We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study) (I-PAP)

This study has been terminated.
(PI chose not to continue with this unfunded study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756795
First Posted: September 22, 2008
Last Update Posted: September 1, 2010
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. Read our disclaimer for details.
Information provided by:
University of Nebraska
  Purpose

The general hypothesis of this research is that patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Increasing and sustaining physical activity of these patients will improve their emotional well-beings, increase their immunological response, improve wound healing, lessen fatigue and improve their general functionality and quality of life.

The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise intervention program in increasing physical activity in head and neck cancer patients; (2) determine if physically active patients differ in quality of life, depression and fatigue during the course of the study; and (3) determine if the change in physical activity levels is related to changes in the immune responses in human.


Condition Intervention Phase
Head and Neck Cancer Behavioral: Intervention group Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Self-report of physical activity behavior (duration, intensity and frequency) [ Time Frame: Baseline and Post Intervention ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline and Post Intervention ]
  • Depression Score [ Time Frame: Baseline and Post Intervention ]
  • Fatigue Score [ Time Frame: Baseline and Post Intervention ]
  • Plasma IL-6 Concentration [ Time Frame: Baseline and Post Intervention ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Control

5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.

Patient will be taught how to keep the Activity diary to record walking and physical activities.

Structured Interview will be conducted at baseline and post-intervention. All patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis

Behavioral: Intervention group

5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.

Structured Interview will be conducted at baseline and post-intervention.

Patients assigned to the Intervention group will be given pedometers to obtain distance walked. In addition, patient will be taught how to keep the Exercise diary to record walking and physical activities.

All patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis.

Other Name: Digi-Walker ™ Pedometer: SW-701

Detailed Description:
No data to report. No subjects enrolled
  Eligibility

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:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 19 years of age or above (Nebraska legal age).
  2. Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center.
  3. Patients who have undergone chemotherapy, radiation and/or surgery for their cancer.
  4. Patients who have completed their cancer treatment at least 3 months prior.
  5. Patients who have consented to participate in this study with approval by their physicians.
  6. Patients who have no significant mental impairment.

Exclusion Criteria:

  1. Patients who are on enteral feeding.
  2. Patients who are not able to walk or whose surgeons report that walking is not advisable.
  3. Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma.
  4. Patients who are on antidepressant medications.
  5. Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention.
  6. Patients participating in another research study involving a therapeutic intervention.
  7. Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements).
  8. Patients who are at 18 months or more after the start of cancer treatment.
  Contacts and Locations
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): NCT00756795


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Alvin G Wee University of Nebraska
  More Information

Responsible Party: Alvin Gerard Wee, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00756795     History of Changes
Other Study ID Numbers: 053-08
First Submitted: September 18, 2008
First Posted: September 22, 2008
Last Update Posted: September 1, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms