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

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00756795

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
Head and Neck Cancer	Behavioral: Intervention group

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Depression Head and Neck Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Depression Score [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Fatigue Score [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
Plasma IL-6 Concentration [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	February 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Attention Control: Experimental 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.

Arms

Assigned Interventions

Attention Control: Experimental

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756795

Contacts

Contact: Alvin G Wee, DDS, MS, MPH	402-559-3910	awee@unmc.edu
Contact: Lisa Stamm, BS	402-559-7992	lstamm@unmc.edu

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

No publications provided

Responsible Party:	University of Nebraska Medical Center ( Alvin Gerard Wee )
Study ID Numbers:	053-08
Study First Received:	September 18, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00756795 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009