- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074071
Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of the proposed research is to study the impact of hope interventions on the coping behavior of women with advanced breast cancer and physicians who provide care to patients with cancer.
It is the investigator's contention, that improved hopefulness among cancer patients can be manifest in improved Quality of Life (QOL). The challenge is to find specific interventions that can optimize hopefulness and thereby direct individuals to adopt behavior styles that contribute to a positive effect on QOL.
Two separate single-day interventions and hope applications will be developed for patients and oncologists, respectively. What will be common for each workshop is that there will be an experienced counselor designated as "coordinator" who will be in charge of implementing the program and monitoring group dynamics. The interventions will be structured with the program advancing from the identification of goals to the development of directions reasonable pathways for achieving the delineated goals. In addition to goal-directed exercises, the workshop will employ narrative techniques which utilize literary triggers as a springboard for reflective writing.
The smartphone-based application will prompt study participants on a daily basis to engage in additional, short activities designed to augment hopefulness, assess progress in achieving goals, and identifying challenges. In addition, the application will allow sustained interaction of workshop participants through social media exchange.
Course materials will be sent to study participants one week prior to the conduct of the workshop.
Baseline assessment of hopefulness will be carried out via the aforementioned validated scales on the day of the workshop.
Re-assessment of hopefulness will occur at the end of the day and at the 3- month interval visits.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion Criteria (patient component of study)
- Diagnosis of invasive breast cancer that is Stage IV.
- Female, 18 years of age or older.
- Able to proficiently speak, read, write English.
- ECOG performance status between 0 and 3.
- Subjects must have a smartphone with at least "3rd generation" mobile technology, and willingness to download and utilize specialized application
- Expected to continue cancer care at the institution where cancer was begun for the duration of the study.
Inclusion Criteria (physician component of study)
Board certification or board eligibility in any of the 3 oncologic disciplines:
- Medical Oncology
- Surgical Oncology
- Radiation Oncology
- Able to proficiently speak, read, write English.
- Subjects must have a smartphone with at least "3rd generation" mobile technology, and willingness to download and utilize specialized application
- NB: There will not be active recruitment of physicians who are subordinate to the respective investigators. In the event that such a physician desires to enroll on the study, formal application will be made to the institutional ethics committees to verify that coercion has not taken place.
Exclusion Criteria:
Exclusion Criteria (applies to both patients and physicians)
- Participant actively undergoing psychotherapy for depression.
- Documented history of Alzheimer's disease or other forms of dementia.
- Participants practicing mindfulness meditation for an average of more than 1 hour/week.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Breast Cancer patient
Patients with Stage IV breast cancer will be taught to build hope by defining attainable goals for themselves in a Hope Enhancement Workshop.
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Participants in the workshops will be prompted and guided through exercises that help them get in touch with goals that are not explicitly related to cure of disease.
These goals will include symptom relief and other personal and or professional objectives.
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Active Comparator: Oncologists
Oncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop.
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Participants in the workshops will be prompted and guided through exercises that help them get in touch with goals that are not explicitly related to cure of disease.
These goals will include symptom relief and other personal and or professional objectives.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the change in Hope Enhancement
Time Frame: The primary measurement will be carried out prior to and 3 months following the workshop
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Enhancement of hopefulness as measured by Adult Hope Scale
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The primary measurement will be carried out prior to and 3 months following the workshop
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Measurement of the change in Hopefulness
Time Frame: The primary measurement will be carried out prior to and 3 months following the workshop
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Enhancement of hopefulness as measured by Herth Hope Index.
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The primary measurement will be carried out prior to and 3 months following the workshop
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Measurement of the change in Quality of Life and Emotional Stress Anxiety
Time Frame: The primary measurement will be carried out prior to and 3 months following the workshop
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The study will measure QOL and emotional stress anxiety prior to and 3 months following the intervention.
Towards these ends, we will use the Patient-Reported Outcomes Measurement Information System (PROMIS) scale (10-point version).
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The primary measurement will be carried out prior to and 3 months following the workshop
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Measurement of the change in Quality of Life and Well Being
Time Frame: The primary measurement will be carried out prior to and 3 months following the workshop
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The study will measure QOL and well-being prior to and 3 months following the intervention.
Towards these ends, we will use the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) scale.
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The primary measurement will be carried out prior to and 3 months following the workshop
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the change in burnout among oncologists
Time Frame: The measurement will be carried out prior to and 3 months following the workshop.
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The study will measure burnout among oncologists using the Maslach Burnout Inventory Scale (MBI) to gauge the willingness of oncologists to incorporate hope enhancement techniques to their clinical routine with patients following the workshop intervention.
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The measurement will be carried out prior to and 3 months following the workshop.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TASMC-17-OG-0619-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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