Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)NCT01685346
Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
A study testing biofeedback-mediated stress management (BFSM) in people with Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC), run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a pilot study to test the hypothesis that biofeedback-mediated stress management (BFSM) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- biofeedback-mediated stress management (BFSM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a new diagnosis of advanced (stage IV) non-small cell lung cancer (NSCLC)
- ECOG performance status 0-1.
- Plan to receive care at the Taussig Cancer Center.
Who cannot join
- Non-local patients, who will not have the ability to return for 8 study visits.
- Patients who are unable to speak and understand English readily,
- Patients with significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
This is a pilot study to test the hypothesis that biofeedback-mediated stress management (BFSM) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant physical symptoms, but even those who do not have physical symptoms have high levels of anxiety and depression.
Read the detailed description
Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the reactions which their own bodies have to stressful situations (increased heart rate, increased skin conductance, increased muscle tension, decreased digital peripheral temperature, decreased heart rate variability) and then teaching them to control these reactions, using standard stress management and relaxation techniques, coupled with computerized physiological feedback. The feedback helps patients to understand that deep relaxation is helping their bodies as well as their minds. Several small studies of BFSM training in cancer populations have been successful at helping with side effects of chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL), particularly in NSCLC patients, have not been studied.
- Being tested
- biofeedback-mediated stress management (BFSM)
- Keywords
- advanced (stage IV) non-small cell lung cancer (NSCLC), biofeedback-mediated stress management (BFSM)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback-mediated stress management (BFSM)Behavioural
Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | biofeedback-mediated stress management (BFSM) Receives: Behavioral: biofeedback-mediated stress management (BFSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that are able to return for eight visits of BFSM
Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.
Measured: 16 weeks
Secondary outcomes (10)
Number of patients able to complete the Quality of Life (QOL) questionnaires
Measured: 16 weeks
Assess changes in distress thermometer from baseline
Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.
Measured: 16 weeks
Change from baseline on the FACT-lung questionnaire
Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.
Measured: 16 weeks
Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
Questionnaire to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data.
Measured: 16 weeks
Change from baseline of the Patient Health Questionnaire (PHQ-*8)
8-Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.
Measured: 16 weeks
Change in baseline of digital peripheral temperature
Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
Measured: 16 weeks
Change in baseline of skin conductance
Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
Measured: 16 weeks
Change from baseline of Electromyography (EMG)
Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
Measured: 16 weeks
Change from baseline of respiratory rates
Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
Measured: 16 weeks
Change from baseline of heart rates
Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Research Cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Pennell, MD, Principal investigator, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685346
- Sponsor's protocol ID
- CASE6512
- Other IDs
- 12-874
- Status last verified
- Jul 2015
- First submitted
- 10 Sep 2012
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT01685346
- Acronym / sponsor ID
- CASE6512
- Keywords
- advanced (stage IV) non-small cell lung cancer (NSCLC), biofeedback-mediated stress management (BFSM)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research Cancelled
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Sep 2012 (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 is a pilot study to test the hypothesis that biofeedback-mediated stress management (BFSM) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant physical symptoms, but even those who do not have physical symptoms have high levels of anxiety and depression.
Detailed description
Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the reactions which their own bodies have to stressful situations (increased heart rate, increased skin conductance, increased muscle tension, decreased digital peripheral temperature, decreased heart rate variability) and then teaching them to control these reactions, using standard stress management and relaxation techniques, coupled with computerized physiological feedback. The feedback helps patients to understand that deep relaxation is helping their bodies as well as their minds. Several small studies of BFSM training in cancer populations have been successful at helping with side effects of chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL), particularly in NSCLC patients, have not been studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: biofeedback-mediated stress management (BFSM)biofeedback-mediated stress management (BFSM) |
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 with a new diagnosis of advanced (stage IV) non-small cell lung cancer (NSCLC)
- ECOG performance status 0-1.
- Plan to receive care at the Taussig Cancer Center.
Key exclusion criteria (3 listed)
- Non-local patients, who will not have the ability to return for 8 study visits.
- Patients who are unable to speak and understand English readily,
- Patients with significant cognitive impairment.
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 |
|---|---|---|
| biofeedback-mediated stress management (BFSM)Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs. | Behavioural | Biofeedback |
Primary outcome
Number of patients that are able to return for eight visits of BFSM
Time frame: 16 weeks
Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.
10 secondary outcomes
Number of patients able to complete the Quality of Life (QOL) questionnaires
Time frame: 16 weeks
Assess changes in distress thermometer from baseline
Time frame: 16 weeks
Change from baseline on the FACT-lung questionnaire
Time frame: 16 weeks
Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
Time frame: 16 weeks
Change from baseline of the Patient Health Questionnaire (PHQ-*8)
Time frame: 16 weeks
Change in baseline of digital peripheral temperature
Time frame: 16 weeks
Change in baseline of skin conductance
Time frame: 16 weeks
Change from baseline of Electromyography (EMG)
Time frame: 16 weeks
Change from baseline of respiratory rates
Time frame: 16 weeks
Change from baseline of heart rates
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Research Cancelled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
Nathan Pennell, MD principal investigator
Cleveland Clinic Taussig Cancer Center, 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 biofeedback-mediated stress management (BFSM) in people with Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC), 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 3 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 10 Jul 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: Research Cancelled). 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?
Number of patients that are able to return for eight visits of BFSM (time frame: 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 10 Jul 2015.