Breast NeoplasmsNCT02707510
A Trial to Strengthen Existential Resiliency Among Women With Metastatic Breast Cancer
A study testing Growing Resiliency And CouragE with Cancer™ (GRACE) in people with Breast Neoplasms and Neoplasm Metastasis, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- Growing Resiliency And CouragE with Cancer™ (GRACE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Mar 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with metastatic cancer with a minimum prognosis of 3 months
- Existential or spiritual concerns
- Reasonable medical stability as assessed by the evaluating physician
- Commits to attending 5/6 of the GRACE classes
- English speaking
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Unstable psychiatric disorder that would detract from a group program (i.e. severe depression/anxiety not controlled medically, volatile personality disorders)
- Cognitive impairment or cognitive linguistic impairment (i.e., aphasia) that would interfere with a group program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer
The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving psycho-education and process-oriented experiences. The curriculum includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- Growing Resiliency And CouragE with Cancer™ (GRACE)
- Keywords
- logotherapy, cognitive behavior therapy, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growing Resiliency And CouragE with Cancer™ (GRACE)Other
GRACE is a 6 week curriculum which includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients in the intervention group will be provided with all programmatic materials (including copies of power point presentations, copies of reading texts, and audio CDs) and classes will be held in group format, with a maximum of 9 participants per group. Classes will meet weekly, in a group, and at a set time. All classes will be facilitated jointly by the two Co-PIs. All participants will complete surveys before class, during class, at the end of class, 1 month after the end of class, 6 months after the end of class and 1 year after the end of the class. Additionally, those randomized to the intervention group will be asked to attend a 1 time focus group 1 week after the end of the class. Receives: Other: Growing Resiliency And CouragE with Cancer™ (GRACE) |
| Control Arm | No intervention | Patients in the control group will be asked to complete surveys at: baseline, 6 weeks after baseline (T1), and 1 month after T1. After T1, the control group will off study and will be permitted to attend the next available GRACE course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRACE's Impact on Existential Distress (measured by survey)
Measured: Baseline to 6 weeks after baseline
Secondary outcomes (9)
GRACE's Impact on Existential Distress (measured by survey)
Measured: Baseline to 10 weeks after baseline
GRACE's Impact on anxiety (measured by survey)
Measured: Baseline to 6 weeks after baseline
GRACE's Impact on anxiety (measured by survey)
Measured: Baseline to 10 weeks after baseline
GRACE's Impact on depression (measured by survey)
Measured: Baseline to 6 weeks after baseline
GRACE's Impact on depression (measured by survey)
Measured: Baseline to 10 weeks after baseline
GRACE's Impact on hopelessness (measured by survey)
Measured: Baseline to 6 weeks after baseline
GRACE's Impact on hopelessness (measured by survey)
Measured: Baseline to 10 weeks after baseline
GRACE's Impact on loneliness (measured by survey)
Measured: Baseline to 6 weeks after baseline
GRACE's Impact on loneliness (measured by survey)
Measured: Baseline to 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2019
- Study completionMar 2020
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 Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arash Asher, MD, Cedars-Sinai Medical Center
- Investigators
- Arash Asher, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707510
- Sponsor's protocol ID
- Pro00043233
- Status last verified
- May 2020
- First submitted
- 9 Mar 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Asher A, Shirazipour CH, Capaldi JM, Kim S, Diniz M, Jones B, Wertheimer J. A 6-Week Program to Strengthen Resiliency Among Women With Metastatic Cancer: A Randomized Clinical Trial. Oncologist. 2023 Aug 3;28(8):e669-e682. doi: 10.1093/oncolo/oyad091.
PubMed 37104871
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02707510
- Acronym / sponsor ID
- Pro00043233
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- logotherapy, cognitive behavior therapy, metastatic breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 14 Mar 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.
The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving psycho-education and process-oriented experiences. The curriculum includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Growing Resiliency And CouragE with Cancer™ (GRACE)Patients in the intervention group will be provided with all programmatic materials (including copies of power point presentations, copies of reading texts, and audio CDs) and classes will be held in group format, with a maximum of 9 participants per group. Classes will meet weekly, in a group, and at a set time. All classes will be facilitated jointly by the two Co-PIs. All participants will complete surveys before class, during class, at the end of class, 1 month after the end of class, 6 months after the end of class and 1 year after the end of the class. Additionally, those randomized to the intervention group will be asked to attend a 1 time focus group 1 week after the end of the class. |
| Control Arm | No intervention | –Patients in the control group will be asked to complete surveys at: baseline, 6 weeks after baseline (T1), and 1 month after T1. After T1, the control group will off study and will be permitted to attend the next available GRACE course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with metastatic cancer with a minimum prognosis of 3 months
- Existential or spiritual concerns
- Reasonable medical stability as assessed by the evaluating physician
- Commits to attending 5/6 of the GRACE classes
- English speaking
Key exclusion criteria (2 listed)
- Unstable psychiatric disorder that would detract from a group program (i.e. severe depression/anxiety not controlled medically, volatile personality disorders)
- Cognitive impairment or cognitive linguistic impairment (i.e., aphasia) that would interfere with a group program.
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 |
|---|---|---|
| Growing Resiliency And CouragE with Cancer™ (GRACE)GRACE is a 6 week curriculum which includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum. | Other | Intervention Arm |
Primary outcome
GRACE's Impact on Existential Distress (measured by survey)
Time frame: Baseline to 6 weeks after baseline
9 secondary outcomes
GRACE's Impact on Existential Distress (measured by survey)
Time frame: Baseline to 10 weeks after baseline
GRACE's Impact on anxiety (measured by survey)
Time frame: Baseline to 6 weeks after baseline
GRACE's Impact on anxiety (measured by survey)
Time frame: Baseline to 10 weeks after baseline
GRACE's Impact on depression (measured by survey)
Time frame: Baseline to 6 weeks after baseline
GRACE's Impact on depression (measured by survey)
Time frame: Baseline to 10 weeks after baseline
GRACE's Impact on hopelessness (measured by survey)
Time frame: Baseline to 6 weeks after baseline
GRACE's Impact on hopelessness (measured by survey)
Time frame: Baseline to 10 weeks after baseline
GRACE's Impact on loneliness (measured by survey)
Time frame: Baseline to 6 weeks after baseline
GRACE's Impact on loneliness (measured by survey)
Time frame: Baseline to 10 weeks after baseline
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 May 2020.
- Derived from this study: PubMed 37104871Asher A, Shirazipour CH, Capaldi JM, Kim S, Diniz M, Jones B, Wertheimer J. A 6-Week Program to Strengthen Resiliency Among Women With Metastatic Cancer: A Randomized Clinical Trial. Oncologist. 2023 Aug 3;28(8):e669-e682. doi: 10.1093/oncolo/oyad091.
- Individual participant dataSharing planned: No
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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.
Arash Asher, MD principal investigator
Cedars-Sinai Medical 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 Growing Resiliency And CouragE with Cancer™ (GRACE) in people with Breast Neoplasms and Neoplasm Metastasis, run by Cedars-Sinai Medical 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 6 inclusion and 2 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 May 2020. 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?
GRACE's Impact on Existential Distress (measured by survey) (time frame: Baseline to 6 weeks after baseline). 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 NCT02707510, 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 May 2020.