Head & Neck Cancer Survivorship: Physical and Functional Status

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00751816
First received: September 11, 2008
Last updated: January 3, 2011
Last verified: January 2011

September 11, 2008
January 3, 2011
June 2008
February 2009   (final data collection date for primary outcome measure)
  • Physical and functional well-being during adjuvant chemoradiotherapy [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]
  • Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]
  • Feasibility of an early physical therapy intervention [ Time Frame: 2 weeks after completing treatment ] [ Designated as safety issue: No ]
  • Physical and functional well-being during adjuvant chemoradiotherapy [ Designated as safety issue: No ]
  • Range of motion for the cervical spine and shoulder during adjuvant chemoradiotherapy [ Designated as safety issue: No ]
  • Feasibility of an early physical therapy intervention [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00751816 on ClinicalTrials.gov Archive Site
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Head & Neck Cancer Survivorship: Physical and Functional Status
Head & Neck Cancer Survivorship: Physical and Functional Status

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Head and Neck Cancer Patients

Head and Neck Cancer
  • Drug: systemic chemotherapy
    Not specified
    Other Name: 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 Name: none noted
  • Procedure: adjuvant therapy
    not specified
    Other Name: none noted
  • Procedure: management of therapy complications
    not specified
    Other Name: None noted
  • Procedure: musculoskeletal complications management/prevention
    Not specified
    Other Name: none noted
  • Procedure: physical therapy
    weekly visits coordinated with adjuvant treatment as part of standard care
    Other Name: none noted
  • Radiation: radiation therapy
    not specified
    Other Name: none noted
Supportive Care
Interventions:
  • Drug: systemic chemotherapy
  • Other: survey administration
  • Procedure: adjuvant therapy
  • Procedure: management of therapy complications
  • Procedure: musculoskeletal complications management/prevention
  • Procedure: physical therapy
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
June 2014
February 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00751816
CDR0000613863, VU-VICC-SUPP-0843
No
Ann Marie Flores, Ph.D., Vanderbilt-Ingram Cancer Center
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Ann Marie Flores, Ph.D. Vanderbilt-Ingram Cancer Center
Vanderbilt University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP