Trial Information

Telephone-Based Decision Support for Rural Patients

Breast cancer patients are often advised to write down a list of questions before talking to
their surgeons or oncologists about treatment decisions. However, without support, newly
diagnosed patients may be too overwhelmed to make a list of their questions. Over the last
30 years, studies have shown that patients benefit from having a researcher or nurse prompt
them for questions or any concerns they may have before an upcoming appointment with their
primary healthcare provider. In some of these studies, the researcher or nurse then wrote
down the patient's questions so that the clinician could be sure to address them.

Today, few facilities provide this type of patient support, known as visit preparation,
perhaps because of the cost and/or organizational challenges. Our research team, a
partnership between the UCSF Decision Services and the Cancer Resource Centers of Mendocino
County (CRCMC) implemented a form of visit preparation known as Consultation Planning (CP).
The investigators have made CP work in our communities by training resource center staff to
deliver the service in face-to-face interviews with patients.

In a recent completed Pilot Study, the investigators collected and analyzed initial data
suggesting that CP is appropriate for diverse, rural patients in Mendocino County (including
Native Americans and Latinas), and that CP may be effective when delivered by telephone.

The investigators have now been awarded a grant to examine the effectiveness and
cost-effectiveness of delivering CP by telephone (Tele-CP) versus in person.

Primary Objectives:

- To measure and compare the impact of in-person CP and Tele-CP on decisional
self-efficacy (primary outcome), decisional conflict, anxiety, breast cancer-related
quality of life, and adherence to visits and treatments.

- To measure and compare the cost-effectiveness of in-person CP and Tele-CP

Secondary Objective:

• To measure physician satisfaction and perception of the decision process.

Study Hypotheses:

1. Tele-CP can be delivered at a lower patient and resource center intervention cost than
in-person CP.

2. Tele-CP patients will reach the same levels of decisional self-efficacy (primary
outcome), decisional conflict, anxiety, quality of life, and adherence to visits and
treatment as in-person CP patients.

3. Physicians will report equal satisfaction and will rate their decision process equally
whether the patient experienced CP or Tele-CP.

In 1996, Dr. Belkora and his colleagues evaluated CP at Stanford and UCSF, finding that it
reduced perceived barriers to communication and improved satisfaction for patients and
physicians. CP has been available at the UCSF Cancer Resource Center since 1999, where it is
advertised to all cancer patients through brochures and flyers. CP has also been integrated
into the clinical processes at the UCSF Breast Care Center since 1998, where it is now
offered to every patient with new or locally recurrent disease who is facing early-stage
breast cancer treatment decisions.

In 2003, Dr. Belkora was awarded research funding from the California Breast Cancer Research
Program to implement a Pilot Study entitled: Decision Support in Rural Underserved North
Coast Counties. This pilot project documented, in a retrospective design, that both onsite
and Tele-CP were associated with high satisfaction or decision self-efficacy levels among
rural cancer patients who received non-medical supportive services from the CRCMC.

The investigators therefore concluded that CP and Tele-CP are acceptable, feasible, and
viable interventions to compare in a prospective randomized, controlled trial in Mendocino
County. The investigators were also able to conclude that the Decision Self Efficacy was a
suitable primary outcome measure from both the scientific and community viewpoints.

This study is a non-inferiority design which is used in situations where an effective
treatment has already been established, in this case in-person CP. The goal is to prove,
statistically, that another treatment (Tele-CP) is as effective as the established one,
within a predetermined margin of non-inferiority. We will therefore conduct a randomized,
controlled trial of non-inferiority between Tele-CP and in-person CP. The outcomes include
decisional self-efficacy, anxiety, decisional conflict, disease-related quality of life,
adherence to visits and treatments, intervention costs to the patient and resource center as
well as physician satisfaction and perception of the decision process.

Approximately 90 Mendocino patients are diagnosed every year with new or locally recurrent
breast cancer. An average of 75 breast cancer patients per year become clients of the
CRCMC, in that they receive non-medical supportive services from this agency. For example,
resource center clients are matched with a "buddy" who is a survivor of a similar condition
and is trained to provide emotional support. Clients also use the resource center library
and attend support groups. In the past, they have been offered in-person CP.

