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

NCT ID: NCT03524716

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2020-08-21

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.

Conditions

Colorectal Cancer; Colon Cancer; Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fitbit and Text Messages

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

Group Type: EXPERIMENTAL

Fitbit and Text Messages

Intervention Type: BEHAVIORAL

Physical activity tracker wristband and daily text messages delivered to the participants' phones.

Usual Care

Participants randomized to usual care receive print materials at baseline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fitbit and Text Messages

Physical activity tracker wristband and daily text messages delivered to the participants' phones.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin L Van Blarigan, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35014958 (View on PubMed)

Other Identifiers

NCI-2018-00621

Identifier Type: REGISTRY

Identifier Source: secondary_id

174525

Identifier Type: -

Identifier Source: org_study_id