Brain NeoplasmNCT01621295
Assessing the Patient Experience in Cancer Care
An observational study of Brain Neoplasm and Breast Neoplasm, run by Mayo Clinic at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasm, Breast Neoplasm, Endocrine Gland Neoplasm
- How many people
- 408 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles County Hospital
Los Angeles, California, 90033
University of Southern California - Norris
Los Angeles, California, 90033
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Assessing the Patient Experience in Cancer Care: An Observational Communication Study
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.
- Conditions
- Brain Neoplasm, Breast Neoplasm, Endocrine Gland Neoplasm, Gastrointestinal Neoplasm, Genitourinary Neoplasm, Gynecological Neoplasm
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Endocrine Gland Neoplasms, Gastrointestinal Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time of enrollment through completion of 3 month follow-up survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jon C. Tilburt, Mayo Clinic
- Investigators
- Jon C Tilburt, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621295
- Sponsor's protocol ID
- 11-006682
- Other IDs
- R01AT006515
- Status last verified
- Jan 2016
- First submitted
- 14 Jun 2012
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Patient Experience in Cancer Care: An Observational Communication Study
- ClinicalTrials.gov ID
- NCT01621295
- Acronym / sponsor ID
- 11-006682
- Conditions
- Brain Neoplasm, Breast Neoplasm, Endocrine Gland Neoplasm, Gastrointestinal Neoplasm, Genitourinary Neoplasm, Gynecological Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Southern California, Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency/duration/content of routine cancer consultations surrounding key topics in the clinical dialogue.
Time frame: Time of enrollment through completion of 3 month follow-up survey
Key topics to be studied include: quality of life, complementary and alternative therapies, psycho-social characteristics, patient-clinician dynamics, health literacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon C Tilburt, MD, MPH principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasm and Breast Neoplasm, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency/duration/content of routine cancer consultations surrounding key topics in the clinical dialogue. (time frame: Time of enrollment through completion of 3 month follow-up survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.