Assessing the Patient Experience in Cancer Care
Primary Purpose
Brain Neoplasm, Breast Neoplasm, Endocrine Gland Neoplasm
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Brain Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 18 years
- Histological confirmation of: brain, breast, endocrine, gastrointestinal, genitourinary, gynecological, head/neck, lung, melanoma, or sarcoma malignancies.
- Speak English or Spanish
- Not enrolled in hospice
- In any of the following phases of the cancer control continuum: initial diagnosis, initial treatment, early survivorship, or recurrence.
- Provide written informed consent
Exclusion Criteria:
Sites / Locations
- Los Angeles County Hospital
- University of Southern California - Norris
- Mayo Clinic
Outcomes
Primary Outcome Measures
Frequency/duration/content of routine cancer consultations surrounding key topics in the clinical dialogue.
Key topics to be studied include: quality of life, complementary and alternative therapies, psycho-social characteristics, patient-clinician dynamics, health literacy
Secondary Outcome Measures
Full Information
NCT ID
NCT01621295
First Posted
June 14, 2012
Last Updated
January 18, 2016
Sponsor
Mayo Clinic
Collaborators
University of Southern California, Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01621295
Brief Title
Assessing the Patient Experience in Cancer Care
Official Title
Assessing the Patient Experience in Cancer Care: An Observational Communication Study
Study Type
Observational
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Southern California, Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Communication is an important component of comprehensive cancer care impacting patient satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer clinical interactions makes communicating about a broad range of topics (including quality of life, communication, symptom control, complementary/alternative therapies, costs, treatment burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.) especially interesting and potentially challenging. Some of these topics may not be routinely addressed in the clinical interaction or may require consultative support from other members of the comprehensive cancer care team. One frequently overlooked critical element in research on communication between cancer clinicians, their patients, and their primary care clinicians is describing real-time consultations between patients and their clinicians. These interactions provide rich material for assessing key psycho-social dynamics and identifying issues that patients find important in their care. In order to devise systems of care that optimize the patient experience, it is critical that clinicians and researchers understand, appreciate, and systematically characterize the richness and complexity of the decision-making process in routine cancer consultations between cancer patients and their treating clinicians. This study seeks to assess the patient experience in cancer care by observing patients and their physicians in their clinical interactions and following them for several months to see how their care went. By describing in-depth the conversations and experiences of patients in these clinical interactions, this study will lay the foundation for practice-based interventions to optimize patients' interactions with their cancer care teams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm, Breast Neoplasm, Endocrine Gland Neoplasm, Gastrointestinal Neoplasm, Genitourinary Neoplasm, Gynecological Neoplasm, Head and Neck Neoplasm, Lung Neoplasm, Melanoma, Sarcoma
7. Study Design
Enrollment
408 (Actual)
Primary Outcome Measure Information:
Title
Frequency/duration/content of routine cancer consultations surrounding key topics in the clinical dialogue.
Description
Key topics to be studied include: quality of life, complementary and alternative therapies, psycho-social characteristics, patient-clinician dynamics, health literacy
Time Frame
Time of enrollment through completion of 3 month follow-up survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than or equal to 18 years
Histological confirmation of: brain, breast, endocrine, gastrointestinal, genitourinary, gynecological, head/neck, lung, melanoma, or sarcoma malignancies.
Speak English or Spanish
Not enrolled in hospice
In any of the following phases of the cancer control continuum: initial diagnosis, initial treatment, early survivorship, or recurrence.
Provide written informed consent
Exclusion Criteria:
Study Population Description
Cancer patients age 18 or over receiving care from clinicians who have also consented to participate in this study at Mayo Clinic Rochester, University of Southern California-Norris, or LA County Hospital.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon C Tilburt, MD, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Southern California - Norris
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessing the Patient Experience in Cancer Care
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