Exercise Intervention for Cancer Survivors
Condition: Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Exercise OE workbook; Diet workbook
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care