Exercise Intervention for Cancer Survivors

Neoplasms Clinical Trial

Official title:

Exercise Outcome Expectations Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348710
• Other study ID #: Pro00059469
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 26, 2017
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Exercise OE workbook
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
• Diet workbook
The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.

Locations

Country	Name	City	State
United States	Duke University School of Nursing	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in OE importance, as measured by questionnaire		baseline 4- 8- and 12-weeks post intervention
Primary	change in OE accessibility, as measured by questionnaire		baseline 4- 8- and 12-weeks post intervention
Primary	change in OE certainty, as measured by questionnaire		baseline 4- 8- and 12-weeks post intervention
Secondary	change in intentions to exercise, as measured by questionnaire		baseline 4- 8- and 12-weeks post intervention
Secondary	change in total weekly minutes of exercise		baseline 4- 8- and 12-weeks post intervention