Lung CancerNCT00967083
Support Needs and Preferences of Family Caregivers of Lung Cancer Patients
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
This study is being done to learn what the needs are in relation to the family members. Some family members seek counseling; others do not. The institution wants to try to understand why and wants to see if they can improve our support services for family members. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Questionnaires/Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients whose family caregivers may be eligible for this study will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC) or Queens Cancer Center (QCC).
Who may be able to join
- Primary family caregiver identified by a patient who is approximately within 4 to 6 weeks of a new visit to a thoracic clinic and receiving cancer care at Memorial Sloan-Kettering Cancer Center or Queens Cancer Center
- Caregiver is at least 18 years of age.
- Caregiver has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- Clinically meaningful distress defined as a score of 8 or greater on the Anxiety or Depression subscale of the HADS (see Bjelland et al., 2002; Zigmond \& Snaith, 1983).
Who cannot join
- Patients or caregivers exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation
- Patient has lung cancer recurrence
- Currently participating in a psychosocial intervention trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study is being done to learn what the needs are in relation to the family members. Some family members seek counseling; others do not. The institution wants to try to understand why and wants to see if they can improve our support services for family members.
- Conditions
- Lung Cancer
- Being tested
- Questionnaires/Interviews
- Keywords
- Quality of Life, Questionnaires, Interviews, family members, care givers, 09-104
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires/InterviewsBehavioural
Baseline assessment of distressed caregivers within 4-6 weeks a new visit to the thoracic clinic. Three-month follow-up assessment of caregivers. Qualitative phone interviews with a subsample of 30 caregivers within 3 weeks of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| family caregivers of lung cancer patients | In this 2-year pilot study, we plan to screen family caregivers of lung cancer patients within 4 to 6 weeks after the a new visit to the thoracic clinic. We will screen spouses, adult children, and other family members using the HAD-18 to determine their level of anxiety and depressive symptoms at enrollment. Receives: Behavioral: Questionnaires/Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess psychosocial info & practical needs of prim family caregivers of lung cancer pts.Mental health (anxiety & depression)& behavioral health needs(smoking cessation,alcohol abuse)will be assessed b/c these 2 types of needs are strongly correlate
Measured: 13 to 16 weeks
Secondary outcomes (3)
To assess psychosocial and practical barriers to psychosocial support service use among primary family caregivers of lung cancer patients
Measured: 13 to 16 weeks
To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions.
Measured: 13 to 16 weeks
To gather descriptive information regarding participant flow for planning future intervention studies.
Measured: 13 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Queens Cancer Center of Queens Hospital, Michigan State University, National Cancer Institute (NCI), Indiana University
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967083
- Sponsor's protocol ID
- 09-104
- Status last verified
- Dec 2014
- First submitted
- 26 Aug 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Needs and Preferences of Family Caregivers of Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00967083
- Acronym / sponsor ID
- 09-104
- Conditions
- Lung Cancer
- Keywords
- Quality of Life, Questionnaires, Interviews, family members, care givers, 09-104
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Queens Cancer Center of Queens Hospital, Michigan State University, National Cancer Institute (NCI), Indiana University
- Study start
- Aug 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Aug 2009 (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.
This study is being done to learn what the needs are in relation to the family members. Some family members seek counseling; others do not. The institution wants to try to understand why and wants to see if they can improve our support services for family members.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| family caregivers of lung cancer patients | – | Behavioral: Questionnaires/InterviewsIn this 2-year pilot study, we plan to screen family caregivers of lung cancer patients within 4 to 6 weeks after the a new visit to the thoracic clinic. We will screen spouses, adult children, and other family members using the HAD-18 to determine their level of anxiety and depressive symptoms at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose family caregivers may be eligible for this study will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC) or Queens Cancer Center (QCC).
Key inclusion criteria (4 listed)
- Primary family caregiver identified by a patient who is approximately within 4 to 6 weeks of a new visit to a thoracic clinic and receiving cancer care at Memorial Sloan-Kettering Cancer Center or Queens Cancer Center
- Caregiver is at least 18 years of age.
- Caregiver has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- Clinically meaningful distress defined as a score of 8 or greater on the Anxiety or Depression subscale of the HADS (see Bjelland et al., 2002; Zigmond \& Snaith, 1983).
Key exclusion criteria (3 listed)
- Patients or caregivers exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation
- Patient has lung cancer recurrence
- Currently participating in a psychosocial intervention trial
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 |
|---|---|---|
| Questionnaires/InterviewsBaseline assessment of distressed caregivers within 4-6 weeks a new visit to the thoracic clinic. Three-month follow-up assessment of caregivers. Qualitative phone interviews with a subsample of 30 caregivers within 3 weeks of follow-up. | Behavioural | family caregivers of lung cancer patients |
Primary outcome
Assess psychosocial info & practical needs of prim family caregivers of lung cancer pts.Mental health (anxiety & depression)& behavioral health needs(smoking cessation,alcohol abuse)will be assessed b/c these 2 types of needs are strongly correlate
Time frame: 13 to 16 weeks
3 secondary outcomes
To assess psychosocial and practical barriers to psychosocial support service use among primary family caregivers of lung cancer patients
Time frame: 13 to 16 weeks
To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions.
Time frame: 13 to 16 weeks
To gather descriptive information regarding participant flow for planning future intervention studies.
Time frame: 13 to 16 weeks
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 11 Dec 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 2 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 4 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Assess psychosocial info & practical needs of prim family caregivers of lung cancer pts.Mental health (anxiety & depression)& behavioral health needs(smoking cessation,alcohol abuse)will be assessed b/c these 2 types of needs are strongly correlate (time frame: 13 to 16 weeks). 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 11 Dec 2014.