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

NCT00756795 | Withdrawn

• 1 other identifier: 0053-08-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life. This study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Self-report of physical activity behavior (duration, intensity and frequency)

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

  Baseline and Post Intervention

Secondary Outcomes (1)

• Plasma IL-6 Concentration

  Baseline and Post Intervention

Study Arms (1)

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

Interventions

Intervention group BEHAVIORAL

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.

Also known as: Digi-Walker ™ Pedometer: SW-701

Attention Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Alvin G Wee

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: April 24, 2008
• Primary Completion: August 5, 2010
• Study Completion: August 5, 2010
• Last Updated: September 23, 2024

Record last verified: 2024-09