Family Quality of Life Among Families With a Member Who is a Cancer Patient

Breast Cancer Clinical Trial

Official title:

Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544336
• Other study ID #: VICC SUPP 0737
• Secondary ID: VU-VICC-SUPP-073
• Status: Completed
• Phase: N/A
• First received: October 13, 2007
• Last updated: September 7, 2012
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Vanderbilt University Human Research Protection Program
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Solid Tumor

Intervention

Other:
• questionnaire administration
no intervention
• survey administration
no intervention

Procedure:
• quality-of-life assessment
no intervention

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary validation of a family quality of life questionnaire		Off study date	No
Primary	Generation of an initial item pool (step 1)		Off study date	No
Primary	Reduction of the item pool based on content validity assessment (step 2)		Off study date	No
Primary	Psychometric properties and dimensionality of the measure (step 3)		Off study date	No