Once our study begins, all resource center clients diagnosed with stage 0, 1, 2, 3, or 4
breast cancer and who are scheduled for a decision making appointment with a surgeon or
oncologist will be asked to participate. Based on updated preliminary data (from the
resource center's 2007 records), the investigators will require 58 subjects over the study
period in order to make the primary analysis of the study scientifically and statistically
valid, although we will continuing accruing up to 116 patients in order to conduct
secondary, exploratory, subset analyses. Clients who consent to participate in our study
will be randomly assigned to Tele-CP or in-person CP. A resource center staff member
(Consultation Planner or "CPer") will use the assigned method (CP or Tele-CP) to help the
patients prepare a list of questions for their surgeon or oncologist. Before and after the
CP or Tele-CP session and their doctor's appointment, clients will be asked to complete
short surveys describing their confidence, anxiety, confusion, quality of life, and costs to
them of doing the CP session (e.g. travel time). From these surveys, as well as other
records, we will determine whether Tele-CP is as effective as in-person CP, and whether it
was more convenient and less costly.

Time 0:

- When a patient with breast cancer contacts CRCMC for information or support, the CRCMC
staff will ask the client to complete the standard CRCMC Client Intake Form. Staff
will then offer CP and inquire about the client's potential interest in participating
in the study. If the client is a monolingual Spanish speaker, the resource center staff
will enlist one of the designated translators to assist with the communication and
consent process, utilizing our UCSF CHR approved Spanish Consent Form. If the client
has any potential interest in study participation, she will then be referred to a
member of the research team. The client will also be given a copy of the UCSF CHR
approved study consent form for their review.

- A member of the research team will review the study protocol with the CRCMC client and
proceed with the informed consent process.

- For frontier clients (living in extremely remote areas), the consent process will be
initiated on the phone with a member of the research team, and a copy of the consent
form will be mailed, faxed, or emailed to the subject. After the subject has had a
chance to read and review the consent, the research team member will then address (via
telephone) all questions or concerns they may have. If the subject wishes to proceed
with the study, she will then sign the consent and forward it back to the research team
member by fax or US mail.

- For subjects who can easily be met in person and do not have transportation challenges,
a research team member will meet with each subject and complete the consent process in
person.

Each consent process will be completed pursuant to all UCSF, State and Federal Guidelines
for the Protection of Human Subjects. No study procedures will be initiated until after the
consent process is complete and the subject signs the study consent form. A copy of the
consent will be given to each subject. A copy of these documents will also be placed in the
subject's CRCMC client file.

This trial will take place at the inland and coastal offices of the CRCMC located in Ukiah
and Mendocino. Interventions will take place by telephone in one study arm, and at a
resource center office site (Ukiah or Mendocino, depending on which is closer to the client
domicile) in the other study arm. Patients randomized to the resource center arm, who cannot
arrange for transport, will be driven by a resource center staff member.

Time 1:

• After an informed consent is obtained, a research team member will then initiate the study
protocol procedures, obtain random assignment and schedule the patient for the appropriate
CP intervention.

Time 2:

• The Consultation Planner (CPer, i.e. study interventionist) will meet with the client (and
translators if necessary) either at the resource center or over the telephone via conference
call. The CPer will administer the baseline surveys in-person or by phone, then the CPer
will administer CP, and finally, once the participant has received a printed copy of the CP,
the CPer will administer post-CP surveys. The CPer will audiorecord this session whether it
takes place in person or by telephone. Participants who receive Tele-CP will receive a copy
of the printed CP either by mail, fax, email, or in-person. Consistent with resource center
practices, during the Tele-CP call the CPer will arrange a mutually convenient time to meet
with the participant either by phone or in person to review the printed CP. The Post-CP
surveys will be administered at this time.

Time 3:

- The CPer, (and translator if necessary) will accompany the patient to her doctor's
appointment with the specialist. The CPer will audiorecord the visit (patients will be
mailed a copy of the audiorecording within a week), and administer post-visit surveys
immediately at the conclusion of the appointment. The subjects will also receive a copy
of the CPer notes for their review and files.

- Because the investigators are incorporating a survey for clinicians to complete after
the consultation, the investigators have also included a Physician Consent Form for the
study. A research team member will also provide to each participating clinician a copy
of the study consent form and review the study with each of these subjects. An
informed consent will be completed with each clinician. A copy of the consent
(including the Experimental Subject's Bill of Rights) will be given to each physician.
At the start of the study, the investigators will approach all Mendocino oncologists
and surgeons who see breast cancer patients to determine their willingness to
participate.

- Note: This Physician consent process will be completed pursuant to all UCSF, State and
Federal Guidelines for the Protection of Human Subjects. No study procedures will be
initiated until after the consent process is complete and the physician signs the study
consent form. A copy of the consent (including the Experimental Subject's Bill of
Rights) will be given to these subjects.

Time 4:

Six months following the physician consultation, the a research team member will contact the
client (and translator if needed) to complete the 6 month surveys. At this time, a copy of
the participant's current CRCMC Client Intake form will be added to the study file.