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Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Despair Among Cancer Patients and Oncologists

Treatments

Behavioral: Hope Enhancement Workshop

Study type

Interventional

Funder types

Other

Identifiers

NCT03074071
TASMC-17-OG-0619-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Breast Cancer patient
Active Comparator group
Description:
Patients with Stage IV breast cancer will be taught to build hope by defining attainable goals for themselves in a Hope Enhancement Workshop.
Treatment:
Behavioral: Hope Enhancement Workshop
Oncologists
Active Comparator group
Description:
Oncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop.
Treatment:
Behavioral: Hope Enhancement Workshop

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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