Clinical trial NCT00674804: Communicating a Cancer Diagnosis-Current Methods and Their Effects
Official title: Communicating a Cancer Diagnosis: Current Methods and Their Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior
Cancer
Keywords: Communicating a Diagnosis
Cancer Diagnosis
Recurrence of Cancer
Initial Cancer Diagnosis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2008-05-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: This study will investigate how patients are informed of their cancer diagnosis or recurrence and will explore their experience in learning about the diagnosis. Specifically, it will:

* Distinguish methods of telling the diagnosis and identify its relationship to the type of cancer.
* Determine if the way a patient is informed of their diagnosis is associated with their level of satisfaction with the method of being informed.
* Identify who informs the patient of their diagnosis..
* Determine patient satisfaction with their diagnostic consult.
* Identify indicators of satisfaction with the diagnostic consultation.

Patients 18 years of age or older who are enrolled in or being screened for enrollment in a phase I, II or III clinical trial in the National Cancer Institute's Medical Oncology, Metabolism, Surgery or Neuro-Oncology branch may be eligible for this study.

Participants complete a 15-minute questionnaire that includes questions related to the how they were informed of their cancer diagnosis.

Detailed description: Background:

- The goals of the study are to identify how a patient with a diagnosis of cancer is informed of their condition and to illuminate the way in which this information exchange occurs.

Objectives:

To distinguish, identify and determine:

* If the method by which a patient is informed of a diagnosis of cancer is associated with their level of satisfaction with that method of being informed
* Who tells the patient of their condition
* The methods used to inform a patient of their condition
* Prognostic indicators of high satisfaction within the diagnostic consult

Eligibility:

* Patients currently enrolled or being screened for enrollment for a phase I, II or III clinical trial at the National Cancer Institutes clinic center- specifically, within the following branch clinics: Medical Oncology, Metabolism, Surgery and Neuro-Oncology.
* Patient must be 18 years or older and be willing to participate in the study.

Design:

* Primary methodological practice is a self-administered questionnaire.
* Questionnaire to be completed by patient on same day that it is administered at NCI.

Eligibility criteria: -INCLUSION CRITERIA:

1. Age greater than or equal to 18 years.
2. A patient diagnosed with cancer who is either currently enrolled in a protocol and receiving treatment or has come to NCI for consult and potential enrollment in a trial.
3. Ability to follow basic verbal instructions as observed by either an investigator of the study or as reported by a member of the patient's primary clinical team.
4. Patient must comprehend English, verbal and written, to be determined by the investigator distributing the questionnaire.

   -Patients with a hearing and/or visual impairment will be eligible to participate in the study if they so choose. Appropriate accommodations will be made.
5. Signed informed consent form.

EXCLUSION CRITERIA:

1. Patients that have cognitive impairments, such as mental challenges/retardation due to a congenital or developmental anomaly.

   a. Subjects with cognitive impairments are ineligible to participate in the study due to comprehension inabilities.
2. Patients who have developed dementia as a result of their disease or from an unspecified source are not eligible for participation due to both memory and overall cognitive deficits.
3. Patients that have multiple concurrent cancers are excluded from participation in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
citation: Maguire P, Pitceathly C. Key communication skills and how to acquire them. BMJ. 2002 Sep 28;325(7366):697-700. doi: 10.1136/bmj.325.7366.697. No abstract available.
citation: Zachariae R, Pedersen CG, Jensen AB, Ehrnrooth E, Rossen PB, von der Maase H. Association of perceived physician communication style with patient satisfaction, distress, cancer-related self-efficacy, and perceived control over the disease. Br J Cancer. 2003 Mar 10;88(5):658-65. doi: 10.1038/sj.bjc.6600798.
citation: Barnett MM. Does it hurt to know the worst?--psychological morbidity, information preferences and understanding of prognosis in patients with advanced cancer. Psychooncology. 2006 Jan;15(1):44-55. doi: 10.1002/pon.921.