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

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03074071
Collaborator
Duke University (Other)
120
2
2
36.8
60
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hope Enhancement Workshop
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Supportive Care
Official Title:
Enhancing Hope Among Patients With Poor-Prognosis Breast Cancer and Oncologists
Actual Study Start Date :
Nov 8, 2017
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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.

Behavioral: 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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Measurement of the change in Hope Enhancement [The primary measurement will be carried out prior to and 3 months following the workshop]

    Enhancement of hopefulness as measured by Adult Hope Scale

  2. Measurement of the change in Hopefulness [The primary measurement will be carried out prior to and 3 months following the workshop]

    Enhancement of hopefulness as measured by Herth Hope Index.

  3. Measurement of the change in Quality of Life and Emotional Stress Anxiety [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).

  4. Measurement of the change in Quality of Life and Well Being [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.

Secondary Outcome Measures

  1. Measurement of the change in burnout among oncologists [The measurement will be carried out prior to and 3 months following the workshop.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
2 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239

Sponsors and Collaborators

  • Tel-Aviv Sourasky Medical Center
  • Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT03074071
Other Study ID Numbers:
  • TASMC-17-OG-0619-CTIL
First Posted:
Mar 8, 2017
Last Update Posted:
Nov 27, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tel-Aviv Sourasky Medical Center

Study Results

No Results Posted as of Nov 27, 2017