Breast CancerNCT00544336
Family Quality of Life Among Families With a Member Who is a Cancer Patient
An observational study of Breast Cancer and Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- questionnaire administration, survey administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 366 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Family members of a patient with cancer
Who may be able to join
- 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
Who cannot join
- Able to read, write, and speak English
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Solid Tumor
- Being tested
- questionnaire administration, survey administration, quality-of-life assessment
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
no intervention
survey administrationOther
no intervention
quality-of-life assessmentProcedure or surgery
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Supportive | Not described Receives: Other: questionnaire administration; Other: survey administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary validation of a family quality of life questionnaire
Measured: Off study date
Generation of an initial item pool (step 1)
Measured: Off study date
Reduction of the item pool based on content validity assessment (step 2)
Measured: Off study date
Psychometric properties and dimensionality of the measure (step 3)
Measured: Off study date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara Murphy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544336
- Sponsor's protocol ID
- VICC SUPP 0737
- Other IDs
- VU-VICC-SUPP-0737, VU-VICC-IRB-IRB-070598
- Status last verified
- Sep 2012
- First submitted
- 13 Oct 2007
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Family Quality of Life Among Families With a Member Who is a Cancer Patient
- ClinicalTrials.gov ID
- NCT00544336
- Acronym / sponsor ID
- VICC SUPP 0737
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Solid Tumor
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive | – | Other: questionnaire administration, Other: survey administration, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Family members of a patient with cancer
Key inclusion criteria (5 listed)
- Patients diagnosed with any local, advanced, or metastatic cancer that has required more than a simple surgical procedure
- An available adult family member willing to participate in the study
Key exclusion criteria (3 listed)
- Able to read, write, and speak English
- See Disease Characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationno intervention | Other | Supportive |
| survey administrationno intervention | Other | Supportive |
| quality-of-life assessmentno intervention | Procedure or surgery | Supportive |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Murphy, MD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary validation of a family quality of life questionnaire (time frame: Off study date). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.