Trial Information

NURSE-DELIVERED WRITE SYMPTOMS© vs. SELF-DIRECTED WRITE SYMPTOMS© vs. CARE AS USUAL FOR OPTIMAL SYMPTOM MANAGEMENT FOR WOMEN WITH RECURRENT OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

OBJECTIVES:

Primary

- Compare the efficacy of nurse-delivered WRITE Symptoms© and self-directed WRITE
Symptoms© vs usual care interventions in improving target symptom representations
(i.e., decreases in symptom severity, symptom-related distress, and symptom
consequences as measured by the Symptom Representation Questionnaire [SRQ]) in patients
with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

Secondary

- Compare the efficacy of nurse-delivered WRITE Symptoms© vs self-directed WRITE
Symptoms© vs usual care interventions in improving target symptom representations in
these patients at 4 weeks.

- Compare the efficacy of nurse-delivered WRITE Symptoms© vs self-directed WRITE
Symptoms© vs usual care interventions in improving target symptom controllability in
these patients at 4, 8, and 12 weeks.

- Compare the efficacy of nurse-delivered WRITE Symptoms© vs self-directed WRITE
Symptoms© vs usual care interventions in improving indicators of quality of life (QOL)
of these patients as measured by the FACT-O and the CES-Depression inventory short form
at 4, 8, and 12 weeks.

- Compare the efficacy of nurse-delivered WRITE Symptoms© vs self-directed WRITE
Symptoms© vs usual care interventions in improving communication with health care
providers about symptoms, implementation of new symptom management strategies (health
care provider recommended as well as patient-initiated changes), and perceived
effectiveness of strategies (health care provider recommended as well as
patient-initiated changes) in these patients at 4, 8, and 12 weeks.

- Compare the efficacy of nurse-delivered WRITE Symptoms© vs self-directed WRITE
Symptoms© vs usual care interventions in improving patient-related barriers to symptom
management as measured by the Symptom Management Barriers Questionnaire at 4, 8, and 12
weeks.

Exploratory

- Compare trajectories of change for overall symptom severity in patients undergoing
nurse-delivered WRITE Symptoms© vs self-directed WRITE Symptoms© vs usual care
interventions using monthly assessments to explore potential long-term effects of the
WRITE Symptoms© interventions.

- Compare trajectories of change for QOL of patients undergoing nurse-delivered WRITE
Symptoms© vs self-directed WRITE Symptoms© vs usual care interventions using monthly
assessments to explore potential long-term effects of the WRITE Symptoms©
interventions.

- Compare trajectories of change for symptom severity, distress, communication, and
implementation of new strategies for non-targeted symptoms in patients undergoing
nurse-delivered WRITE Symptoms© vs self-directed WRITE Symptoms© vs usual care
interventions using monthly assessments to explore whether patients are able to
generalize the symptom management approaches taught in WRITE Symptoms© interventions to
their other non-targeted symptoms.

- Explore whether changes in symptom representations mediate changes in QOL of these
patients at 8 and 12 weeks.

- Explore whether effects of the WRITE Symptoms© interventions on primary and secondary
endpoints at 8 and 12 weeks differ based on the following patient characteristics
assessed at baseline: age, education, and ethnicity; depression as measured by the
CES-D short form; trait anxiety as measured by the STAI; optimism as measured by the
LOT-R; social support as measured by the ISEL; and symptom severity as measured by the
SRQ.

OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity
(non-Hispanic white vs Hispanic or non-white). Patients are randomized to 1 of 3
intervention arms.

- Arm I (nurse-delivered intervention): Patients are given password-protected access to
their own web-based message board to communicate with a research nurse. The nurse leads
the patient through the WRITE Symptoms© intervention module comprising representational
assessment; exploring concerns/misconceptions/gaps/confusions; creating conditions for
conceptual change; introducing new information, goal setting, and development of a
symptom management plan; and summary via asynchronous postings to the patient's message
board. Patients work through 3 selected symptoms using the nurse-delivered WRITE
Symptoms© intervention module over approximately 4 weeks. Two weeks later, the
patient's symptom management strategy and their desire to make further changes are
evaluated by additional interaction with the nurse via the message board. The nurse
will encourage the patient to try new selected strategies, continue with effective
strategies, and work with local health care providers in an ongoing process to improve
symptom management. Patients are given access to a resource guide that includes
self-care guides for 26 symptoms. They are encouraged to use the same process taught
for their 3 selected symptoms for any other symptoms that arise after the course of the
intervention.

- Arm II (self-directed intervention): Patients are given password-protected access to an
interactive web-based computer program that will lead them through a modified WRITE
Symptoms© intervention module (comprising the same elements as in arm I) without
guidance and individualized recommendations from a nurse. Patients work through 3
selected symptoms using the WRITE Symptoms© intervention module over approximately 4
weeks. Two weeks later, patients are prompted by the computer program to respond to
questions about their symptom management strategy and their desire to make further
changes. The program will generate an encouragement for the patient to try new selected
strategies, continue with effective strategies, and continue the new approach to
symptom management with local health care providers in an ongoing process to improve
symptom management. Patients are given access to a resource guide that includes
self-care guides for 26 symptoms. They are encouraged to use the same process taught
for their 3 selected symptoms for any other symptoms that arise after the course of the
intervention.

- Arm III (usual care): Patients are given password-protected access to online
questionnaires. Patients are prompted monthly to complete online questionnaires.
Patients receive standard symptom management from their local health care providers.

In all arms, patients complete online questionnaires to assess outcome measures at baseline,
at 4, 8, and 12 weeks, and then every 4 weeks for 1 year.