AgingA&SCNCT00106067
Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients
A study testing coping and communication support (CCS) intervention in people with Aging and Neoplasms, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- coping and communication support (CCS) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2008
- Phase
- Interventional
- 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
Who may be able to join
- Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
- Patients must be cognitively intact at time of enrollment.
- Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.
Who cannot join
- Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
About this study
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.
Read the detailed description
We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
- Being tested
- coping and communication support (CCS) intervention
- Keywords
- aging, behavioral research, quality of life, end of life, family relations, supportive care, advanced care, bereavement
- Medical subject headings
- Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coping and communication support (CCS) interventionBehavioural
Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.
The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site. Receives: Behavioral: coping and communication support (CCS) intervention |
| Arm 2 | No intervention | In the control arm, Patients are receiving the usual care in the site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
Measured: one year
Secondary outcomes (1)
To assess the efficacy of the intervention among patients in coping and decisions around end of life.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2005 (estimated)
- Study startJun 2004
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia Rose, PhD MA, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106067
- Sponsor's protocol ID
- IIR 03-255
- Acronym
- A&SC
- Status last verified
- Apr 2009
- First submitted
- 18 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bowman KF, Rose JH, Radziewicz RM, O'Toole EE, Berila RA. Family caregiver engagement in a coping and communication support intervention tailored to advanced cancer patients and families. Cancer Nurs. 2009 Jan-Feb;32(1):73-81. doi: 10.1097/01.NCC.0000343367.98623.83.
PubMed 19104204Rose JH, Radziewicz R, Bowmans KF, O'Toole EE. A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Clin Interv Aging. 2008;3(1):77-95. doi: 10.2147/cia.s1262.
PubMed 18488881Rose JH, O'Toole EE, Einstadter D, Love TE, Shenko CA, Dawson NV. Patient age, well-being, perspectives, and care practices in the early treatment phase for late-stage cancer. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):960-8. doi: 10.1093/gerona/63.9.960.
PubMed 18840801
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00106067
- Acronym / sponsor ID
- A&SC / IIR 03-255
- Keywords
- aging, behavioral research, quality of life, end of life, family relations, supportive care, advanced care, bereavement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Mar 2005 (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.
The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.
Detailed description
We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: coping and communication support (CCS) interventionIn the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site. |
| Arm 2 | No intervention | –In the control arm, Patients are receiving the usual care in the site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed within 1 year with advanced cancer (stage IV), aged 40 years or older.
- Patients must be cognitively intact at time of enrollment.
- Patient need not have family care-giver to be enrolled, but if there is one, FCG is enrolled with the patient. FCG need not be 40 years of age.
Key exclusion criteria (1 listed)
- Less than stage IV cancer, stage IV cancer diagnosed over 1 year previously or younger than 40 years of age.
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 |
|---|---|---|
| coping and communication support (CCS) interventionTrained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families. | Behavioural | Arm 1 |
Primary outcome
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.
Time frame: one year
1 secondary outcome
To assess the efficacy of the intervention among patients in coping and decisions around end of life.
Time frame: two years
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 7 Apr 2015.
- Results publication: PubMed 19104204Bowman KF, Rose JH, Radziewicz RM, O'Toole EE, Berila RA. Family caregiver engagement in a coping and communication support intervention tailored to advanced cancer patients and families. Cancer Nurs. 2009 Jan-Feb;32(1):73-81. doi: 10.1097/01.NCC.0000343367.98623.83.
- Results publication: PubMed 18488881Rose JH, Radziewicz R, Bowmans KF, O'Toole EE. A coping and communication support intervention tailored to older patients diagnosed with late-stage cancer. Clin Interv Aging. 2008;3(1):77-95. doi: 10.2147/cia.s1262.
- Results publication: PubMed 18840801Rose JH, O'Toole EE, Einstadter D, Love TE, Shenko CA, Dawson NV. Patient age, well-being, perspectives, and care practices in the early treatment phase for late-stage cancer. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):960-8. doi: 10.1093/gerona/63.9.960.
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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.
Julia Rose, PhD MA principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coping and communication support (CCS) intervention in people with Aging and Neoplasms, run by US Department of Veterans Affairs at 1 site 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 3 inclusion and 1 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106067, which also lists 3 linked publications.
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 7 Apr 2015.