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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Behavioral: Fitbit and Text Messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitbit and Text Messages<br>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<br>* Physical activity tracker wristband and daily text messages delivered to the participants' phones.<br>|
| No Intervention: Usual Care<br>Participants randomized to usual care receive print materials at baseline. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, digital health, text messages, intervention, exercise, randomized, Fitbit