Physical ActivityNCT03233581
Improving Physical Activity in Young Adult Cancer Survivors
A study testing Fitbit + Facebook + Coaching Group and Fitbit only in people with Physical Activity and Quality of Life, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Quality of Life
- What is being tested?
- Fitbit + Facebook + Coaching Group and Fitbit only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2017to 22 May 2018
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Does not meet recommended guidelines for physical activity (PA,150 min of moderate activity or 75 min of vigorous activity)
- Currently between 1.0-5.0 years from the completion of active cancer therapy
- Able to read and speak English
- Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group
Who cannot join
- Pregnant or planning on becoming pregnant in the next year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Seattle Children's Research Institute
Seattle, Washington, 98145-5005
About this study
The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39 years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.
Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the Fitbit Flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at Time 1 and Time 2.
- Conditions
- Physical Activity, Quality of Life
- Being tested
- Fitbit + Facebook + Coaching Group, Fitbit only
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit + Facebook + Coaching GroupBehavioural
Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.
Fitbit onlyBehavioural
Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit + Facebook + Health Coaching | Experimental | Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support. Receives: Behavioral: Fitbit + Facebook + Coaching Group |
| Usual care control with Fitbit only | Active comparator | Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support. Receives: Behavioral: Fitbit only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)
Measured: up to week 12
Secondary outcomes (2)
Post-intervention health related quality of life (measured by questionnaire)
Measured: up to week 12
Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)
Measured: up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start12 Sep 2017
- Primary completion6 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Jason Mendoza, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233581
- Sponsor's protocol ID
- Fitbit YA 9865
- Status last verified
- May 2018
- First submitted
- 24 Jul 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson AM, Baker KS, Haviland MJ, Syrjala KL, Abbey-Lambertz M, Chow EJ, Mendoza JA. A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2022 Aug;11(4):379-388. doi: 10.1089/jayao.2021.0056. Epub 2021 Oct 22.
PubMed 34677081Miropolsky EM, Scott Baker K, Abbey-Lambertz M, Syrjala K, Chow EJ, Ceballos R, Mendoza JA. Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study. J Adolesc Young Adult Oncol. 2020 Jun;9(3):410-417. doi: 10.1089/jayao.2019.0072. Epub 2020 Jan 13.
PubMed 31928489
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity in Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT03233581
- Acronym / sponsor ID
- Fitbit YA 9865
- Conditions
- Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39 years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.
Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the Fitbit Flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at Time 1 and Time 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit + Facebook + Health Coaching | Experimental | Behavioral: Fitbit + Facebook + Coaching GroupParticipants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support. |
| Usual care control with Fitbit only | Active comparator | Behavioral: Fitbit onlyParticipants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Does not meet recommended guidelines for physical activity (PA,150 min of moderate activity or 75 min of vigorous activity)
- Currently between 1.0-5.0 years from the completion of active cancer therapy
- Able to read and speak English
- Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group
Key exclusion criteria (1 listed)
- Pregnant or planning on becoming pregnant in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit + Facebook + Coaching GroupParticipants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support. | Behavioural | Fitbit + Facebook + Health Coaching |
| Fitbit onlyParticipants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support. | Behavioural | Usual care control with Fitbit only |
Primary outcome
Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)
Time frame: up to week 12
2 secondary outcomes
Post-intervention health related quality of life (measured by questionnaire)
Time frame: up to week 12
Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)
Time frame: up to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Derived from this study: PubMed 34677081Johnson AM, Baker KS, Haviland MJ, Syrjala KL, Abbey-Lambertz M, Chow EJ, Mendoza JA. A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2022 Aug;11(4):379-388. doi: 10.1089/jayao.2021.0056. Epub 2021 Oct 22.
- Derived from this study: PubMed 31928489Miropolsky EM, Scott Baker K, Abbey-Lambertz M, Syrjala K, Chow EJ, Ceballos R, Mendoza JA. Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study. J Adolesc Young Adult Oncol. 2020 Jun;9(3):410-417. doi: 10.1089/jayao.2019.0072. Epub 2020 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit + Facebook + Coaching Group and Fitbit only in people with Physical Activity and Quality of Life, run by Seattle Children's Hospital at 2 sites 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 4 inclusion and 1 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 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers) (time frame: up to week 12). 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 NCT03233581, 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 25 May 2018.