ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 213 for:    Oral Cancer | Recruiting Studies | NIH

Post-op Wellness Program for Pancreatic Cancer Patients That Uses Patient Feedback and Real-time Provider Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01365169
Recruitment Status : Recruiting
First Posted : June 3, 2011
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This pilot clinical trial explores the use of wireless collection and transmission of physical activity, nutrition, and self-reported data from patients undergoing pancreas surgery. Home-based post-operative (post-op) rehabilitation programs that feature structured walking have been found to improve post-surgical outcomes. The addition of home monitoring of biometric and self-report outcomes may enable more rapid intervention to address slow patient recovery rates.

Condition or disease Intervention/treatment Phase
Cancer Survivor Current Smoker Former Smoker Malignant Head and Neck Neoplasm Malignant Neoplasm Metastatic Malignant Neoplasm in the Neck Metastatic Malignant Neoplasm in the Uterine Cervix Pancreatic Adenocarcinoma Pancreatic Cyst Pancreatic Neuroendocrine Carcinoma Recurrent Colorectal Carcinoma Stage I Colorectal Cancer AJCC v6 and v7 Stage I Hypopharyngeal Carcinoma AJCC v7 Stage I Major Salivary Gland Cancer AJCC v7 Stage I Nasopharyngeal Carcinoma AJCC v7 Stage I Oral Cavity Cancer AJCC v6 and v7 Stage I Oropharyngeal Carcinoma AJCC v6 and v7 Stage II Colorectal Cancer AJCC v7 Stage II Hypopharyngeal Carcinoma AJCC v6 and v7 Stage II Major Salivary Gland Cancer AJCC v7 Stage II Nasopharyngeal Carcinoma AJCC v7 Stage II Oral Cavity Cancer AJCC v6 and v7 Stage II Oropharyngeal Carcinoma AJCC v6 and v7 Stage IIA Colorectal Cancer AJCC v7 Stage IIB Colorectal Cancer AJCC v7 Stage IIC Colorectal Cancer AJCC v7 Stage III Colorectal Cancer AJCC v7 Stage III Hypopharyngeal Carcinoma AJCC v7 Stage III Laryngeal Cancer AJCC v6 and v7 Stage III Major Salivary Gland Cancer AJCC v7 Stage III Nasopharyngeal Carcinoma AJCC v7 Stage III Oral Cavity Cancer AJCC v6 and v7 Stage III Oropharyngeal Carcinoma AJCC v7 Stage IIIA Colorectal Cancer AJCC v7 Stage IIIB Colorectal Cancer AJCC v7 Stage IIIC Colorectal Cancer AJCC v7 Stage IV Colorectal Cancer AJCC v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVA Hypopharyngeal Carcinoma AJCC v7 Stage IVA Laryngeal Cancer AJCC v7 Stage IVA Major Salivary Gland Cancer AJCC v7 Stage IVA Nasopharyngeal Carcinoma AJCC v7 Stage IVA Oral Cavity Cancer AJCC v6 and v7 Stage IVA Oropharyngeal Carcinoma AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Stage IVB Hypopharyngeal Carcinoma AJCC v7 Stage IVB Laryngeal Cancer AJCC v7 Stage IVB Major Salivary Gland Cancer AJCC v7 Stage IVB Nasopharyngeal Carcinoma AJCC v7 Stage IVB Oral Cavity Cancer AJCC v6 and v7 Stage IVB Oropharyngeal Carcinoma AJCC v7 Behavioral: Exercise Intervention Other: Health Telemonitoring Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To explore the feasibility and acceptability in diverse samples of cancer patients of wireless collection and transmission of data for transfer into the open-source cyberinfrastructure (CI) called Cyberinfrastructure for Comparative Effectiveness Research (CYCORE).

OUTLINE: Patients are assigned to 1 of 4 arms.

ARM I (COLORECTAL CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a global positioning system (GPS) device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

ARM II (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

ARM III (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days.

ARM IV (CANCER SURVIVORS THAT ARE CURRENT/FORMER SMOKERS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a carbon monoxide (CO) monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.

PANCREATIC CANCER STUDY (PCS): Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial
Actual Study Start Date : May 25, 2011
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


Arm Intervention/treatment
Experimental: Arm I (colorectal cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a GPS device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm III (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days.
Other: Health Telemonitoring
Use smart phone

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm IV (cancer survivors that are current/former smokers)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a CO monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
Other: Health Telemonitoring
Use CO monitor and smart phone

Other: Questionnaire Administration
Ancillary studies

Experimental: PCS (pancreatic surgery patients)
Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.
Behavioral: Exercise Intervention
Participate in walking and/or strengthening program

Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Completion Rate [ Time Frame: Up to 7 months after baseline ]
    With a true completion rate of 60%, a sample size of 50 for Arm 1, 3 and 4 will yield a 90% confidence interval with its limits extending 0.114 from the observed rate. Therefore, if 23 subjects or fewer complete the intervention, researchers will declare that study arm (i.e., Arm 1, 3 and 4) to be infeasible. For Arm 2, with a true completion rate of 60%, a sample size of 75 will yield a 90% confidence interval with its limits extending 0.093 from the observed rate. Therefore, if 37 subjects or fewer complete the intervention, researchers will declare Arm 2 to be infeasible.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
  • Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)
  • Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)
  • Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)
  • Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1)
  • Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3)
  • History of any cancer, other than non-melanoma skin cancer (Arm 4)
  • Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)
  • Has a valid home address and functioning home telephone number (Arm 4)
  • Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4)
  • Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
  • Fluent in English (PCS study)
  • Must have telephone access and agree to engage with research personnel using telephone (PCS study)

Exclusion Criteria:

  • Major surgery in the past 8 weeks (Arms 1 and 4)
  • Self-reports hypertension that is not being monitored by a physician and is not being managed with either medication, observation, or lifestyle change (Pre-pilot phase, Arms 1-3)
  • Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4)
  • Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2)
  • Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
  • Zubrod performance status > 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3)
  • Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: the study does not exclude those receiving treatment for non-melanoma skin cancer) (Arms 2 and 3)
  • History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
  • Active substance use disorder (diagnosed or strongly suspected) (Arm 4)
  • Currently enrolled in protocol 2014-0712 (PCS study)
  • No home access to internet (PCS study)
  • No home WiFi connection (PCS study)
  • During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
  • Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study)
  • Poorly-controlled pain with a self-reported pain score of 7/10 at the time of enrollment (PCS study)
  • Myopathic or rheumatologic disease that impacts physical function (PCS study)
  • Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365169


Contacts
Contact: Susan Peterson 713-792-8267 speterso@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Susan K. Peterson    713-792-8267      
Principal Investigator: Susan K. Peterson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Peterson M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01365169     History of Changes
Other Study ID Numbers: 2010-0955
NCI-2014-02468 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2010-0955 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01CA177996 ( U.S. NIH Grant/Contract )
RC2CA148263 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Salivary Gland Neoplasms
Head and Neck Neoplasms
Laryngeal Neoplasms
Mouth Neoplasms
Neoplasms, Second Primary
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Mouth Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Carcinoma
Adenocarcinoma
Carcinoma, Neuroendocrine
Pancreatic Cyst
Carcinoma, Islet Cell