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 |
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.
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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