Clinical trial NCT03074071: Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
Official title: Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Despair Among Cancer Patients and Oncologists
Keywords: Disambiguation, Depression, Burnout
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Duke University
First posted: 2017-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of the change in Hope Enhancement
timeFrame: The primary measurement will be carried out prior to and 3 months following the workshop
measure: Measurement of the change in Hopefulness
timeFrame: The primary measurement will be carried out prior to and 3 months following the workshop
measure: Measurement of the change in Quality of Life and Emotional Stress Anxiety
timeFrame: The primary measurement will be carried out prior to and 3 months following the workshop
measure: Measurement of the change in Quality of Life and Well Being
timeFrame: The primary measurement will be carried out prior to and 3 months following the workshop
Secondary outcomes:
measure: Measurement of the change in burnout among oncologists
timeFrame: The measurement will be carried out prior to and 3 months following the workshop.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References: