Despair Among Cancer Patients and OncologistsNCT03074071
Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
A study testing Hope Enhancement Workshop in people with Despair Among Cancer Patients and Oncologists, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
Trial summary
The study will access whether breast cancer patients and oncologists can become more hopeful after participating in a "hope enhancement workshop." Several validated tools, Adult Hope Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI)" and other quality of life parameter surveys, will be administered… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Despair Among Cancer Patients and Oncologists
- What is being tested?
- Hope Enhancement Workshop
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Nov 2017to Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
The study will access whether breast cancer patients and oncologists can become more hopeful after participating in a "hope enhancement workshop." Several validated tools, Adult Hope Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI)" and other quality of life parameter surveys, will be administered at specified intervals.
Read the 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.
- Being tested
- Hope Enhancement Workshop
- Keywords
- Disambiguation, Depression, Burnout
- Medical subject headings
- Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope Enhancement WorkshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patient | Active comparator | Patients with Stage IV breast cancer will be taught to build hope by defining attainable goals for themselves in a Hope Enhancement Workshop. Receives: Behavioral: Hope Enhancement Workshop |
| Oncologists | Active comparator | Oncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop. Receives: Behavioral: Hope Enhancement Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the change in Hope Enhancement
Enhancement of hopefulness as measured by Adult Hope Scale
Measured: The primary measurement will be carried out prior to and 3 months following the workshop
Measurement of the change in Hopefulness
Enhancement of hopefulness as measured by Herth Hope Index.
Measured: The primary measurement will be carried out prior to and 3 months following the workshop
Measurement of the change in Quality of Life and Emotional Stress Anxiety
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).
Measured: The primary measurement will be carried out prior to and 3 months following the workshop
Measurement of the change in Quality of Life and Well Being
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.
Measured: The primary measurement will be carried out prior to and 3 months following the workshop
Secondary outcomes (1)
Measurement of the change in burnout among oncologists
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.
Measured: The measurement will be carried out prior to and 3 months following the workshop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start8 Nov 2017
- Primary completionNov 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Despair Among Cancer Patients and OncologistsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be offered participation in workshops where techniques are taught for enhancing hopefulness. Validated questionnaires will be administered before and after this intervention to assess efficacy.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074071
- Sponsor's protocol ID
- TASMC-17-OG-0619-CTIL
- Status last verified
- Nov 2017
- First submitted
- 23 Feb 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
- ClinicalTrials.gov ID
- NCT03074071
- Acronym / sponsor ID
- TASMC-17-OG-0619-CTIL
- Keywords
- Disambiguation, Depression, Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Duke University
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Mar 2017 (actual)
- 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 will access whether breast cancer patients and oncologists can become more hopeful after participating in a "hope enhancement workshop." Several validated tools, Adult Hope Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI)" and other quality of life parameter surveys, will be administered at specified intervals.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be offered participation in workshops where techniques are taught for enhancing hopefulness. Validated questionnaires will be administered before and after this intervention to assess efficacy.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patient | Active comparator | Behavioral: Hope Enhancement WorkshopPatients with Stage IV breast cancer will be taught to build hope by defining attainable goals for themselves in a Hope Enhancement Workshop. |
| Oncologists | Active comparator | Behavioral: Hope Enhancement WorkshopOncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Hope Enhancement WorkshopParticipants 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. | Behavioural | Breast Cancer patient, Oncologists |
Primary outcome
Measurement of the change in Hope Enhancement
Time frame: The primary measurement will be carried out prior to and 3 months following the workshop
Enhancement of hopefulness as measured by Adult Hope Scale
Measurement of the change in Hopefulness
Time frame: The primary measurement will be carried out prior to and 3 months following the workshop
Enhancement of hopefulness as measured by Herth Hope Index.
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
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).
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
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.
1 secondary outcome
Measurement of the change in burnout among oncologists
Time frame: The measurement will be carried out prior to and 3 months following the workshop.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Enhancement Workshop in people with Despair Among Cancer Patients and Oncologists, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
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 13 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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?
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?
Measurement of the change in Hope Enhancement (time frame: The primary measurement will be carried out prior to and 3 months following the workshop). The study lists 4 primary outcomes in all. 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 27 Nov 2017.