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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/17/2018
Start Date:March 6, 2018
End Date:February 2020
Contact:Erin L Van Blarigan, ScD
Email:clinicaltrials@ucsf.edu
Phone:877-827-3222

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

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.


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

- 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
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Erin L Van Blarigan, ScD
Phone: 877-827-3222
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San Francisco, CA
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