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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer
• Interventions: Behavioral: Fitbit and Text Messages

• Registration Number: NCT03524716
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-15
• Status Verified: 2020-08
• Primary Completion: 2020-08-21
• Study Completion: 2020-08-21
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fitbit and Text Messages	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Objective physical activity	At 0 weeks and 12 weeks from study start	Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
Fatigue	At 0 and 12 weeks from study start	Lee Fatigue Scale
Cardiorespiratory fitness	At 0 and 12 weeks from study start	6 minute walk test
Anthropometrics, Waist circumference	At 0 and 12 weeks from study start
Anthropometrics, Body weight	At 0 and 12 weeks from study start
Sleep quality	At 0 and 12 weeks from study start	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.
Health-related quality of life in cancer patients	At 0 and 12 weeks from study start	Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30
Health-related quality of life in colorectal cancer patients	At 0 and 12 weeks from study start	Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29
Neuropathy	At 0 and 12 weeks from study start	Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
Anxiety	At 0 and 12 weeks from study start	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.
Depression	At 0 and 12 weeks from study start	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.
Leisure-time physical activity	At 0 and 12 weeks from study start	Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
Perceived barriers to physical activity	At 0 and 12 weeks from study start	Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.
Exercise Confidence	At 0 and 12 weeks from study start	Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
Social support	At 0 and 12 weeks from study start	Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States