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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00544336
First received: October 13, 2007
Last updated: September 7, 2012
Last verified: September 2012

October 13, 2007
September 7, 2012
August 2007
February 2009   (final data collection date for primary outcome measure)
  • Preliminary validation of a family quality of life questionnaire [ Time Frame: Off study date ] [ Designated as safety issue: No ]
  • Generation of an initial item pool (step 1) [ Time Frame: Off study date ] [ Designated as safety issue: No ]
  • Reduction of the item pool based on content validity assessment (step 2) [ Time Frame: Off study date ] [ Designated as safety issue: No ]
  • Psychometric properties and dimensionality of the measure (step 3) [ Time Frame: Off study date ] [ Designated as safety issue: No ]
  • Preliminary validation of a family quality of life questionnaire
  • Generation of an initial item pool (step 1)
  • Reduction of the item pool based on content validity assessment (step 2)
  • Psychometric properties and dimensionality of the measure (step 3)
Complete list of historical versions of study NCT00544336 on ClinicalTrials.gov Archive Site
Not Provided
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Family Quality of Life Among Families With a Member Who is a Cancer Patient
Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Family members of a patient with cancer

  • Breast Cancer
  • Colorectal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Prostate Cancer
  • Solid Tumor
  • Other: questionnaire administration
    no intervention
    Other Name: questionnaire administration
  • Other: survey administration
    no intervention
    Other Name: survey administration
  • Procedure: quality-of-life assessment
    no intervention
    Other Name: quality-of-life assessment
Supportive
Interventions:
  • Other: questionnaire administration
  • Other: survey administration
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
May 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00544336
VICC SUPP 0737, VU-VICC-SUPP-0737, VU-VICC-IRB-IRB-070598
Yes
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
September 2012

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