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

Primary Purpose

Head and Neck Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intervention group

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Attention Control

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Plasma IL-6 Concentration

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

Full Information

NCT ID

NCT00756795

First Posted

September 18, 2008

Last Updated

August 11, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT00756795

Brief Title

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

Acronym

I-PAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

PI chose not to continue with this unfunded study

Study Start Date

April 24, 2008 (Actual)

Primary Completion Date

August 5, 2010 (Actual)

Study Completion Date

August 5, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Attention Control

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Intervention group

Other Intervention Name(s)

Digi-Walker ™ Pedometer: SW-701

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline and Post Intervention

Secondary Outcome Measure Information:

Title

Plasma IL-6 Concentration

Description

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

Time Frame

Baseline and Post Intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alvin G Wee

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

12. IPD Sharing Statement

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

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