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

NCT02677389 | Completed DMC

• 5 other identifiers: UW15059NCI-2016-001112015-1295A176000EDUC\KINESIOLOGY\KINESIO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 weeks

Secondary Outcomes (2)

• Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm I)

  Up to 12 weeks

• Physical activity as measured by the ActiGraph GT3X+ accelerometer (Arm II)

  Up to 12 weeks

Study Arms (2)

Arm I (Enhanced SCP)

EXPERIMENTAL

See Detailed Description

Other: Educational Intervention; Other: Internet-Based Intervention; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (SCP)

ACTIVE COMPARATOR

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".

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

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

Also known as: Education for Intervention, Intervention, Educational

Arm I (Enhanced SCP); Arm II (SCP)

Internet-Based Intervention OTHER

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

Arm I (Enhanced SCP)

Monitoring Device DEVICE

Wear a Fitbit web-integrated physical activity tracker

Also known as: Monitor, Fitbit

Arm I (Enhanced SCP)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Enhanced SCP); Arm II (SCP)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Enhanced SCP); Arm II (SCP)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 32808383 DERIVED

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lisa Cadmus-Bertram

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 9, 2016
• Study Start: July 1, 2016
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-02

Locations

US (1)