Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (SmartPaceII)

Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)

There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Fitbit and Text Messages

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

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:

• Diagnosed with colon or rectal adenocarcinoma
• Expected to receive at least 12 weeks of chemotherapy
• Able to speak and read English
• Access to a mobile phone with Internet and text messaging capabilities
• ≥4 weeks since last major surgery and fully recovered
• ≥18 years old
• Physician consent to participate in unsupervised moderate intensity physical activity
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

• Engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination
• Hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy
• Any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced Chronic Obstructive Pulmonary Disease (COPD) on oxygen
• Serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI)
• Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitbit and Text Messages; Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.	Behavioral: Fitbit and Text Messages; Physical activity tracker wristband and daily text messages delivered to the participants' phones.
No Intervention: Usual Care; Participants randomized to usual care receive print materials at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitbit wear time	Number of study days Fitbit is worn	up to 12 weeks from study start
Acceptability of the intervention	Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.	At 12 weeks from study start
Text message response rate		up to 12 weeks from study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective physical activity	Minutes of moderate-to-vigorous physical activity per week measured by accelerometer	At 0 weeks and 12 weeks from study start
Fatigue	Lee Fatigue Scale	At 0 and 12 weeks from study start
Cardiorespiratory fitness	6 minute walk test	At 0 and 12 weeks from study start
Anthropometrics, Waist circumference		At 0 and 12 weeks from study start
Anthropometrics, Body weight		At 0 and 12 weeks from study start
Sleep quality	Will be assessed by the Pittsburgh Sleep Quality Index, providing a score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	At 0 and 12 weeks from study start
Health-related quality of life in cancer patients	Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30	At 0 and 12 weeks from study start
Health-related quality of life in colorectal cancer patients	Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29	At 0 and 12 weeks from study start
Neuropathy	Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.	At 0 and 12 weeks from study start
Anxiety	Will be assessed by the Spielberger State-Trait Anxiety Inventories (STAI), consisting of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.	At 0 and 12 weeks from study start
Depression	Will be assessed by the Center for Epidemiological Studies-Depression Scale (CES-D), a brief self-report questionnaire which consists of 20 questions. Scores on the CES-D range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms.	At 0 and 12 weeks from study start
Leisure-time physical activity	Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.	At 0 and 12 weeks from study start
Perceived barriers to physical activity	Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.	At 0 and 12 weeks from study start
Exercise Confidence	Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.	At 0 and 12 weeks from study start
Social support	Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.	At 0 and 12 weeks from study start

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Erin L Van Blarigan, ScD, University of California, San Francisco

Publications and helpful links

General Publications

• Van Blarigan EL, Dhruva A, Atreya CE, Kenfield SA, Chan JM, Milloy A, Kim I, Steiding P, Laffan A, Zhang L, Piawah S, Fukuoka Y, Miaskowski C, Hecht FM, Kim MO, Venook AP, Van Loon K. Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). JMIR Cancer. 2022 Jan 11;8(1):e31576. doi: 10.2196/31576.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): August 21, 2020
• Study Completion (Actual): August 21, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; exercise; intervention; digital health; text messages; randomized; Fitbit
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 174525; NCI-2018-00621 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No