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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colon Cancer Rectal Cancer Behavioral: Fitbit and Text Messages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : August 21, 2020
Actual Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Fitbit and Text Messages
Physical activity tracker wristband and daily text messages delivered to the participants' phones.

No Intervention: Usual Care
Participants randomized to usual care receive print materials at baseline.



Primary Outcome Measures :
  1. Fitbit wear time [ Time Frame: up to 12 weeks from study start ]
    Number of study days Fitbit is worn

  2. 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.

  3. Text message response rate [ Time Frame: up to 12 weeks from study start ]

Secondary Outcome Measures :
  1. 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

  2. Fatigue [ Time Frame: At 0 and 12 weeks from study start ]
    Lee Fatigue Scale

  3. Cardiorespiratory fitness [ Time Frame: At 0 and 12 weeks from study start ]
    6 minute walk test

  4. Anthropometrics, Waist circumference [ Time Frame: At 0 and 12 weeks from study start ]
  5. Anthropometrics, Body weight [ Time Frame: At 0 and 12 weeks from study start ]
  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524716


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Erin L Van Blarigan, ScD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03524716    
Other Study ID Numbers: 174525
NCI-2018-00621 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
physical activity
digital health
text messages
intervention
exercise
randomized
Fitbit
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases