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

NCT03524716 | Completed

• 2 other identifiers: 174525NCI-2018-00621
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

physical activity; digital health; text messages; intervention; exercise; randomized; Fitbit

Outcome Measures

Primary Outcomes (3)

• Fitbit wear time

  Number of study days Fitbit is worn

  up to 12 weeks from study start

• Acceptability of the intervention

  Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.

  At 12 weeks from study start

• Text message response rate

  up to 12 weeks from study start

Secondary Outcomes (15)

• Objective physical activity

  At 0 weeks and 12 weeks from study start

• Fatigue

  At 0 and 12 weeks from study start

• Cardiorespiratory fitness

  At 0 and 12 weeks from study start

• Anthropometrics, Waist circumference

  At 0 and 12 weeks from study start

• Anthropometrics, Body weight

  At 0 and 12 weeks from study start

Study Arms (2)

Fitbit and Text Messages

EXPERIMENTAL

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

Behavioral: Fitbit and Text Messages

Usual Care

NO INTERVENTION

Participants randomized to usual care receive print materials at baseline.

Interventions

Fitbit and Text Messages BEHAVIORAL

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

Fitbit and Text Messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 35014958 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Officials

• Erin L Van Blarigan, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: May 15, 2018
• Study Start: March 6, 2018
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)