Clinical trial NCT00544336: Family Quality of Life Among Families With a Member Who is a Cancer Patient
Official title: Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Head and Neck Cancer
Lung Cancer
Prostate Cancer
Solid Tumor
Keywords: unspecified adult solid tumor, protocol specific
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent non-small cell lung cancer
recurrent small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent squamous cell carcinoma of the lip and oral cavity
stage I basal cell carcinoma of the lip
stage II basal cell carcinoma of the lip
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
untreated metastatic squamous neck cancer with occult primary
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
high-grade salivary gland mucoepidermoid carcinoma
low-grade salivary gland mucoepidermoid carcinoma
recurrent salivary gland cancer
salivary gland acinic cell tumor
salivary gland adenocarcinoma
salivary gland adenoid cystic carcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland poorly differentiated carcinoma
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-16
Enrollment: 366
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Family members of a patient with cancer

Brief summary: RATIONALE: Developing a questionnaire that can be used to assess the quality of life among people who have a family member with cancer may help the study of cancer in the future.

PURPOSE: This clinical trial is studying quality of life among families with a member who is a cancer patient.

Detailed description: OBJECTIVES:

* Develop and conduct preliminary validation of a Family Quality of Life Questionnaire for use with families with an adult cancer patient, with the measure appropriate for use for both research and clinical assessment purposes.
* Generate an initial item pool for the measure (step 1).
* Reduce the item pool based on a content validity assessment (step 2).
* Assess the psychometric properties and dimensionality of the measure (step 3).

OUTLINE:

* Step 1 (item generation): Items are generated through a literature review and a semi-structured interview with patients and their families. The purposes of the interview are to determine whether the five domains identified in the literature review (family interaction, family roles, family communication, family emotional support, overall family quality of life \[FQOL\]) are central areas of FQOL, and to determine if there are other important FQOL domains affected by cancer and its treatment. Patients and their family members are interviewed individually over 45-60 minutes. The initial item pool is generated based on the literature review and interviews.
* Step 2 (item review and reduction): The initial item pool is examined and reduced based on its content validity. Ten health care providers with a minimum of five years experience working with cancer patients rate the content validity of the proposed questionnaire. Experts receive a packet of questionnaires, including the objective of the study, the proposed questionnaire as developed in step 1, and the proposed questionnaire with its format modified for the examination of content validity. The content validity version uses a 4-point Likert format to assess each item's relevance, sufficiency (i.e., the extent to which it fully covers its intended domain) and clarity in relation to the construct (FQOL domain) that it is supposed to assess. Experts are asked to rate the overall format of the questionnaire in regards to ease of use and appropriateness, and for open-ended comments or suggestions. Items are modified or dropped based on the experts' review.
* Step 3 (final item selection and psychometric evaluation): Patients and family members complete the FQOL questionnaire developed in previous steps and other questionnaires with proven reliability and validity at baseline. Other questionnaires include the SF-36 (general QOL survey that is used widely in general population samples and patients, including cancer patients), the FACT-G for patients (instrument used to assess health-related QOL in cancer patients), with the version of the FACT-G modified by Northouse for the family member, the Family Interaction and Emotional Well-Being subscales (to examine family interaction and family emotional support of cancer families) of the Beach Center Family Quality of Life Scale (FQOL measure for families with a disabled child), the Balanced Cohesion subscale (to examine family interaction of cancer families) of the FACES IV (that assesses balanced and unbalanced family cohesion and family flexibility in general population), and the Family Communication Scale (a general survey used to assess family communication in the general population). Patients and family members complete the FQOL again 2 weeks after the initial assessment.

PROJECTED ACCRUAL: Approximately 210 cancer patients and 210 family members will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with any local, advanced, or metastatic cancer that has required more than a simple surgical procedure

  * Ten families with an adult patient with breast, prostate, lung, colon, or head and neck cancer are interviewed for step 1 portion of the study
* An available adult family member willing to participate in the study

  * The term family is defined broadly to include adults over 21 years of age, considered by the cancer patient as a family member, who provides care or support and/or shares the cancer experience with the patient
  * Family members do not need to be biologically related to the patient or related through marriage, and may or may not live in the same house with the patient

Exclusion Criteria:

* Able to read, write, and speak English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Preliminary validation of a family quality of life questionnaire
timeFrame: Off study date
measure: Generation of an initial item pool (step 1)
timeFrame: Off study date
measure: Reduction of the item pool based on content validity assessment (step 2)
timeFrame: Off study date
measure: Psychometric properties and dimensionality of the measure (step 3)
timeFrame: Off study date
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: