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Completed

NCT Number: NCT03524716

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

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.

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Key information

Conditions

Colorectal Cancer Behavior Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FitBit and Text Messages

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: SmartPaceII

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 15, 2018
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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