- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02348710
Exercise Intervention for Cancer Survivors
26. Januar 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
64
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
North Carolina
-
Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University School of Nursing
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
19 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Aktiver 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.
|
The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
change in OE importance, as measured by questionnaire
Zeitfenster: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in OE accessibility, as measured by questionnaire
Zeitfenster: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in OE certainty, as measured by questionnaire
Zeitfenster: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
change in intentions to exercise, as measured by questionnaire
Zeitfenster: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in total weekly minutes of exercise
Zeitfenster: baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2015
Primärer Abschluss (Tatsächlich)
1. September 2016
Studienabschluss (Tatsächlich)
1. September 2016
Studienanmeldedaten
Zuerst eingereicht
23. Januar 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. Januar 2015
Zuerst gepostet (Schätzen)
28. Januar 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
27. Januar 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Januar 2017
Zuletzt verifiziert
1. August 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- Pro00059469
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .