CancerMODEL CareNCT02367508
Mindfully Optimizing Delivery of End-of-Life Care
A study testing MODEL Care in people with Cancer and Coping Skills, run by Indiana University.
Trial summary
The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Coping Skills
- What is being tested?
- MODEL Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2015
- 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
- Oncologists:
- Be a physician specializing in medical oncology
- Care for oncology patients at the affiliated cancer center
- Have a patient panel that will allow for ≥6 eligible patients to be enrolled in the study
- Be willing to attend the 5-session MODEL Care program for providers at the specified location, date, and time
- Patients:
Show all 19Show fewer
- Adults ≥ 18 years of age
- Receiving care from a medical oncologist enrolled in the study
- Diagnosed with an incurable and advanced-stage solid malignancy (late stage III [B or C] or stage IV)
- Have an attending medical oncologist who would not be surprised if the patient died in the next 12 months
- Willing and able to travel to the class location for 6 weekly 2-hour sessions
- Have a family member or friend eligible and interested in participating in the MODEL Care study
- Able and willing to provide informed consent
- Not have completed a Physician Orders for Scope of Treatment (POST) form
- Family Caregivers:
- Adults ≥18 years of age
- Chosen by a family member or friend with cancer to join them in participating in the MODEL Care study
- Willing and able to travel to the class location for 6 weekly 2-hour sessions
- Able and willing to consent.
Who cannot join
- Oncologists:
- Planning to leave current practice setting for other employment in the next 3 months.
- Patients:
- Eastern Cooperative Oncology Group (ECOG) performance status of >2 or Karnofsky performance status <60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist
- Currently receiving hospice care.
About this study
Official title: Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers
The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.
- Conditions
- Cancer, Coping Skills
- Being tested
- MODEL Care
- Keywords
- advance care planning, coping skills, mindfulness, meditation, cancer, adult, caregivers, oncology providers, advance directives, anxiety, depression, quality of life, pilot project
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODEL CareBehavioural
The Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) intervention is two-pronged and mutually interactive with: (1) a patient and family caregiver group, and (2) an oncology provider group. Patients and family caregivers meet as a group for 6 weekly sessions of 2 hours each, for a total of 12 hours of class time. Oncology providers will have 5 class sessions for a total of 16 hours of class time. One class is held conjointly with patients, family caregivers, and providers to practice newly-learned skills. The course curriculum is generally based on mindfulness practices, group discussion, and didactic teaching with an emphasis on embodying interpersonal mindfulness in dialogue in daily life.
| Study group | Role | What they receive |
|---|---|---|
| MODEL Care | Experimental | Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) is a mindfulness meditation-based intervention to facilitate timely advance care planning (ACP) and end-of-life conversations with greater ease. Participants are taught a variety of mindfulness practices (e.g., breath awareness, sitting meditation, mindful movement through gentle yoga, and mindful communication) that can be used to enhance end-of-life coping. Receives: Behavioral: MODEL Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rates at Baseline
The number of individuals who are eligible will be divided by the number of individuals approached.
Measured: Recruitment rates will be estimated at baseline.
Feasibility: Enrollment Rates at Baseline
The number of enrolled individuals will be divided by the number of eligible individuals.
Measured: Enrollment rates will be caluclated at baseline.
Feasibility: Attendance at Post-Intervention (6 weeks)
The mean number of sessions attended by each participant type (i.e., patients, family caregivers, providers) will be calculated and compared to the total number of MODEL care sessions provided (i.e., 6 for patients/family caregivers and 5 for providers).
Measured: Attendance will be calculated at the end of the intervention (6 weeks).
Feasibility: Retention Rates at Post-Intervention (6 weeks)
The proportion of the total number of participants enrolled who completed post-intervention assessments (at 6 weeks) will be calculated by dividing the number of individuals assessed post-intervention (6 weeks) by the number of participants who were enrolled/assessed at baseline.
Measured: Retention rates will be calculated at the end of the intervention (6 weeks).
Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
An investigator-created measure of intervention satisfaction will be administered. This measure includes items assessing participants' overall satisfaction, satisfaction with different components of the intervention, likelihood of recommending the course to others, and the intention to continue using MODEL Care skills. The mean score on the satisfaction scale will be calculated for each group (patients, family caregivers, and providers) post-intervention (6 weeks).
Measured: Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
The proportion of the total number of participants enrolled who completed 1-month follow-up assessments (at 10 weeks) will be calculated by dividing the number of individuals who were assessed at 1-month follow-up (10 weeks) by the number of participants enrolled/assessed at baseline.
Measured: Retention rates will be calculated at 1-month follow-up (10 weeks).
Secondary outcomes (10)
Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training, and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to post-intervention (6 weeks) for each group of participants on their respective measures.
Measured: Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to 1-month follow-up for each group of participants on their respective measures.
Measured: Avoidant coping will be measured at baseline and at 1-month follow up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to post-intervention (6 weeks) for each group of participants.
Measured: Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with the Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to 1-month follow up for each group of participants.
Measured: Quality of life will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at Post-Intervention (6 weeks)
Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to post-intervention ( 6 weeks) for each group of participants.
Measured: Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to 1-month follow up for each group of participants.
Measured: Depression will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at Post-Intervention (6 weeks)
Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to post-intervention (6 weeks) for each group of participants.
Measured: Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to 1-month follow up for each group of participants.
Measured: Anxiety will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to post-intervention (6 weeks) for patients.
Measured: Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to 1-month follow-up for patients.
Measured: Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionMay 2015
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 CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Walther Cancer Institute, Charles Warren Fairbanks Center for Medical Ethics
- Responsible party
- Sponsor
- Investigators
- Shelley A. Johns, PsyD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367508
- Sponsor's protocol ID
- 1312088151
- Acronym
- MODEL Care
- Status last verified
- Jul 2016
- First submitted
- 31 Dec 2014
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johns SA, Beck-Coon K, Stutz PV, Talib TL, Chinh K, Cottingham AH, Schmidt K, Shields C, Stout ME, Stump TE, Monahan PO, Torke AM, Helft PR. Mindfulness Training Supports Quality of Life and Advance Care Planning in Adults With Metastatic Cancer and Their Caregivers: Results of a Pilot Study. Am J Hosp Palliat Care. 2020 Feb;37(2):88-99. doi: 10.1177/1049909119862254. Epub 2019 Aug 4.
PubMed 31378080
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers
- ClinicalTrials.gov ID
- NCT02367508
- Acronym / sponsor ID
- MODEL Care / 1312088151
- Conditions
- Cancer, Coping Skills
- Keywords
- advance care planning, coping skills, mindfulness, meditation, cancer, adult, caregivers, oncology providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Walther Cancer Institute, Charles Warren Fairbanks Center for Medical Ethics
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Feb 2015 (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 study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MODEL Care | Experimental | Behavioral: MODEL CareMindfully Optimizing Delivery of End-of-Life Care (MODEL Care) is a mindfulness meditation-based intervention to facilitate timely advance care planning (ACP) and end-of-life conversations with greater ease. Participants are taught a variety of mindfulness practices (e.g., breath awareness, sitting meditation, mindful movement through gentle yoga, and mindful communication) that can be used to enhance end-of-life coping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Be a physician specializing in medical oncology
- Care for oncology patients at the affiliated cancer center
- Have a patient panel that will allow for ≥6 eligible patients to be enrolled in the study
- Be willing to attend the 5-session MODEL Care program for providers at the specified location, date, and time
- Adults ≥ 18 years of age
Key exclusion criteria (5 listed)
- Planning to leave current practice setting for other employment in the next 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of >2 or Karnofsky performance status <60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist
- Currently receiving hospice care.
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 |
|---|---|---|
| MODEL CareThe Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) intervention is two-pronged and mutually interactive with: (1) a patient and family caregiver group, and (2) an oncology provider group. Patients and family caregivers meet as a group for 6 weekly sessions of 2 hours each, for a total of 12 hours of class time. Oncology providers will have 5 class sessions for a total of 16 hours of class time. One class is held conjointly with patients, family caregivers, and providers to practice newly-learned skills. The course curriculum is generally based on mindfulness practices, group discussion, and didactic teaching with an emphasis on embodying interpersonal mindfulness in dialogue in daily life. | Behavioural | MODEL Care |
Primary outcome
Feasibility: Recruitment Rates at Baseline
Time frame: Recruitment rates will be estimated at baseline.
The number of individuals who are eligible will be divided by the number of individuals approached.
Feasibility: Enrollment Rates at Baseline
Time frame: Enrollment rates will be caluclated at baseline.
The number of enrolled individuals will be divided by the number of eligible individuals.
Feasibility: Attendance at Post-Intervention (6 weeks)
Time frame: Attendance will be calculated at the end of the intervention (6 weeks).
The mean number of sessions attended by each participant type (i.e., patients, family caregivers, providers) will be calculated and compared to the total number of MODEL care sessions provided (i.e., 6 for patients/family caregivers and 5 for providers).
Feasibility: Retention Rates at Post-Intervention (6 weeks)
Time frame: Retention rates will be calculated at the end of the intervention (6 weeks).
The proportion of the total number of participants enrolled who completed post-intervention assessments (at 6 weeks) will be calculated by dividing the number of individuals assessed post-intervention (6 weeks) by the number of participants who were enrolled/assessed at baseline.
Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
Time frame: Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
An investigator-created measure of intervention satisfaction will be administered. This measure includes items assessing participants' overall satisfaction, satisfaction with different components of the intervention, likelihood of recommending the course to others, and the intention to continue using MODEL Care skills. The mean score on the satisfaction scale will be calculated for each group (patients, family caregivers, and providers) post-intervention (6 weeks).
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
Time frame: Retention rates will be calculated at 1-month follow-up (10 weeks).
The proportion of the total number of participants enrolled who completed 1-month follow-up assessments (at 10 weeks) will be calculated by dividing the number of individuals who were assessed at 1-month follow-up (10 weeks) by the number of participants enrolled/assessed at baseline.
10 secondary outcomes
Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
Time frame: Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
Time frame: Avoidant coping will be measured at baseline and at 1-month follow up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
Time frame: Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
Time frame: Quality of life will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at Post-Intervention (6 weeks)
Time frame: Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
Time frame: Depression will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at Post-Intervention (6 weeks)
Time frame: Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
Time frame: Anxiety will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
Time frame: Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
Time frame: Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.
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 28 Jul 2016.
- Derived from this study: PubMed 31378080Johns SA, Beck-Coon K, Stutz PV, Talib TL, Chinh K, Cottingham AH, Schmidt K, Shields C, Stout ME, Stump TE, Monahan PO, Torke AM, Helft PR. Mindfulness Training Supports Quality of Life and Advance Care Planning in Adults With Metastatic Cancer and Their Caregivers: Results of a Pilot Study. Am J Hosp Palliat Care. 2020 Feb;37(2):88-99. doi: 10.1177/1049909119862254. Epub 2019 Aug 4.
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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.
Shelley A. Johns, PsyD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing MODEL Care in people with Cancer and Coping Skills, run by Indiana University.
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 19 inclusion and 5 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Feasibility: Recruitment Rates at Baseline (time frame: Recruitment rates will be estimated at baseline.). The study lists 6 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 NCT02367508, 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 28 Jul 2016.