Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Study will be conducted for 12 weeks (+/-14 days) of monitoring.

BASELINE ASSESSMENTS Baseline assessment should be performed within 14 days of Week 1.

1. Signed informed consent;

2. ECOG Performance Status per treating physician (chart abstraction of available data);

3. Pathology report confirming cancer diagnosis;

4. Psychosocial assessment questionnaires;

5. Blood for correlative biomarkers (10 ml);

6. Documentation of planned/ongoing chemotherapy regimen

ON-STUDY ASSESSMENTS

1. Physical Activity Monitor (PAM)

1. Fitbit (PAM) devices will be provided by investigators for the period of the study;

2. Introduction to the device and instructions on use and care will be provided based on commercial marketing material;

3. Subjects will be assisted in setting up Fitbit device on smart phone;

4. Subjects will be asked to wear Fitbit device continuously for 12 weeks - however, the device should not be worn during bathing or showering;

5. Subjects will be asked to sync their Fitbit devices to the database at least once a week;

6. Clinical coordinator may send phone or text reminders to encourage syncing as Fitbit device can only record 1 weeks' worth of data;

7. Cost Coverage

8. Investigators will purchase devices prior to start of study with grant funding.

9. PAM Accountability

10. Investigator and investigator site are responsible for maintaining accurate inventory and accountability logs for the devices.

11. Subjects will be asked to sign a form upon receipt and return of device as applicable.

2. 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

3. 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.

4. 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.

5. Pittsburgh Sleep Quality Index (PSQI) (See Appendix H).9

a. The PSQI is a 19-item scale designed to assess sleep quality and disturbances.

6. Brief Fatigue Inventory (BFI) (See Appendix I).10

a. The BFI is a 9-item scale designed to assess fatigue in cancer patients.

7. Biomarker and DNA Blood Tests

1. Blood samples will be collected at each study visit indicated by the study calendar. Process samples according to the sample processing instructions. 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;

2. 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;

3. Keep originals of these documents in the subject's chart;

4. Samples will be analyzed using a multiplexed ELISA method (Meso Scale Discovery) for IL-1beta, IL-6, IL-10 and TNF-alpha;

5. With explicit participant consent, samples will also be processed for DNA and stored for future analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02583815
Study type Observational
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase
Start date August 2015
Completion date September 15, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A