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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524716
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE May 15, 2018
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE March 6, 2018
Actual Primary Completion Date August 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Fitbit wear time [ Time Frame: up to 12 weeks from study start ]
    Number of study days Fitbit is worn
  • Acceptability of the intervention [ Time Frame: At 12 weeks from study start ]
    Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.
  • Text message response rate [ Time Frame: up to 12 weeks from study start ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Objective physical activity [ Time Frame: At 0 weeks and 12 weeks from study start ]
    Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
  • Fatigue [ Time Frame: At 0 and 12 weeks from study start ]
    Lee Fatigue Scale
  • Cardiorespiratory fitness [ Time Frame: At 0 and 12 weeks from study start ]
    6 minute walk test
  • Anthropometrics, Waist circumference [ Time Frame: At 0 and 12 weeks from study start ]
  • Anthropometrics, Body weight [ Time Frame: At 0 and 12 weeks from study start ]
  • Sleep quality [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Pittsburgh Sleep Quality Index, providing a score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
  • Health-related quality of life in cancer patients [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30
  • Health-related quality of life in colorectal cancer patients [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29
  • Neuropathy [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
  • Anxiety [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Spielberger State-Trait Anxiety Inventories (STAI), consisting of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
  • Depression [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Center for Epidemiological Studies-Depression Scale (CES-D), a brief self-report questionnaire which consists of 20 questions. Scores on the CES-D range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms.
  • Leisure-time physical activity [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
  • Perceived barriers to physical activity [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.
  • Exercise Confidence [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
  • Social support [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Objective physical activity [ Time Frame: At 0 weeks and 12 weeks from study start ]
    Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
  • Fatigue [ Time Frame: At 0 and 12 weeks from study start ]
    Lee Fatigue Scale
  • Cardiorespiratory fitness [ Time Frame: At 0 and 12 weeks from study start ]
    6 minute walk test
  • Anthropometrics, Waist circumference [ Time Frame: At 0 and 12 weeks from study start ]
  • Anthropometrics, Body weight [ Time Frame: At 0 and 12 weeks from study start ]
  • Sleep quality [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Pittsburgh Sleep Quality Index, providing a score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
  • Health-related quality of life in cancer patients [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30
  • Health-related quality of life in colorectal cancer patients [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29
  • Neuropathy [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
  • Anxiety [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Spielberger State-Trait Anxiety Inventories (STAI), consisting of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
  • Depression [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed by the Center for Epidemiological Studies-Depression scale (CES-D), a brief self-report questionnaire which consists of 20 questions. Scores on the CES-DC range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms.
  • Leisure-time physical activity [ Time Frame: At 0 and 12 weeks from study start ]
    Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
  • Perceived barriers to physical activity [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 24 items plus a write-in option.
  • Exercise Confidence [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
  • Social support [ Time Frame: At 0 and 12 weeks from study start ]
    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II
Official Title  ICMJE Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
Intervention  ICMJE Behavioral: Fitbit and Text Messages
Physical activity tracker wristband and daily text messages delivered to the participants' phones.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Fitbit and Text Messages
  • No Intervention: Usual Care
    Participants randomized to usual care receive print materials at baseline.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2020)
44
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2018)
48
Actual Study Completion Date  ICMJE August 21, 2020
Actual Primary Completion Date August 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03524716
Other Study ID Numbers  ICMJE 174525
NCI-2018-00621 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin L Van Blarigan, ScD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP