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

September 7, 2012 updated by: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Family members of a patient with cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supportive
Other: questionnaire administration
no intervention
Other: survey administration
no intervention
Procedure: quality-of-life assessment
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preliminary validation of a family quality of life questionnaire
Time Frame: Off study date
Off study date
Generation of an initial item pool (step 1)
Time Frame: Off study date
Off study date
Reduction of the item pool based on content validity assessment (step 2)
Time Frame: Off study date
Off study date
Psychometric properties and dimensionality of the measure (step 3)
Time Frame: Off study date
Off study date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 13, 2007

First Submitted That Met QC Criteria

October 13, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC SUPP 0737
  • VU-VICC-SUPP-0737
  • VU-VICC-IRB-IRB-070598

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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