Clinical trial NCT01673581: Shared Decision Making in Low Risk Prostate Cancer
Official title: Shared Decision Making: A Study Assessing the Benefit of a Web Based Aid Presenting Treatment Options for Patients With Low Risk Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Low Risk
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 141
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low risk prostate cancer patients seen wthin the Claire \& John Bertucci Center for Genitourinary Cancers multidisciplinary clinic at MGH.

Brief summary: This study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. The investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments they choose.

Detailed description: Investigators will first ask patients to answer a series of questions to assess their wishes regarding treatment, knowledge about their disease and discussion with the physicians at initial patient visit. This initial survey should take approximately 20 minutes. Once patients have selected a treatment path investigators will contact them again and ask them to fill out a short 10-minute survey online or by mail. Investigators will contact patients by phone 2 weeks after their initial visit to see if they have made a decision. If not, investigators will contact patients by phone every 2 weeks or at an interval that works for the patient's schedule. Finally, 3 months after the initial visit today investigators will contact patients for the last time and again ask you to fill out a short 10-minute survey online or by mail.

Once patients have completed the final survey there are no future surveys planned. Investigators may contact patients by phone in the future to ask them to participate in another study.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* Internet access
* Able to read and understand English

Exclusion Criteria:

* Evidence of nodal metastases
* Evidence of distant metastases
* Prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for prostate cancer

Primary outcomes:
measure: Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.
timeFrame: 2 years
Secondary outcomes:
measure: Decisional conflict and informed decision making experienced by patients.
timeFrame: 2 years
measure: Patient health related worry.
timeFrame: 2 years
measure: Patient views on cancer control for their treatment choice.
timeFrame: 2 years
measure: Patient satisfaction with their treatment choice.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jason A. Efstathiou, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: