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

NCT ID: NCT02677389

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2018-01-24

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".

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (Enhanced SCP)

See Detailed Description

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

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

Internet-Based Intervention

Intervention Type: OTHER

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

Monitoring Device

Intervention Type: DEVICE

Wear a Fitbit web-integrated physical activity tracker

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (SCP)

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".

Group Type: ACTIVE_COMPARATOR

Educational Intervention

Intervention Type: OTHER

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

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Educational Intervention

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

Intervention Type: OTHER

Internet-Based Intervention

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

Intervention Type: OTHER

Monitoring Device

Wear a Fitbit web-integrated physical activity tracker

Intervention Type: DEVICE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Education for Intervention; Intervention, Educational; Monitor; Fitbit; Quality of Life Assessment

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

• 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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Cadmus-Bertram

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32808383 (View on PubMed)

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

NCI-2016-00111

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-1295

Identifier Type: OTHER

Identifier Source: secondary_id

A176000

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC\KINESIOLOGY\KINESIO

Identifier Type: OTHER

Identifier Source: secondary_id

UW15059

Identifier Type: -

Identifier Source: org_study_id