Psychosocial Effects of Cancer and Its TreatmentNCT00769249
Positive Changes in Quality of Life of Older Cancer Patients and Their Caregivers
An observational study of Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center.
Trial summary
RATIONALE: Gathering information about the positive changes in quality of life of older patients with cancer and their care givers may help doctors learn more about the disease and plan better treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- questionnaire administration, study of socioeconomic and demographic variables and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
DISEASE CHARACTERISTICS:
- Patient must meet the following criteria:
- Confirmed cancer of any type
- Currently receiving medical care at the Ireland Cancer Center at University Hospitals of Cleveland
- Must have enrolled and participated in CASE-8Z05
- Identified available family caregiver of a patient diagnosed with stage III or IV cancer
PATIENT CHARACTERISTICS:
- Patients must meet the following criteria:
- ECOG performance status 0-3
- Cognitively competent to be interviewed
- Able to speak and comprehend English
- Caregivers must be able to speak and comprehend English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Correlates of Post-Traumatic Growth in Cancer Patients and Their Partners
RATIONALE: Gathering information about the positive changes in quality of life of older patients with cancer and their care givers may help doctors learn more about the disease and plan better treatment.
PURPOSE: This research study is looking at positive changes in the quality of life of older cancer patients and their caregivers.
Read the detailed description
OBJECTIVES:
Primary
- To use prior data from an existing registry (Quality of Life Survey Registry for Persons With Cancer and Family Caregivers protocol CASE-8Z05) and to expand upon these data by adding measures that capture the particularly salient concepts of the patient/caregiver dyadic relationship and posttraumatic growth.
- To identify rates and psychosocial correlates of posttraumatic growth among older adult cancer patient/spouse or partner dyads.
OUTLINE: Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- questionnaire administration, study of socioeconomic and demographic variables, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
study of socioeconomic and demographic variablesOther
Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
psychosocial assessment and careProcedure or surgery
Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of posttraumatic growth
Measured: after diagnosis of cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial Effects of Cancer and Its TreatmentStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- T.J. McCallum, PhD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769249
- Sponsor's protocol ID
- CASE8Z07
- Other IDs
- P30CA043703, CASE8Z07
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2008
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates of Post-Traumatic Growth in Cancer Patients and Their Partners
- ClinicalTrials.gov ID
- NCT00769249
- Acronym / sponsor ID
- CASE8Z07
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 9 Oct 2008 (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: Gathering information about the positive changes in quality of life of older patients with cancer and their care givers may help doctors learn more about the disease and plan better treatment.
PURPOSE: This research study is looking at positive changes in the quality of life of older cancer patients and their caregivers.
Detailed description
OBJECTIVES:
Primary
- To use prior data from an existing registry (Quality of Life Survey Registry for Persons With Cancer and Family Caregivers protocol CASE-8Z05) and to expand upon these data by adding measures that capture the particularly salient concepts of the patient/caregiver dyadic relationship and posttraumatic growth.
- To identify rates and psychosocial correlates of posttraumatic growth among older adult cancer patient/spouse or partner dyads.
OUTLINE: Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
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 administrationPatients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders. | Other | – |
| study of socioeconomic and demographic variablesPatients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders. | Other | – |
| psychosocial assessment and carePatients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders. | Procedure or surgery | – |
Primary outcome
Rate of posttraumatic growth
Time frame: after diagnosis of cancer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
Related trials for Psychosocial Effects of Cancer and Its Treatment
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Assessment Tool for Older Patients With Cancer
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RecruitingObservational study
Fit to Fight Childhood Cancer
Pediatric Oncology
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.
T.J. McCallum, PhD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of posttraumatic growth (time frame: after diagnosis of cancer). 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 19 Mar 2015.