Breast Cancer Clinical Trial
— PAMCapOfficial title:
Feasibility of Activity Monitoring in Patients With Cancer: Physical Activity Monitoring in Cancer Patients (PAMCap)
Verified date | May 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an open label feasibility pilot study of commercially available physical activity monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 15, 2017 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent - Age 18 or above - Receiving or planning to receive outpatient therapy for any cancer - Baseline ECOG status 0-2; - Speak and understand English as all Psychological assessment tools included in this study have not been validated in Spanish; - Access to smartphone device compatible to sync with PAM Device Exclusion Criteria: - Recent injury which may result in impaired mobility; - Major surgery within 4 weeks or till recovery to baseline functioning (per patient) whichever is shorter; - Inability to comply with study requirement; - Medical, psychiatric condition which in the investigators opinion will affect the successful completion of study; - Current use of a wearable PAM device as defined by use of PAM device in the last 6 months |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Use PAM Device | The primary endpoint of the study is the feasibility defined by subjects who use a PAM device for more than 42 of 84 days in the observation period (12 weeks +/- 14 days) | Week 6 until week 12 | |
Secondary | Number of Steps | The number of steps will be collected over the course of 12 weeks to help determine the amount of physical activity is being done. The Physical activity monitor is able to track this. | 12 Weeks (+/- 14 days) | |
Secondary | Distance Walked | The distance walked will be collected over the course of 12 weeks to help determine the amount of physical activity is being done. The Physical activity monitor is able to track this. | 12 Weeks (+/- 14 days) | |
Secondary | Time Spent in Activity | The time spent in Activity will be collected over the course of 12 weeks to help determine the amount of physical activity is being done. The Physical activity monitor is able to track this. | 12 Weeks (+/- 14 days) | |
Secondary | Eastern Cooperative Oncology Group Performance Status | ECOG assessment data will be extracted by the research team from the Electronic Medical Record. | Baseline and every 4 weeks for 12 weeks (+/-14 days) | |
Secondary | Functional Assessment of Cancer Therapy. (FACT-G) | The FACT-G is a 27-item (self-assessment)scale designed to measure multidimensional quality of life in breast cancer patients. | Baseline and every 4 weeks for 12 weeks (+/-14 days) | |
Secondary | Quick Inventory of Depressive Symptomatology (QIDS-SR) | The QIDS-SR16 is a 16-item (self assessment) version of the 30-item Inventory of Depressive Symptomatology (IDS) designed to assess severity of depression-specific symptoms. | Baseline and every 4 weeks for 12 weeks (+/-14 days) | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item (self assessment) scale designed to assess sleep quality and disturbances. | Baseline and every 4 weeks for 12 weeks (+/-14 days) | |
Secondary | Brief Fatigue Inventory (BFI) | The BFI is a 9-item (self assessment) scale designed to assess fatigue in cancer patients. | Baseline and every 4 weeks for 12 weeks (+/-14 days) |
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