Breast Cancer Clinical Trial
Official title:
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.
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Observational Model: Cohort, Time Perspective: Prospective
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