Colorectal CancerDASHNCT03211806
Detecting Activity to Support Healing
A study testing Sedentary Behavior and Bluetooth-enabled activity monitor in people with Colorectal Cancer and Peritoneal Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle
- What is being tested?
- Sedentary Behavior and Bluetooth-enabled activity monitor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 14 May 2021
- 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
- Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside
- Ability to stand and walk unassisted prior to surgery
- Identified at least two weeks prior to their scheduled surgery date
Who cannot join
- Unable to read and write in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology to Reduce Sedentary Behavior Before and After Cancer Surgery
The goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Sedentary behavior increases markedly after surgery and hospitalization, and reducing sedentary behavior around the time of cancer surgery could reduce risk while also empowering cancer patients to take a more active role in their recovery.
Read the detailed description
Colorectal or peritoneal cancer patients scheduled for surgical resection (n=60) will be randomized to either the sedentary behavior intervention or monitoring only. The intervention will use a Bluetooth-enabled activity monitor to detect prolonged sedentary bouts, which will prompt a message delivered via smartphone suggesting that patients walk. The intervention will begin at least two weeks prior to scheduled surgery and will continue through the first 30 days at home following hospital discharge. Outcomes will include objective activity and sedentary behavior, patient-reported symptoms and quality of life using standardized instruments, inflammatory biomarkers, and morbidity and hospital readmission 30-days after index discharge.
- Conditions
- Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle
- Being tested
- Sedentary Behavior, Bluetooth-enabled activity monitor
- Medical subject headings
- Colorectal Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary BehaviorBehavioural
Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor
Bluetooth-enabled activity monitorDevice
Monitoring activity using a Bluetooth-enabled activity monitor
| Study group | Role | What they receive |
|---|---|---|
| Sedentary behavior intervention group | Experimental | This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts Receives: Behavioral: Sedentary Behavior; Device: Bluetooth-enabled activity monitor |
| Monitoring-only group | Active comparator | This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior Receives: Device: Bluetooth-enabled activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Percentage of those enrolled who completed the program
Measured: 30 days post-discharge
Acceptability
Post-intervention interviews will be conducted to assess acceptability of the program
Measured: 30-days post-discharge
Adherence
Percentages of assessments completed and prompts after which steps were detected
Measured: 30-days post-discharge
Secondary outcomes (9)
Total objective sedentary behavior
A Bluetooth enabled activity monitor worn throughout the study will estimate the total amount of time spent in sedentary behavior per day
Measured: Change from baseline to 30 days post-discharge
Objective physical activity
A Bluetooth enabled activity monitor worn throughout the study will estimate of number of steps/day.
Measured: Change from baseline to 30 days post-discharge
Patient-reported symptoms
Depressive (CES-D) and physical symptom severity (adapted from the MD Anderson Symptom Inventory)
Measured: Change from baseline to 30 days post-discharge
Patient-reported quality of life
Quality of life (FACT)
Measured: Change from baseline to 30 days post-discharge
Inflammatory biomarkers
Plasma levels of IL-6 and CRP
Measured: 2 weeks post-discharge
Morbidity
Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records
Measured: 30 days post-discharge
Mean sedentary behavior bout
A Bluetooth enabled activity monitor will be used to estimate mean daily sedentary bout
Measured: Change from baseline to 30 days post-discharge
Maximum sedentary behavior bout
A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout
Measured: Change from baseline to 30 days post-discharge
Readmission
Readmissions within 30 days after index hospital discharge will be extracted from medical records
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start6 Jun 2019
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carissa Low, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211806
- Sponsor's protocol ID
- 16-075
- Other IDs
- K07CA204380
- Acronym
- DASH
- Status last verified
- May 2021
- First submitted
- 23 Jan 2017
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Low CA, Danko M, Durica KC, Vega J, Li M, Kunta AR, Mulukutla R, Ren Y, Sereika SM, Bartlett DL, Bovbjerg DH, Dey AK, Jakicic JM. A Real-Time Mobile Intervention to Reduce Sedentary Behavior Before and After Cancer Surgery: Pilot Randomized Controlled Trial. JMIR Perioper Med. 2023 Jan 12;6:e41425. doi: 10.2196/41425.
