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

Primary Purpose

Cancer Survivor, Healthy Subject, Stage I Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Internet-Based Intervention
Monitoring Device
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • EXCLUSION CRITERIA SPECIFIC TO SURVIVORS:

    • Survivors must not have evidence of recurrent or metastatic disease
    • Survivors must not have previously received an SCP or are unwilling to receive one
    • Survivors must not be performing >= 100 minute (min)/week of moderate-vigorous physical activity

  • EXCLUSION CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:

    • Conditions that would interfere with the safety of moderate-to-vigorous intensity physical activity; participants will be screened for safety using the validated Physical Activity Readiness Questionnaire (PAR-Q)
    • Any physical or mental health condition that would interfere with full participation in the study, including individuals who are unable to read consent materials or appear to lack the capacity to consent
    • Any individual considered to be that of a "vulnerable group", including pregnant women and prisoners

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (Enhanced SCP)

Arm II (SCP)

Arm Description

See Detailed Description

Participants receive a standard SCP, comprised of a treatment and follow up recommendations, including basic physical activity guidance, 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".

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
February 1, 2016
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02677389
Brief Title
Survivorship Care Plan in Promoting Physical Activity in Breast or Colorectal Cancer Survivors in Wisconsin
Official Title
Active Living After Cancer: Building a Physical Activity Intervention Into Clinical Care for Breast and Colorectal Cancer Survivors in Wisconsin
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Enhanced SCP)
Arm Type
Experimental
Arm Description
See Detailed Description
Arm Title
Arm II (SCP)
Arm Type
Active Comparator
Arm Description
Participants receive a standard SCP, comprised of a treatment and follow up recommendations, including basic physical activity guidance, 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".
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Receive educational material regarding physical activity and standardized emails with wellness tips and information on stress management
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive email and technical or how-to support from study coordinator
Intervention Type
Device
Intervention Name(s)
Monitoring Device
Other Intervention Name(s)
Monitor, Fitbit
Intervention Description
Wear a Fitbit web-integrated physical activity tracker
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility as defined by recruitment rate
Description
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
Secondary Outcome Measure Information:
Title
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm I)
Description
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
Title
Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm II)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: EXCLUSION CRITERIA SPECIFIC TO SURVIVORS: Survivors must not have evidence of recurrent or metastatic disease Survivors must not have previously received an SCP or are unwilling to receive one Survivors must not be performing >= 100 minute (min)/week of moderate-vigorous physical activity EXCLUSION CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS: Conditions that would interfere with the safety of moderate-to-vigorous intensity physical activity; participants will be screened for safety using the validated Physical Activity Readiness Questionnaire (PAR-Q) Any physical or mental health condition that would interfere with full participation in the study, including individuals who are unable to read consent materials or appear to lack the capacity to consent Any individual considered to be that of a "vulnerable group", including pregnant women and prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Cadmus-Bertram
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32808383
Citation
Rastogi S, Tevaarwerk AJ, Sesto M, Van Remortel B, Date P, Gangnon R, Thraen-Borowski K, Cadmus-Bertram L. Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial. Psychooncology. 2020 Nov;29(11):1917-1926. doi: 10.1002/pon.5524. Epub 2020 Oct 4.
Results Reference
derived
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

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

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