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

University of California, San Francisco44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Colon Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Fitbit wear time

Number of study days Fitbit is worn

Time frame: 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.

Time frame: At 12 weeks from study start

Text message response rate

Time frame: up to 12 weeks from study start

Secondary Outcomes

Objective physical activity

Minutes of moderate-to-vigorous physical activity per week measured by accelerometer

Time frame: At 0 weeks and 12 weeks from study start

Fatigue

Lee Fatigue Scale