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Colorectal CancerSmartPaceIINCT03524716

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

A study testing Fitbit and Text Messages in people with Colorectal Cancer and Colon Cancer, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Colon Cancer, Rectal Cancer
What is being tested?
Fitbit and Text Messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
6 Mar 2018to 21 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace 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.

Being tested
Fitbit and Text Messages
Keywords
physical activity, digital health, text messages, intervention, exercise, randomized, Fitbit
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fitbit and Text MessagesBehavioural

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

Study groups in NCT03524716
Study groupRoleWhat they receive
Fitbit and Text MessagesExperimentalParticipants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.
Receives: Behavioral: Fitbit and Text Messages
Usual CareNo interventionParticipants randomized to usual care receive print materials at baseline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fitbit wear time

    Number of study days Fitbit is worn

    Measured: up to 12 weeks from study start

  2. Acceptability of the intervention

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

    Measured: At 12 weeks from study start

  3. Text message response rate

    Measured: up to 12 weeks from study start

Secondary outcomes (15)

  1. Objective physical activity

    Minutes of moderate-to-vigorous physical activity per week measured by accelerometer

    Measured: At 0 weeks and 12 weeks from study start

  2. Fatigue

    Lee Fatigue Scale

    Measured: At 0 and 12 weeks from study start

  3. Cardiorespiratory fitness

    6 minute walk test

    Measured: At 0 and 12 weeks from study start

  4. Anthropometrics, Waist circumference

    Measured: At 0 and 12 weeks from study start

  5. Anthropometrics, Body weight

    Measured: At 0 and 12 weeks from study start

  6. Sleep quality

    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.

    Measured: At 0 and 12 weeks from study start

  7. Health-related quality of life in cancer patients

    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30

    Measured: At 0 and 12 weeks from study start

  8. Health-related quality of life in colorectal cancer patients

    Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29

    Measured: At 0 and 12 weeks from study start

  9. Neuropathy

    Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.

    Measured: At 0 and 12 weeks from study start

  10. Anxiety

    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.

    Measured: At 0 and 12 weeks from study start

  11. Depression

    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.

    Measured: At 0 and 12 weeks from study start

  12. Leisure-time physical activity

    Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.

    Measured: At 0 and 12 weeks from study start

  13. Perceived barriers to physical activity

    Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.

    Measured: At 0 and 12 weeks from study start

  14. Exercise Confidence

    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.

    Measured: At 0 and 12 weeks from study start

  15. Social support

    Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.

    Measured: At 0 and 12 weeks from study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start6 Mar 2018
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524716
Sponsor's protocol ID
174525
Other IDs
NCI-2018-00621
Acronym
SmartPaceII
Status last verified
Aug 2020
First submitted
4 Apr 2018
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.

Publications

  • 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.

    PubMed 35014958

Questions about this trial

What is this clinical trial studying?

A study testing Fitbit and Text Messages in people with Colorectal Cancer and Colon Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fitbit wear time (time frame: up to 12 weeks from study start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03524716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

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