Cancer Clinical Trial
Official title:
Replacing Sedentary Time With Light Activity
Verified date | August 2018 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Move for Your Health Pilot Study is a 16-week study in older cancer survivors to replace and break-up sedentary activity with short bouts of light physical activity.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 20, 2017 |
Est. primary completion date | July 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age 60 years or older at the time of enrollment - Diagnosed with local or regionally staged cancer (any site) and completed primary treatment - Own a smartphone capable of running the "Jawbone UP2" app - Willingness to be randomized to any of the 3 study arms, attend 2 clinic visits, and wear activity monitors (activPAL and actiGraph) at weeks 1 and 16 for 7 days; "Jawbone UP2" wristband monitor during weeks 2-16 during waking hours. - Able to read, speak, and understand English. - Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker) - Residence within Bernalillo County or the four surrounding counties (to reduce travel burden) Exclusion Criteria: - Currently participating in a program to decrease sedentary time or increase physical activity - Paid employment or volunteer position for greater than 20 hours per week - Severe impairments or pre-existing medical limitations for engaging in daily light physical activity - Wrist size >20 cm |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cindy Blair, PhD, MPH | American Cancer Society, Inc., University of New Mexico Cancer Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total volume of sedentary time (hours/day) | Change in the average number of hours/day of sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention | Baseline to 16-weeks | |
Primary | Change in the number of breaks in sedentary time | Change in the average number of breaks in sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention | Baseline to 16-weeks | |
Secondary | Change in light physical activity | Change in the average number of hours per day spent in light physical activity (or higher intensity) measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention | Baseline to 16-weeks | |
Secondary | Change in steps per day | Change in the average number of steps per day measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention | Baseline to 16-weeks | |
Secondary | Change in physical performance | Change in the average physical performance score as measured by the Short Physical Performance Battery (SPPB). This performance battery includes chair stands, balance tests, and the 8-foot usual gait speed. Each subscale score ranges from 0 (cannot do) to 4 (good performance). The subscales are summed for a total score, which ranges from 0 (lowest level of performance) to 12 (highest level of performance) | Baseline to 16-weeks | |
Secondary | Change in physical functioning (ranging from basic to strenuous activities) | Change in self-reported physical functioning as measured by the 36-item Short Form Survey (SF-36) physical functioning subscale. Raw scores range from 0 (worst functioning) to 100 (best functioning) | Baseline to 16-weeks | |
Secondary | Change in health-related quality of life (self-reported mental, physical, and social health and well-being) | Change in quality of life as measured by the SF-36; each of the 8 subscales and 2 component summary scores; scores based on proprietary algorithm from Optum; higher scores represent better quality of life) | Baseline to 16-weeks | |
Secondary | Change in cardiometabolic markers | Change in fasting glucose, insulin and lipids, as well as high-sensitivity C-Reactive Protein (CRP) | Baseline to 16-weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|