CancerNCT02824861
Bemobile Intervention to Support Physical Activity in Cancer Survivors
A study testing Bemobile in people with Cancer, run by University of Vermont at 1 site in United States.
Trial summary
This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Bemobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Nov 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer diagnosis
- Impending graduation from oncology rehabilitation
Who cannot join
- Metastatic cancer
- Concurrent radiation or chemotherapy
- No cell phone
- Inability to read or speak English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors
This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. In Phase 1 all participants received the full intervention. In phase II participants are randomly assigned to receive the full intervention or a fitbit only.
Read the detailed description
This intervention, offered to participants after completing oncology rehabilitation, integrates known preferences and determinants of physical activity participation in women and breast cancers survivors including social support, professional guidance, self-efficacy, goal setting, self-regulation, and environmental awareness delivered through accessible technology. For the iteration phase, the investigators will conduct an initial, abbreviated intervention wave lasting 4 weeks; the investigators will then incorporate participant input and feedback on the specific components to refine the intervention prior to a pilot trial. Means of delivering the components include communication and support through tailored text messaging, health coaching phone calls, self-monitoring of physical activity through a wearable sensor, and environmental assessment of community physical activity options (e.g., parks, fitness centers, trails) based on global positioning system information.
- Conditions
- Cancer
- Being tested
- Bemobile
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemobileBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Text Intervention | Experimental | Participants receive text messages to a personal cell phone over 8 weeks, wear a fitbit to monitor physical activity, and communicate with a health coach intermittently over 2 weeks Receives: Behavioral: Bemobile |
| Active Control | Active comparator | Participants receive and wear a fitbit only for 8 weeks Receives: Behavioral: Bemobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Step counts
Mean daily step counts as assessed by Actigraph Accelerometer
Measured: 8 weeks
Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)
Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer
Measured: 8 weeks
Secondary outcomes (4)
Change in Weekly average of mean daily step counts
Step counts assessed during the intervention with the Fitbit One
Measured: 8 weeks
Change from Baseline in Self-efficacy to perform exercise
Scale developed by Garcia and King
Measured: 8 weeks
Change from Baseline in Self-regulation
Scale Developed R. Umstattd
Measured: 8 weeks
Change from Baseline in Fatigue
Fatigue Symptom Inventory (FSI)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2015
- Primary completion30 Jul 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Gell, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824861
- Sponsor's protocol ID
- CHRMS15-405
- Other IDs
- VCC1504
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to make individual participant data available
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors
- ClinicalTrials.gov ID
- NCT02824861
- Acronym / sponsor ID
- CHRMS15-405
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. In Phase 1 all participants received the full intervention. In phase II participants are randomly assigned to receive the full intervention or a fitbit only.
Detailed description
This intervention, offered to participants after completing oncology rehabilitation, integrates known preferences and determinants of physical activity participation in women and breast cancers survivors including social support, professional guidance, self-efficacy, goal setting, self-regulation, and environmental awareness delivered through accessible technology. For the iteration phase, the investigators will conduct an initial, abbreviated intervention wave lasting 4 weeks; the investigators will then incorporate participant input and feedback on the specific components to refine the intervention prior to a pilot trial. Means of delivering the components include communication and support through tailored text messaging, health coaching phone calls, self-monitoring of physical activity through a wearable sensor, and environmental assessment of community physical activity options (e.g., parks, fitness centers, trails) based on global positioning system information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Intervention | Experimental | Behavioral: BemobileParticipants receive text messages to a personal cell phone over 8 weeks, wear a fitbit to monitor physical activity, and communicate with a health coach intermittently over 2 weeks |
| Active Control | Active comparator | Behavioral: BemobileParticipants receive and wear a fitbit only for 8 weeks |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer diagnosis
- Impending graduation from oncology rehabilitation
Key exclusion criteria (4 listed)
- Metastatic cancer
- Concurrent radiation or chemotherapy
- No cell phone
- Inability to read or speak English.
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 |
|---|---|---|
| Bemobile | Behavioural | Active Control, Text Intervention |
Primary outcome
Change from Baseline in Step counts
Time frame: 8 weeks
Mean daily step counts as assessed by Actigraph Accelerometer
Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)
Time frame: 8 weeks
Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer
4 secondary outcomes
Change in Weekly average of mean daily step counts
Time frame: 8 weeks
Change from Baseline in Self-efficacy to perform exercise
Time frame: 8 weeks
Change from Baseline in Self-regulation
Time frame: 8 weeks
Change from Baseline in Fatigue
Time frame: 8 weeks
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 17 Apr 2019.
- Individual participant dataSharing planned: No. No plan to make individual participant data available
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bemobile in people with Cancer, run by University of Vermont 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 2 inclusion and 4 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 17 Apr 2019. 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?
Change from Baseline in Step counts (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.