This randomized pilot clinical trial studies how well survivorship care plan works in promoting technology-based physical activity in breast or colorectal cancer survivors in Wisconsin. A survivorship care plan may help doctors to better understand how they can help people who have been diagnosed with cancer to become more physically active. It is not yet known whether a standardized cancer survivor plan used as part of routine care or a technology-based physical activity intervention is better in promoting physical activity in breast or colorectal cancer survivors.
PRIMARY OBJECTIVES: I. Establish the feasibility of enrolling breast and colorectal cancer survivors along with a co-survivor into a randomized physical activity promotion trial. II. Determine the short-term effect of an enhanced survivorship care plan (SCP) compared to the standard SCP on objectively-measured physical activity among survivors and co-survivors. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (Enhanced SCP): Participants receive an enhanced SCP, comprised of a personalized document that summarizes treatment and follow up recommendations, including basic physical activity guidance. Participants also receive a copy of the United States Department of Agriculture (USDA) Dietary Guidelines for Americans, as well as standardized emails with wellness tips and information on stress management provided from the American Heart Association's website on "Healthy Habits" at 1, 2, 4, and 8 weeks. Specific topics in emails include "positive self-talk", "daily relaxation breathing techniques", "better sleep", and "ways to find pleasure". Participants also wear a Fitbit web-integrated physical activity tracker daily for 12 weeks and receive email feedback specific to each participant based on a series of factors, including their Fitbit data, Emails may provide encouragement, such as "keep up the good work", and/or very specific instructions regarding compliance with the intervention, goals for meeting physical activity goals, potential strategies to increase/maintain levels of physical activity, etc., and technical or how-to support including how to use the device and website, or questions about goal-setting. ARM II (Control): Participants receive a standard SCP, comprised of a personalized document that summarizes treatment and follow up recommendations, including basic physical activity guidance. Participants also receive a copy of the USDA Dietary Guidelines for Americans, as well as standardized emails with wellness tips and information on stress management provided from the American Heart Association's website on "Healthy Habits" at 1, 2, 4, and 8 weeks. Specific topics in emails include "positive self-talk", "daily relaxation breathing techniques", "better sleep", and "ways to find pleasure".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Receive educational material regarding physical activity and standardized emails with wellness tips and information on stress management
Receive email and technical or how-to support from study coordinator
Wear a Fitbit web-integrated physical activity tracker
Ancillary studies
Ancillary studies
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Feasibility as defined by recruitment rate
Measures include recruitment rate (ability to recruit ≥5 patients per month to the study), retention rate (ability to collect all measures on ≥80% of randomized patients) and patient satisfaction with SCP, Fitbit, and physical activity intervention materials, both overall and by cancer type (breast/colon).
Time frame: Up to 12 weeks
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm I)
ActiGraph accelerometer will be compared between the arms (intervention and control) using a mixed effects model for repeated daily measures at week 0 (baseline) and week 12. Explanatory factors will be study week, measurement day and the randomization group by week interaction (the primary parameter of interest).
Time frame: Up to 12 weeks
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm II)
ActiGraph GT3X+ accelerometer will be compared between the arms (intervention and control) using a mixed effects model for repeated daily measures at week 0 (baseline) and week 12. Explanatory factors will be study week, measurement day and the randomization group by week interaction (the primary parameter of interest).
Time frame: Up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.