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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01621295
Other study ID # 11-006682
Secondary ID R01AT006515
Status Completed
Phase N/A
First received June 14, 2012
Last updated January 18, 2016
Start date May 2012
Est. completion date September 2015

Study information

Verified date January 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 408
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

N/A


Locations

Country Name City State
United States Los Angeles County Hospital Los Angeles California
United States University of Southern California - Norris Los Angeles California
United States Mayo Clinic Rochester Minnesota

Sponsors (4)

Lead Sponsor Collaborator
Mayo Clinic Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH), University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time of enrollment through completion of 3 month follow-up survey No
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