Stage IV Gastrointestinal CancerNCT02842047
The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning
A study testing Stop, Breathe & Think™, End of Life Planning Videos and Caregiver wellness videos in people with Stage IV Gastrointestinal Cancer and Advanced Gynecological Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. 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 Gastrointestinal Cancer, Advanced Gynecological Cancer
- What is being tested?
- Stop, Breathe & Think™, End of Life Planning Videos and Caregiver wellness videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 9 Mar 2018
- 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
- caregivers of patients who have been diagnosed with Stage IV gastrointestinal (GI) cancer
- coming with the patient at the Seidman Comprehensive Cancer Center at University Hospitals Case Medical Center (UHCMC)
- have access to the internet and a computer, tablet, or smart phone, and
- speak and comprehend English.
Who cannot join
- currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
- require psychotherapy within the last three months
- have a history of dementia, major neurological illness
- pregnant
- history of a medical condition or procedure that is contraindicated for functional magnetic resonance imaging (fMRI) scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
- claustrophobia requiring anxiolytics or sedation; or
- expect to relocate from Northeast, Ohio within 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Self-Management of Stress in Caregivers of Cancer Patients
Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. The purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. One group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. Investigators will randomly assign participants to each group.
Read the detailed description
Investigators will conduct a randomized trial pilot study to examine two arms of the intervention among 20 caregivers of patients with advanced cancer. Investigators will collect mixed methods data to describe changes in proximal and distal outcomes. Investigators have chosen the time points to capture neural and behavioral changes associated with the intervention and to capture end of life quality of life (QOL) for a majority of caregivers after death of their loved one. Investigators aim to:
- Evaluate the short and longer-term effects of the end of life care with medication (EOL_M) and meditation only (M_Only) interventions on stress reduction and end of life (EOL) planning behaviors and determine if there are different effects between EOL_M and M_ Only interventions.
- Evaluate the short-term and long-term effects of the intervention on caregiver distress, decisional regret, and EOL values and goals of care for treatment.
- Evaluate the impact of decentering on the association between the interventions, self-management behaviors (stress reduction and EOL planning behaviors) and distress, anxiety, concordance between EOL values and goals of care for treatment, decisional regret and satisfaction with EOL care.
- Describe the neural activity processes that are associated with increased self-management activities.
- Being tested
- Stop, Breathe & Think™, End of Life Planning Videos, Caregiver wellness videos
- Keywords
- caregiver, end of life
- Medical subject headings
- Gastrointestinal Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop, Breathe & Think™Behavioural
Also called meditation app
online daily meditations delivered using smart phone or other computer based application
End of Life Planning VideosBehavioural
Also called online videos
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though key aspects of end of life planning.
Caregiver wellness videosBehavioural
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
| Study group | Role | What they receive |
|---|---|---|
| End of Life Care with Meditation | Experimental | The intervention has two content components: end of life planning education (using end of life planning videos) and strategies and kindness based meditation (using the Stop, Breathe \& Think™ app). The activities comprising these components work together to improve both analytic neural processing (e.g. improving knowledge about goal setting and EOL planning, learning self-monitoring of EOL values and goals of care, and self-regulation skills of monitoring symptoms of distress and anxiety) and emotional neural processing (e.g. teaching participants to experience the moment non-judgmentally and directing thoughts to think positive thoughts and feel positive feelings like kindness and compassion. Receives: Behavioral: Stop, Breathe & Think™; Behavioral: End of Life Planning Videos |
| Meditation Only | Active comparator | This arm has the single content component of kindness based meditation delivered by using the Stop, Breathe \& Think™ application. This group will also be instructed to view 3 caregiver wellness videos. Receives: Behavioral: Stop, Breathe & Think™; Behavioral: Caregiver wellness videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Measured: At 10 months
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Measured: At 1 month
Secondary outcomes (6)
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
Measure of caregiver distress
Measured: From baseline to up to 10 months
Change in Degner's Decisional Control Scale
Measure of decisional control
Measured: From baseline to up to 10 months
Change in End of Life Value
Measure of end of life values and focus of care
Measured: From baseline to up to 10 months
Change in PROMIS-29 Scale
Measure of caregiver anxiety
Measured: From baseline to up to 10 months
Change in O'Connor's Decisional Regret Scale
Measure of decisional regret
Measured: From baseline to up to 10 months
Change in FAMCARE Scale
Measure of satisfaction with end of life care
Measured: From baseline to up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Gastrointestinal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Douglas, PhD, RN, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842047
- Sponsor's protocol ID
- CASE4815
- Status last verified
- Apr 2019
- First submitted
- 20 Jul 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
PubMed 32205788
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Stress in Caregivers of Cancer Patients
- ClinicalTrials.gov ID
- NCT02842047
- Acronym / sponsor ID
- CASE4815
- Keywords
- caregiver, end of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 22 Jul 2016 (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.
Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. The purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. One group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. Investigators will randomly assign participants to each group.
Detailed description
Investigators will conduct a randomized trial pilot study to examine two arms of the intervention among 20 caregivers of patients with advanced cancer. Investigators will collect mixed methods data to describe changes in proximal and distal outcomes. Investigators have chosen the time points to capture neural and behavioral changes associated with the intervention and to capture end of life quality of life (QOL) for a majority of caregivers after death of their loved one. Investigators aim to:
- Evaluate the short and longer-term effects of the end of life care with medication (EOL_M) and meditation only (M_Only) interventions on stress reduction and end of life (EOL) planning behaviors and determine if there are different effects between EOL_M and M_ Only interventions.
- Evaluate the short-term and long-term effects of the intervention on caregiver distress, decisional regret, and EOL values and goals of care for treatment.
- Evaluate the impact of decentering on the association between the interventions, self-management behaviors (stress reduction and EOL planning behaviors) and distress, anxiety, concordance between EOL values and goals of care for treatment, decisional regret and satisfaction with EOL care.
- Describe the neural activity processes that are associated with increased self-management activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End of Life Care with Meditation | Experimental | Behavioral: Stop, Breathe & Think™, Behavioral: End of Life Planning VideosThe intervention has two content components: end of life planning education (using end of life planning videos) and strategies and kindness based meditation (using the Stop, Breathe \& Think™ app). The activities comprising these components work together to improve both analytic neural processing (e.g. improving knowledge about goal setting and EOL planning, learning self-monitoring of EOL values and goals of care, and self-regulation skills of monitoring symptoms of distress and anxiety) and emotional neural processing (e.g. teaching participants to experience the moment non-judgmentally and directing thoughts to think positive thoughts and feel positive feelings like kindness and compassion. |
| Meditation Only | Active comparator | Behavioral: Stop, Breathe & Think™, Behavioral: Caregiver wellness videosThis arm has the single content component of kindness based meditation delivered by using the Stop, Breathe \& Think™ application. This group will also be instructed to view 3 caregiver wellness videos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- caregivers of patients who have been diagnosed with Stage IV gastrointestinal (GI) cancer
- coming with the patient at the Seidman Comprehensive Cancer Center at University Hospitals Case Medical Center (UHCMC)
- have access to the internet and a computer, tablet, or smart phone, and
- speak and comprehend English.
Key exclusion criteria (7 listed)
- currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
- require psychotherapy within the last three months
- have a history of dementia, major neurological illness
- pregnant
- history of a medical condition or procedure that is contraindicated for functional magnetic resonance imaging (fMRI) scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
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 |
|---|---|---|
| Stop, Breathe & Think™Also: meditation apponline daily meditations delivered using smart phone or other computer based application | Behavioural | End of Life Care with Meditation, Meditation Only |
| End of Life Planning VideosAlso: online videosThree videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though key aspects of end of life planning. | Behavioural | End of Life Care with Meditation |
| Caregiver wellness videosThree videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness. | Behavioural | Meditation Only |
Primary outcome
Repeated Measures ANCOVA Model (F-Statistic)
Time frame: At 10 months
Estimation of effect of the intervention
Repeated Measures ANCOVA Model (F-Statistic)
Time frame: At 1 month
Estimation of effect of the intervention
6 secondary outcomes
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
Time frame: From baseline to up to 10 months
Change in Degner's Decisional Control Scale
Time frame: From baseline to up to 10 months
Change in End of Life Value
Time frame: From baseline to up to 10 months
Change in PROMIS-29 Scale
Time frame: From baseline to up to 10 months
Change in O'Connor's Decisional Regret Scale
Time frame: From baseline to up to 10 months
Change in FAMCARE Scale
Time frame: From baseline to up to 10 months
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 4 Apr 2019.
- Derived from this study: PubMed 32205788Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
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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, PhD, RN 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 Stop, Breathe & Think™, End of Life Planning Videos and Caregiver wellness videos in people with Stage IV Gastrointestinal Cancer and Advanced Gynecological Cancer, 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 4 inclusion and 7 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 4 Apr 2019. 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?
Repeated Measures ANCOVA Model (F-Statistic) (time frame: At 10 months). The study lists 2 primary outcomes in all. 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 NCT02842047, which also lists 1 linked publication.
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 4 Apr 2019.