Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Erin L Van Blarigan

Description

Summary

There is a critical need for physical activity interventions in 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

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

Keywords

Colorectal Cancer Colon Cancer Rectal Cancer physical activity digital health text messages intervention exercise randomized Fitbit Colorectal Neoplasms Fitbit and Text Messages

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • ECOG performance status 0-1

You CAN'T join if...

  • 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 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)
  • Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
  • Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity
  • Chest pain brought on by physical activity
  • Developed chest pain in the past month

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03524716
Study Type
Interventional
Last Updated