Stage IV Lung CancerNCT02128373
A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
A study testing computer-assisted intervention, Distress Thermometer and Profile of Mood States (POMS-B) in people with Stage IV Lung Cancer and Malignant Brain Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies the feasibility and effectiveness of a new computer-based communication intervention in supporting distance caregivers of patients with advanced lung or brain cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stage IV Lung Cancer, Malignant Brain Tumor
- What is being tested?
- computer-assisted intervention, Distress Thermometer and Profile of Mood States (POMS-B)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a diagnosis of advanced lung cancer or malignant brain tumor for two to six months
- Receiving on-going care from the medical oncologist at the Seidman Cancer Center
- Having a primary and distance caregiver involved in their care, support, and/or care planning
- English as a primary language
- Capacity to provide informed consent, as validated by the oncologist
- Family caregiver of a patient with advanced lung cancer or malignant brain tumor
Show all 10Show fewer
- Patient and distance caregiver perception that this caregiver's geographic location is such that precludes routine participation in medical appointments
- English as primary language
- Capable of providing informed consent
- Computer ownership with internet access
Who cannot join
- No primary caregiver
- Enrolled in hospice
- Those who routinely participate in most of the patient's medical appointments (once or more per month)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
This pilot clinical trial studies the feasibility and effectiveness of a new computer-based communication intervention in supporting distance caregivers of patients with advanced lung or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any, professional support and have limited communication with the oncology team. Using a computer-based communication intervention to allow distance caregivers the opportunity to participate in a physician visit, have questions and concerns addressed, and meet members of the oncology team may help reduce stress.
Read the detailed description
PRIMARY OBJECTIVES:
- What is the relationship of primary stressors (type and stage/grade of cancer, and patient quality of life [QOL]) and structural factors/stressors (age, gender, race, and education) with patient and caregiver psychological outcomes at baseline? II. What are the effects of the Communication with Long Distance Caregivers Offering a Supportive Electronic Resource (CLOSER) intervention on distance caregiver psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? III. What are the effects of the CLOSER intervention on patient psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? IV. What is the feasibility (time, cost, resources and acceptability to patients, caregivers and clinicians) of using Adobe Connect, a computer-based web communication system, with the distance caregiver, the parent with advanced cancer, and the health care providers together in a routine follow-up oncology office visit? V. What is the experience of being a distance caregiver participating in the CLOSER intervention?
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM I: Participants receive usual care for 5 weeks. During the week 5 office visit, distance caregivers are not present.
ARM II: Participants receive usual care for 5 weeks. During the week 5 visit, distance caregivers virtually attend using the CLOSER intervention with computer video and audio connection.
After completion of study, participants are followed up within 48-96 hours.
- Conditions
- Stage IV Lung Cancer, Malignant Brain Tumor
- Being tested
- Usual care, computer-assisted intervention, Distress Thermometer, Profile of Mood States (POMS-B), Quality of Life: Functional Assessment in Cancer Therapy - (FACT)
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careProcedure or surgery
Health care provided by physician, physician's nurse, and social worker
computer-assisted interventionOther
Caregiver will virtually attend visit using the CLOSER intervention
Distress ThermometerOther
Average score of a one item scale (range 0-10) where higher scores indicate more distress
Profile of Mood States (POMS-B)Other
average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
Quality of Life: Functional Assessment in Cancer Therapy - (FACT)Other
Average score of FACT which quantitatively assesses brain cancer patient's physiological functional and quality of life. FACT questions are scored 0-4 with higher numbers indicating more functionality
Tension-Anxiety SubscaleOther
six item scale which asks to qualitatively describe which areas in you life are causing stress
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer Receives: Procedure: Usual care; Other: Distress Thermometer; Other: Profile of Mood States (POMS-B); Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT); Other: Tension-Anxiety Subscale |
| Arm II (usual care with CLOSER intervention) | Experimental | Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention Receives: Procedure: Usual care; Other: computer-assisted intervention; Other: Distress Thermometer; Other: Profile of Mood States (POMS-B); Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT); Other: Tension-Anxiety Subscale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary stressors (type and stage/grade of cancer, and patient QOL)
Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).
Measured: Baseline
effect of CLOSER intervention on caregiver anxiety
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention caregiver groups
Measured: Up to 96 hours after week 5 visit
Frequency of technological errors
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Measured: Up to 96 hours after week 5 visit
Length of time of physician office visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Measured: Up to 96 hours after week 5 visit
Perceived ease of use
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Measured: Up to 96 hours after week 5 visit
effect of CLOSER intervention on caregiver distress
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention caregiver groups
Measured: Up to 96 hours after week 5 visit
effect of CLOSER intervention on patient distress
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention patient groups
Measured: Up to 96 hours after week 5 visit
effect of CLOSER intervention on patient anxiety
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention patient groups
Measured: Up to 96 hours after week 5 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 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
- Sara Douglas, RN, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128373
- Sponsor's protocol ID
- CASE3Z11
- Other IDs
- NCI-2014-00812, CASE3Z11, CASE 3Z11, P30CA043703
- Status last verified
- Feb 2015
- First submitted
- 29 Apr 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02128373
- Acronym / sponsor ID
- CASE3Z11
- Conditions
- Stage IV Lung Cancer, Malignant Brain Tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 May 2014 (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 pilot clinical trial studies the feasibility and effectiveness of a new computer-based communication intervention in supporting distance caregivers of patients with advanced lung or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any, professional support and have limited communication with the oncology team. Using a computer-based communication intervention to allow distance caregivers the opportunity to participate in a physician visit, have questions and concerns addressed, and meet members of the oncology team may help reduce stress.
