Head & Neck Cancer Survivorship: Physical and Functional Status

December 8, 2015 updated by: Vanderbilt University

RATIONALE: Early physical therapy may be effective in improving range of motion of the neck and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation therapy.

PURPOSE: This phase I trial is studying how well early physical therapy works in improving physical and functional well-being in head and neck cancer survivors receiving chemoradiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Describe the physical and functional well-being of head and neck cancer (HNC) survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  • Describe clinical measure of range of motion for the cervical spine and shoulder of HNC survivors undergoing physical therapy during adjuvant chemoradiotherapy.
  • Determine the feasibility of an early physical therapy intervention (prior to and during adjuvant treatment) targeting the physical needs of HNC survivors.

OUTLINE: Patients undergo physical therapy weekly for 10 weeks beginning 1 week prior to initiating adjuvant chemoradiotherapy and continuing until 2 weeks after the completion of adjuvant chemoradiotherapy.

Patients undergo range of motion assessment and complete a Cancer Survivorship Survey (CSS) at baseline and in weeks 4, 8, 9, and 10 of physical therapy.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Head and Neck Cancer Patients

Description

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Head and neck cancer survivor

  • Planning to receive adjuvant chemoradiotherapy for head and neck cancer

    • Has not yet initiated adjuvant therapy
  • Referred to rehabilitation oncology physical therapy program

Exclusion Criteria:

  • No metastatic disease
  • No CNS cancer

PATIENT CHARACTERISTICS:

  • Speaks English
  • No significant history of cardiovascular or neurovascular disease involving disability

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Not currently in hospice care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supportive Care
head and neck cancer survivors who are undergoing chemotherapy and radiation therapy
Radiation: radiation therapy
Other Names:
  • none noted
Procedure: adjuvant therapy
Other Names:
  • none noted
Procedure: management of therapy complications
Other Names:
  • None noted
Drug: systemic chemotherapy
Other Names:
  • none noted
Other: survey administration
will be administered before, during, and after medical intent-to-cure treatment to describe head and neck cancer survivors' physical and functional well-being.
Other Names:
  • none noted
Procedure: musculoskeletal complications management/prevention
Other Names:
  • none noted
Procedure: physical therapy
weekly visits coordinated with adjuvant treatment as part of standard care
Other Names:
  • none noted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical and functional well-being during adjuvant chemoradiotherapy
Time Frame: 2 weeks after completing treatment
2 weeks after completing treatment
Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy
Time Frame: 2 weeks after completing treatment
2 weeks after completing treatment
Feasibility of an early physical therapy intervention
Time Frame: 2 weeks after completing treatment
2 weeks after completing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ann Marie Flores, Ph.D., Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000613863
  • VU-VICC-SUPP-0843

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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