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Colon CancerSmart PaceNCT02966054

Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial

A study testing Digital Health Physical Activity Intervention Group in people with Colon Cancer and Rectum 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

Epidemiologic data consistently indicate that colorectal cancer survivors can improve their quality-of-life and prognosis by engaging in physical activity. This study aims to build on this epidemiologic work and translate the findings to inform and change patient behavior. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer, Rectum Cancer
What is being tested?
Digital Health Physical Activity Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Aug 2014to 20 Jun 2017
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

  • stage I-III colon or rectal adenocarcinoma
  • completed standard cytotoxic chemotherapy if medically indicated
  • be considered disease-free at baseline
  • be able to speak and read English
  • have no contra-indication to moderate to vigorous aerobic exercise
  • be able to walk unassisted
Show all 9Show fewer
  • be inactive at baseline (<150 min/week of moderate physical activity)
  • have access to a mobile phone
  • be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94158

Other trials in United States

About this study

Epidemiologic data consistently indicate that colorectal cancer survivors can improve their quality-of-life and prognosis by engaging in physical activity. This study aims to build on this epidemiologic work and translate the findings to inform and change patient behavior. The specific aims are to: (1) Develop a mobile technology physical activity intervention among colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot randomized controlled trial utilizing mobile technology to increase physical activity among 40 men and women who have completed standard cytotoxic chemotherapy for primary stage I-III colorectal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants in the intervention arm will receive a Fitbit® for self-monitoring, interactive text messages, and educational print materials; participants in the control arm will receive educational print materials at baseline and will be given a Fitbit® after completion of the 3-mo. follow-up assessment.

Being tested
Digital Health Physical Activity Intervention Group
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • Digital Health Physical Activity Intervention GroupBehavioural

    Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks

Study groups in NCT02966054
Study groupRoleWhat they receive
InterventionExperimentalPatients will be provided with a booklet from the UCSF Dept. of Physical Therapy and Rehabilitation Science: "Moving Through Cancer: A Guide to Exercise for Cancer Survivors". The intervention group will be given a Fitbit® Flex to wear throughout the study and will receive daily text messages to support increased physical activity.
Receives: Behavioral: Digital Health Physical Activity Intervention Group
ControlNo interventionPatients in the control arm will be provided with a booklet at baseline from the UCSF Dept. of Physical Therapy and Rehabilitation Science: "Moving Through Cancer: A Guide to Exercise for Cancer Survivors".

What is being measured

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

  1. Physical activity

    Change in total physical activity assessed via ActiGraph GT3X+ accelerometers

    Measured: 12-weeks

Secondary outcomes (4)

  1. Fitbit wear time (# days with data / # days of observation)

    Measured: 12-weeks

  2. Response to text messages (# of messages responded to / # of messages that asked for a response)

    Measured: 12-weeks

  3. Quality-of-life (SF--36)

    Measured: 12-weeks

  4. Colorectal cancer-specific quality-of-life (FACT-C)

    Measured: 12-weeks

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study startAug 2014
  3. Primary completion20 Jun 2017
  4. Study completion20 Jun 2017

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966054
Sponsor's protocol ID
14-14452
Acronym
Smart Pace
Status last verified
Apr 2018
First submitted
9 Nov 2016
Last updated
9 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chan H, Van Loon K, Kenfield SA, Chan JM, Mitchell E, Zhang L, Paciorek A, Joseph G, Laffan A, Atreya C, Fukuoka Y, Miaskowski C, Meyerhardt JA, Venook AP, Van Blarigan EL. Quality of life of colorectal cancer survivors participating in a pilot randomized controlled trial of physical activity trackers and daily text messages. Support Care Cancer. 2022 May;30(5):4557-4564. doi: 10.1007/s00520-022-06870-5. Epub 2022 Feb 4.

    PubMed 35119520

  • Van Blarigan EL, Chan H, Van Loon K, Kenfield SA, Chan JM, Mitchell E, Zhang L, Paciorek A, Joseph G, Laffan A, Atreya CE, Fukuoka Y, Miaskowski C, Meyerhardt JA, Venook AP. Self-monitoring and reminder text messages to increase physical activity in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial. BMC Cancer. 2019 Mar 11;19(1):218. doi: 10.1186/s12885-019-5427-5.

    PubMed 30866859

Questions about this trial

What is this clinical trial studying?

A study testing Digital Health Physical Activity Intervention Group in people with Colon Cancer and Rectum 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 9 inclusion and 0 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 9 Apr 2018. 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?

Physical activity (time frame: 12-weeks). 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 NCT02966054, which also lists 2 linked publications.

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 9 Apr 2018.

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