Head and Neck CancerI-PAPNCT00756795
Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
A study testing Intervention group in people with Head and Neck Cancer, run by University of Nebraska.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2008to 5 Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Intervention group
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Also called Digi-Walker ™ Pedometer: SW-701
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Post Intervention
Secondary outcomes (1)
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.
Measured: Baseline and Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study start24 Apr 2008
- Primary completion5 Aug 2010
- Study completion5 Aug 2010
Why it stopped: PI chose not to continue with this unfunded study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvin G Wee, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756795
- Sponsor's protocol ID
- 0053-08-FB
- Acronym
- I-PAP
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2008
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
- ClinicalTrials.gov ID
- NCT00756795
- Acronym / sponsor ID
- I-PAP / 0053-08-FB
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI chose not to continue with this unfunded study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 24 Apr 2008 (actual)
- Primary completion
- 5 Aug 2010 (actual)
- Study completion
- 5 Aug 2010 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Experimental | Behavioral: Intervention group5ml 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupAlso: Digi-Walker ™ Pedometer: SW-7015ml 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. | Behavioural | Attention Control |
Primary outcome
Self-report of physical activity behavior (duration, intensity and frequency)
Time frame: Baseline and Post Intervention
Participants will be taught how to keep the Activity diary to record walking and physical activities.
1 secondary outcome
Plasma IL-6 Concentration
Time frame: Baseline and Post Intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvin G Wee principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Head and Neck Cancer, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of physical activity behavior (duration, intensity and frequency) (time frame: Baseline and Post Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.