéria kontroly kvality

23. ledna 2015

První zveřejněno (Odhad)

28. ledna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. ledna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. ledna 2017

Naposledy ověřeno

1. srpna 2016

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • Pro00059469

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Klinické studie na Exercise OE workbook

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