PubMed 36633893
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology to Reduce Sedentary Behavior Before and After Cancer Surgery
- ClinicalTrials.gov ID
- NCT03211806
- Acronym / sponsor ID
- DASH / 16-075
- Conditions
- Colorectal Cancer, Peritoneal Cancer, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 7 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 goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Sedentary behavior increases markedly after surgery and hospitalization, and reducing sedentary behavior around the time of cancer surgery could reduce risk while also empowering cancer patients to take a more active role in their recovery.
Detailed description
Colorectal or peritoneal cancer patients scheduled for surgical resection (n=60) will be randomized to either the sedentary behavior intervention or monitoring only. The intervention will use a Bluetooth-enabled activity monitor to detect prolonged sedentary bouts, which will prompt a message delivered via smartphone suggesting that patients walk. The intervention will begin at least two weeks prior to scheduled surgery and will continue through the first 30 days at home following hospital discharge. Outcomes will include objective activity and sedentary behavior, patient-reported symptoms and quality of life using standardized instruments, inflammatory biomarkers, and morbidity and hospital readmission 30-days after index discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group
| Arm | Type | Receives |
|---|---|---|
| Sedentary behavior intervention group | Experimental | Behavioral: Sedentary Behavior, Device: Bluetooth-enabled activity monitorThis group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts |
| Monitoring-only group | Active comparator | Device: Bluetooth-enabled activity monitorThis group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside
- Ability to stand and walk unassisted prior to surgery
- Identified at least two weeks prior to their scheduled surgery date
Key exclusion criteria (1 listed)
- Unable to read and write in 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 |
|---|---|---|
| Sedentary BehaviorMessages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor | Behavioural | Sedentary behavior intervention group |
| Bluetooth-enabled activity monitorMonitoring activity using a Bluetooth-enabled activity monitor | Device | Monitoring-only group, Sedentary behavior intervention group |
Primary outcome
Retention
Time frame: 30 days post-discharge
Percentage of those enrolled who completed the program
Acceptability
Time frame: 30-days post-discharge
Post-intervention interviews will be conducted to assess acceptability of the program
Adherence
Time frame: 30-days post-discharge
Percentages of assessments completed and prompts after which steps were detected
9 secondary outcomes
Total objective sedentary behavior
Time frame: Change from baseline to 30 days post-discharge
Objective physical activity
Time frame: Change from baseline to 30 days post-discharge
Patient-reported symptoms
Time frame: Change from baseline to 30 days post-discharge
Patient-reported quality of life
Time frame: Change from baseline to 30 days post-discharge
Inflammatory biomarkers
Time frame: 2 weeks post-discharge
Morbidity
Time frame: 30 days post-discharge
Mean sedentary behavior bout
Time frame: Change from baseline to 30 days post-discharge
Maximum sedentary behavior bout
Time frame: Change from baseline to 30 days post-discharge
Readmission
Time frame: 30 days post-discharge
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 24 May 2021.
- Derived from this study: PubMed 36633893Low CA, Danko M, Durica KC, Vega J, Li M, Kunta AR, Mulukutla R, Ren Y, Sereika SM, Bartlett DL, Bovbjerg DH, Dey AK, Jakicic JM. A Real-Time Mobile Intervention to Reduce Sedentary Behavior Before and After Cancer Surgery: Pilot Randomized Controlled Trial. JMIR Perioper Med. 2023 Jan 12;6:e41425. doi: 10.2196/41425.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary Behavior and Bluetooth-enabled activity monitor in people with Colorectal Cancer and Peritoneal Cancer, run by University of Pittsburgh 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 3 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 24 May 2021. 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?
Retention (time frame: 30 days post-discharge). 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 NCT03211806, 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 24 May 2021; AzTrials last refreshed its copy on 28 Oct 2026.