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Survivorship Care Plan in Promoting Physical Activity in Breast or Colorectal Cancer Survivors in Wisconsin

Active Living After Cancer: Building a Physical Activity Intervention Into Clinical Care for Breast and Colorectal Cancer Survivors in Wisconsin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02677389
Enrollment
100
Registered
2016-02-09
Start date
2016-07-01
Completion date
2018-01-24
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivor, Healthy Subject, Stage I Colorectal Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIA Colorectal Cancer, Stage IIB Breast Cancer, Stage IIB Colorectal Cancer, Stage IIC Colorectal Cancer, Stage IIIA Breast Cancer, Stage IIIA Colorectal Cancer, Stage IIIB Breast Cancer, Stage IIIB Colorectal Cancer, Stage IIIC Breast Cancer, Stage IIIC Colorectal Cancer

Brief summary

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.

Detailed description

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.

Interventions

OTHEREducational Intervention

Receive educational material regarding physical activity and standardized emails with wellness tips and information on stress management

OTHERInternet-Based Intervention

Receive email and technical or how-to support from study coordinator

Wear a Fitbit web-integrated physical activity tracker

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* CRITERIA FOR SURVIVORS: * Have a diagnosis of stage I-III female breast cancer or colorectal cancer within the past 5 years; bilateral or multiple primary breast cancers are permitted; individuals who have had more than one type of cancer (e.g., both breast and melanoma) are permitted as long as the breast (or colorectal) diagnosis meets the other criteria and primary treatment for any cancer is not ongoing * Have completed primary treatment for their cancer; primary treatment will be defined as having completed all (a) definitive cancer surgery, (b) (neo)adjuvant chemotherapy, and/or (c) (neo)adjuvant radiation; breast cancer patients still receiving adjuvant endocrine or human epidermal growth factor receptor 2 (HER2) targeted therapies are eligible, as would colon cancer patients receiving a targeted agent; if there is any question whether a patient meets this eligibility requirement, Dr. Tevaarwerk (co-I, Oncology) will adjudicate * Are willing to attempt increase in physical activity level * Have a co-survivor (friend or family member) willing to participate in this research study * ELIGIBILITY CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS: * Have high-speed access to the internet at home or work; This could be broadband, digital subscriber line (DSL), and/or access on a smartphone or tablet via a wireless provider * Fluent in English * Willing and able to attend study visits at the University of Wisconsin (UW) - Madison * Co-survivors must be over the age of 18 years

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Feasibility as defined by recruitment rateUp to 12 weeksMeasures 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).

Secondary

MeasureTime frameDescription
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm I)Up to 12 weeksActiGraph 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).
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm II)Up to 12 weeksActiGraph 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026