Detailed description
PRIMARY OBJECTIVES:
- What is the relationship of primary stressors (type and stage/grade of cancer, and patient quality of life [QOL]) and structural factors/stressors (age, gender, race, and education) with patient and caregiver psychological outcomes at baseline? II. What are the effects of the Communication with Long Distance Caregivers Offering a Supportive Electronic Resource (CLOSER) intervention on distance caregiver psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? III. What are the effects of the CLOSER intervention on patient psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? IV. What is the feasibility (time, cost, resources and acceptability to patients, caregivers and clinicians) of using Adobe Connect, a computer-based web communication system, with the distance caregiver, the parent with advanced cancer, and the health care providers together in a routine follow-up oncology office visit? V. What is the experience of being a distance caregiver participating in the CLOSER intervention?
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM I: Participants receive usual care for 5 weeks. During the week 5 office visit, distance caregivers are not present.
ARM II: Participants receive usual care for 5 weeks. During the week 5 visit, distance caregivers virtually attend using the CLOSER intervention with computer video and audio connection.
After completion of study, participants are followed up within 48-96 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Procedure: Usual care, Other: Distress Thermometer, Other: Profile of Mood States (POMS-B), Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT), Other: Tension-Anxiety SubscaleParticipants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer |
| Arm II (usual care with CLOSER intervention) | Experimental | Procedure: Usual care, Other: computer-assisted intervention, Other: Distress Thermometer, Other: Profile of Mood States (POMS-B), Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT), Other: Tension-Anxiety SubscaleParticipants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Having a diagnosis of advanced lung cancer or malignant brain tumor for two to six months
- Receiving on-going care from the medical oncologist at the Seidman Cancer Center
- Having a primary and distance caregiver involved in their care, support, and/or care planning
- English as a primary language
- Capacity to provide informed consent, as validated by the oncologist
Key exclusion criteria (3 listed)
- No primary caregiver
- Enrolled in hospice
- Those who routinely participate in most of the patient's medical appointments (once or more per month)
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 |
|---|---|---|
| Usual careHealth care provided by physician, physician's nurse, and social worker | Procedure or surgery | Arm I (usual care), Arm II (usual care with CLOSER intervention) |
| computer-assisted interventionCaregiver will virtually attend visit using the CLOSER intervention | Other | Arm II (usual care with CLOSER intervention) |
| Distress ThermometerAverage score of a one item scale (range 0-10) where higher scores indicate more distress | Other | Arm I (usual care), Arm II (usual care with CLOSER intervention) |
| Profile of Mood States (POMS-B)average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort | Other | Arm I (usual care), Arm II (usual care with CLOSER intervention) |
| Quality of Life: Functional Assessment in Cancer Therapy - (FACT)Average score of FACT which quantitatively assesses brain cancer patient's physiological functional and quality of life. FACT questions are scored 0-4 with higher numbers indicating more functionality | Other | Arm I (usual care), Arm II (usual care with CLOSER intervention) |
| Tension-Anxiety Subscalesix item scale which asks to qualitatively describe which areas in you life are causing stress | Other | Arm I (usual care), Arm II (usual care with CLOSER intervention) |
Primary outcome
Primary stressors (type and stage/grade of cancer, and patient QOL)
Time frame: Baseline
Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).
effect of CLOSER intervention on caregiver anxiety
Time frame: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention caregiver groups
Frequency of technological errors
Time frame: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Length of time of physician office visit
Time frame: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Perceived ease of use
Time frame: Up to 96 hours after week 5 visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
effect of CLOSER intervention on caregiver distress
Time frame: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention caregiver groups
effect of CLOSER intervention on patient distress
Time frame: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention patient groups
effect of CLOSER intervention on patient anxiety
Time frame: Up to 96 hours after week 5 visit
A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention patient groups
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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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.
Sara Douglas, RN, PhD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-assisted intervention, Distress Thermometer and Profile of Mood States (POMS-B) in people with Stage IV Lung Cancer and Malignant Brain Tumor, run by Case Comprehensive Cancer Center 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 10 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: stopped early, as of the sponsor's last update on 18 Feb 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 was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Primary stressors (type and stage/grade of cancer, and patient QOL) (time frame: Baseline). The study lists 8 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 18 Feb 2015.