Family Quality of Life Among Families With a Member Who is a Cancer Patient
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00544336|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : September 10, 2012
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Prostate Cancer Solid Tumor||Other: questionnaire administration Other: survey administration Procedure: quality-of-life assessment|
- 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).
- 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.
|Study Type :||Observational|
|Actual Enrollment :||366 participants|
|Official Title:||Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||May 2009|
Other: questionnaire administration
no interventionOther: survey administration
no interventionProcedure: quality-of-life assessment
- Preliminary validation of a family quality of life questionnaire [ Time Frame: Off study date ]
- Generation of an initial item pool (step 1) [ Time Frame: Off study date ]
- Reduction of the item pool based on content validity assessment (step 2) [ Time Frame: Off study date ]
- Psychometric properties and dimensionality of the measure (step 3) [ Time Frame: Off study date ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544336
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center at Franklin|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Barbara Murphy, MD||Vanderbilt-Ingram Cancer Center|