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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.
Study will be conducted for 12 weeks (+/-14 days) of monitoring.
BASELINE ASSESSMENTS Baseline assessment should be performed within 14 days of Week 1.
ON-STUDY ASSESSMENTS
Physical Activity Monitor (PAM)
ECOG - Eastern Cooperative Oncology Group Performance Status 0 - Fully active, able to carry on all pre-disease performance without restriction; 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 - Completely disabled -- cannot carry on any self-care. Totally confined to bed or chair; 5 - Dead
Functional Assessment of Cancer Therapy - General (FACT-G).
a. The FACT-G is a 27-item scale designed to measure multidimensional quality of life in breast cancer patients.
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR116) .
a. The QIDS-SR16 is a 16-item version of the 30-item Inventory of Depressive Symptomatology (IDS) designed to assess severity of depression-specific symptoms.
Pittsburgh Sleep Quality Index (PSQI) (See Appendix H).9
a. The PSQI is a 19-item scale designed to assess sleep quality and disturbances.
Brief Fatigue Inventory (BFI) (See Appendix I).10
a. The BFI is a 9-item scale designed to assess fatigue in cancer patients.
Biomarker and DNA Blood Tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Patients | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Distance Walked |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Beg, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390-8852 | United States |
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Blood samples will be collected at each study visit (Baseline, then every weeks until week 12 (+/-14 days). Prior to storage, complete the sample inventory logs for each subject so that specimen chain of custody can be established. Samples will be frozen at -80°C until the time of analysis.
Include in each shipment batch copies of: 1) the blood collection source documents for each patient; and 2) copies of each subjects specimen inventory form
Keep originals of these documents in the subject's chart
Samples will be analyzed using a multiplexed ELISA method (Meso Scale Discovery) for IL-1beta, IL-6, IL-10 and TNF-alpha
With explicit participant consent, samples will also be processed for DNA and stored for future analysis.
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D001943 | Breast Neoplasms |
| D014565 | Urogenital Neoplasms |
| D007938 | Leukemia |
| D008175 | Lung Neoplasms |
| D012878 | Skin Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004700 | Endocrine System Diseases |
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