ICanSTEP : Increasing Physical Activity With Text Messaging

ICanSTEP: Increasing Physical Activity in Cancer Survivors Through a Text-messaging Exercise Motivation Program

The proposed pilot study will develop and test feasibility and preliminary efficacy of an exercise motivation intervention using a 12-week smartphone-text messaging program tailored to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors and 15 patients actively undergoing cancer treatment.

Study Overview

• Status: Completed
• Conditions: A Diagnosis of Any Hematologic or Solid Malignancy
• Intervention / Treatment: Other: Daily SMS text messaging

Detailed Description

Cancer survivors have substantial residual cardiometabolic risk due to the fact that they are living longer and are exposed to the same lifestyle and environmental factors that have led to the drastic increase in obesity and diabetes in Western societies over the last four decades. In addition, survivors' cardiovascular health is significantly impaired due to cancer treatment. Research has shown that physical activity improves quality of life in cancer survivors, ameliorates treatment-related side effects reduces the risk of cancer recurrence, and extends overall survival. Despite these advantages, most cancer patients are sedentary. The early survivor period is a teachable moment to improve healthy behaviors. Social Cognitive Theory argues that to change exercise behavior, we must increase behavior change self-efficacy of participants (i.e., confidence), increase their outcome expectations that changing their behavior will lead to better health, enhance motivation to exercise, enhance their ability to regulate their behavior (self-regulation), teach them tangible behavior change skills, and help them overcome barriers to behavior change. In this study validated patient-reported outcomes will be performed at baseline and at 12 weeks - FACIT-F to document general cancer symptoms with additional questions on fatigue, the Beck Depression Inventory (BDI-II), and the modified Godin-Leisure Questionnaire as a measure of activity level. The investigators will also perform baseline and 3 month weight / BMI and 6-minute walk testing as a second well-validated objective measure of fitness. At enrollment and at 3 months, patients will be queried as to barriers to behavior change. At 3 months, patients will be asked by 5-point Likert scale how helpful the program was in increasing their physical activity. Six months after enrollment (+/- 4 weeks), level of physical activity and use of Fitbit will be determined.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Eligible participants must be / have

1. age 18 or older,
2. a diagnosis of any hematologic or solid malignancy
3. a life expectancy of at least 12 months
4. ECOG < /=2
5. in active cancer treatment or have completed active cancer treatment within one year of obtaining consent (with the exception of adjuvant hormonal therapy),
6. not scheduled for any major surgery during the anticipated study period,
7. able to read and understand English
8. sedentary defined as participating in 2 or less days of dedicated physical activity per week,
9. consistent daily access to a smartphone
10. a text messaging plan that includes a minimum of 150 text messages a month at no additional cost
11. capable of providing informed consent.

Exclusion Criteria:

1. Significant cardiac disease (i.e., left ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
2. Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases
3. ECOG >2
4. Participates in 3 or more days of dedicated physical activity per week
5. Known allergic reaction to nickel
6. No access to a smart phone or text messaging plan less than 150 messages per month
7. Physical or psychological contraindication to participation at the discretion of the treating physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1; Cohort 1 will include 15 sedentary participants who have completed all cancer therapy except adjuvant hormonal therapy. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity level for 12 weeks..	Other: Daily SMS text messaging
Active Comparator: Cohort 2; Cohort 2 will include 15 sedentary participants in active treatment. All participants will be provided a Fitbit. Participants will then be provided daily SMS text messaging tailored to their activity levels for 12 weeks.	Other: Daily SMS text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility, as measured by the percentage of eligible patients who can be enrolled	6 months
Feasibility, as measured by accrual rate	6 months
Change in daily step count, as measured by Fitbit	Baseline, 12 weeks
Change in minutes of weekly exercise, as measured by Fitbit	Baseline, 12 weeks
Change in fatigue, as measured by questionnaire	Baseline, 12 weeks
Change in depression, as measured by questionnaire	Baseline, 12 weeks
Change in general activity, as measured by questionnaire	Baseline, 6 months
Change in quality of life, as measured by questionnaire	Baseline, 12 weeks
Change in body mass index (BMI)	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference in daily step count, as measured by Fitbit	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in minutes of weekly exercise, as measured by Fitbit	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in fatigue, as measured by questionnaire	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in depression, as measured by questionnaire	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in general activity, as measured by questionnaire	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in quality of life, as measured by questionnaire	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks
Mean difference in body mass index (BMI)	This will be addressed by calculating the mean difference (with 80% confidence interval) between the two treatment cohorts in change across time.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Bridget Koontz, MD, Duke University

Publications and helpful links

General Publications

• Koontz BF, Levine E, McSherry F, Niedzwiecki D, Sutton L, Dale T, Streicher M, Rushing C, Owen L, Kraus WE, Bennett G, Pollak KI. Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Support Care Cancer. 2021 Dec;29(12):7339-7349. doi: 10.1007/s00520-021-06281-y. Epub 2021 May 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2016
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease
• Other Study ID Numbers: Pro00068978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No