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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Colon Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Behavioral: Fitbit and Text Messages

Study type: Interventional

Funder types: Other

Identifiers

NCT03524716

NCI-2018-00621 (Registry Identifier)

174525

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Fitbit and Text Messages

Experimental group

Description:

Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.

Treatment:

Behavioral: Fitbit and Text Messages

Usual Care

No Intervention group

Description:

Participants randomized to usual care receive print materials at baseline.