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

NCT ID: NCT03074071

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Despair Among Cancer Patients and Oncologists

Keywords

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Disambiguation, Depression, Burnout

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hope Enhancement Workshop

Intervention Type BEHAVIORAL

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.

Oncologists

Oncologists will will be taught to build hope by defining attainable goals for themselves and for their patients in a Hope Enhancement Workshop.

Group Type ACTIVE_COMPARATOR

Hope Enhancement Workshop

Intervention Type BEHAVIORAL

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.

Interventions

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Hope Enhancement Workshop

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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TASMC-17-OG-0619-CTIL

Identifier Type: -

Identifier Source: org_study_id