Clinical trial NCT03524716: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II
Official title: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Keywords: physical activity
digital health
text messages
intervention
exercise
randomized
Fitbit
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fitbit wear time
timeFrame: up to 12 weeks from study start
measure: Acceptability of the intervention
timeFrame: At 12 weeks from study start
measure: Text message response rate
timeFrame: up to 12 weeks from study start
Secondary outcomes:
measure: Objective physical activity
timeFrame: At 0 weeks and 12 weeks from study start
measure: Fatigue
timeFrame: At 0 and 12 weeks from study start
measure: Cardiorespiratory fitness
timeFrame: At 0 and 12 weeks from study start
measure: Anthropometrics, Waist circumference
timeFrame: At 0 and 12 weeks from study start
measure: Anthropometrics, Body weight
timeFrame: At 0 and 12 weeks from study start
measure: Sleep quality
timeFrame: At 0 and 12 weeks from study start
measure: Health-related quality of life in cancer patients
timeFrame: At 0 and 12 weeks from study start
measure: Health-related quality of life in colorectal cancer patients
timeFrame: At 0 and 12 weeks from study start
measure: Neuropathy
timeFrame: At 0 and 12 weeks from study start
measure: Anxiety
timeFrame: At 0 and 12 weeks from study start
measure: Depression
timeFrame: At 0 and 12 weeks from study start
measure: Leisure-time physical activity
timeFrame: At 0 and 12 weeks from study start
measure: Perceived barriers to physical activity
timeFrame: At 0 and 12 weeks from study start
measure: Exercise Confidence
timeFrame: At 0 and 12 weeks from study start
measure: Social support
timeFrame: At 0 and 12 weeks from study start
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Erin L Van Blarigan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Blarigan EL, Dhruva A, Atreya CE, Kenfield SA, Chan JM, Milloy A, Kim I, Steiding P, Laffan A, Zhang L, Piawah S, Fukuoka Y, Miaskowski C, Hecht FM, Kim MO, Venook AP, Van Loon K. Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). JMIR Cancer. 2022 Jan 11;8(1):e31576. doi: 10.2196/31576.