Head & Neck Cancer Survivorship: Physical and Functional Status

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT00751816

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

7.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	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

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 Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Head & Neck Cancer Survivorship: Physical and Functional Status

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Supportive Care head and neck cancer survivors who are undergoing chemotherapy and radiation therapy	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: adjuvant therapy Other Names: none noted Procedure: management of therapy complications 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 Radiation: radiation therapy Other Names: none noted

Arm

Intervention/Treatment

Supportive Care

head and neck cancer survivors who are undergoing chemotherapy and radiation therapy

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: adjuvant therapy

Other Names:

none noted

Procedure: management of therapy complications

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

Radiation: radiation therapy

Other Names:

none noted

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838