Exercise Intervention for Cancer Survivors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - 90
Updated:8/3/2016
Start Date:June 2015
End Date:April 2017
Contact:Rachel Hirschey, PhDc
Email:rachel.hirschey@duke.edu
Phone:9196139710

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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.

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.

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:
We found this trial at
1
site
Durham, North Carolina 27710
Phone: 919-613-9710
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Durham, NC
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