Exercise Intervention for Cancer Survivors
- Conditions
- Neoplasms
- Interventions
- Behavioral: Exercise OE workbookBehavioral: Diet workbook
- Registration Number
- NCT02348710
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 64
- 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
None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description exercise outcome expectation workbook Exercise OE 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. diet workbook 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.
- Primary Outcome Measures
Name Time Method change in OE accessibility, as measured by questionnaire baseline 4- 8- and 12-weeks post intervention change in OE importance, as measured by questionnaire baseline 4- 8- and 12-weeks post intervention change in OE certainty, as measured by questionnaire baseline 4- 8- and 12-weeks post intervention
- Secondary Outcome Measures
Name Time Method change in total weekly minutes of exercise baseline 4- 8- and 12-weeks post intervention change in intentions to exercise, as measured by questionnaire baseline 4- 8- and 12-weeks post intervention
Trial Locations
- Locations (1)
Duke University School of Nursing
🇺🇸Durham, North Carolina, United States