FITBIT FOR CANCER: STUDY TESTS IF STEP COUNTS PREDICT SURVIVAL

NCT ID NCT01365169

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study is testing whether wearing a fitness tracker (like a Fitbit) can give doctors a better picture of how active cancer patients are, and whether that activity level relates to how well they are doing overall. About 590 people with various cancers will wear activity monitors and have their physical function assessed by their doctor. The goal is to see if objective activity data can help predict survival and improve patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2011

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1) * Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4) * Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study) * Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase) * Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1) * Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3) * History of any cancer, other than non-melanoma skin cancer (Arm 4) * Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4) * Has a valid home address and functioning home telephone number (Arm 4) * Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4) * Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study) * Fluent in English (PCS study) * Must have telephone access and agree to engage with research personnel using telephone (PCS study) * Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study) * Fluent in English (TAPS study) * Age 18 years or older (TAPS study) * ECOG performance status score between 0-3 (TAPS study) Exclusion Criteria: * Major surgery in the past 8 weeks (Arms 1 and 4) * Self-reports hypertension that is not being monitored by a physician and is not being managed with either medication, observation, or lifestyle change (Pre-pilot phase, Arms 1-3) * Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4) * Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2) * Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3) * Zubrod performance status \> 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3) * Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: the study does not exclude those receiving treatment for non-melanoma skin cancer) (Arms 2 and 3) * History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only) * Active substance use disorder (diagnosed or strongly suspected) (Arm 4) * Currently enrolled in protocol 2014-0712 (PCS study) * No home access to internet (PCS study) * No home WiFi connection (PCS study) * During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study) * Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study) * Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study) * Poorly-controlled pain with a self-reported pain score of 7/10 at the time of enrollment (PCS study) * Myopathic or rheumatologic disease that impacts physical function (PCS study) * Has a pacemaker or other internal medical device, or reports being pregnant (PCS study) * Currently enrolled in protocol 2017-0198 (PCS study) * Demonstration of overt cognitive difficulty as demonstrated by not being clearly oriented to time or person or place (TAPS study)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant head and neck neoplasm Malignant neoplasm Metastatic malignant neoplasm in the neck Metastatic malignant neoplasm in the uterine cervix Metastatic or locally unresectable solid tumor Pancreatic adenocarcinoma Pancreatic neuroendocrine carcinoma Recurrent colorectal carcinoma Stage I colorectal cancer ajcc V6 and V7 Stage I hypopharyngeal carcinoma ajcc V7 Stage I major salivary gland cancer ajcc V7 Stage I nasopharyngeal carcinoma ajcc V7 Stage I oral cavity cancer ajcc V6 and V7 Stage I oropharyngeal carcinoma ajcc V6 and V7 Stage II colorectal cancer ajcc V7 Stage II hypopharyngeal carcinoma ajcc V6 and V7 Stage II major salivary gland cancer ajcc V7 Stage II nasopharyngeal carcinoma ajcc V7 Stage II oral cavity cancer ajcc V6 and V7 Stage II oropharyngeal carcinoma ajcc V6 and V7 Stage IIA colorectal cancer ajcc V7 Stage IIB colorectal cancer ajcc V7 Stage IIC colorectal cancer ajcc V7 Stage III colorectal cancer ajcc V7 Stage III hypopharyngeal carcinoma ajcc V7 Stage III laryngeal cancer ajcc V6 and V7 Stage III major salivary gland cancer ajcc V7 Stage III nasopharyngeal carcinoma ajcc V7 Stage III oral cavity cancer ajcc V6 and V7 Stage III oropharyngeal carcinoma ajcc V7 Stage IIIA colorectal cancer ajcc V7 Stage IIIB colorectal cancer ajcc V7 Stage IIIC colorectal cancer ajcc V7 Stage IV colorectal cancer ajcc V7 Stage IVA colorectal cancer ajcc V7 Stage IVA hypopharyngeal carcinoma ajcc V7 Stage IVA laryngeal cancer ajcc V7 Stage IVA major salivary gland cancer ajcc V7 Stage IVA nasopharyngeal carcinoma ajcc V7 Stage IVA oral cavity cancer ajcc V6 and V7 Stage IVA oropharyngeal carcinoma ajcc V7 Stage IVB colorectal cancer ajcc V7 Stage IVB hypopharyngeal carcinoma ajcc V7 Stage IVB laryngeal cancer ajcc V7 Stage IVB major salivary gland cancer ajcc V7 Stage IVB nasopharyngeal carcinoma ajcc V7 Stage IVB oral cavity cancer ajcc V6 and V7 Stage IVB oropharyngeal carcinoma ajcc V7

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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