NCT01621295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

June 14, 2012

Last Update Submit

January 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

University of Southern California - Norris

Los Angeles, California, 90033, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsBreast NeoplasmsEndocrine Gland NeoplasmsGastrointestinal NeoplasmsUrogenital NeoplasmsHead and Neck NeoplasmsLung NeoplasmsMelanomaSarcoma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms, Connective and Soft Tissue

Study Officials

  • Jon C Tilburt, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations