Brief Title
Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title
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
Brief Summary
This randomized clinical trial is studying two different symptom management programs to see
how well they work compared with usual care in patients with recurrent or persistent ovarian
cancer, fallopian tube cancer, or primary peritoneal cancer. Developing a symptom management
plan may help relieve symptoms related to cancer or cancer treatment and help improve quality
of life.
Detailed Description
PRIMARY OBJECTIVE:
I. 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 OBJECTIVES:
I. 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.
II. 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.
III. 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.
IV. 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.
V. 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 OBJECTIVES:
I. 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.
II. 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.
III. 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.
IV. Explore whether changes in symptom representations mediate changes in QOL of these
patients at 8 and 12 weeks.
V. 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.
Study Type
Interventional
Primary Outcome
Symptom severity, symptom-related distress, consequences, and control of symptoms as measured by the Symptom Representation Questionnaire
Secondary Outcome
Health-related quality of life as measured by the FACT-O
Condition
Fallopian Tube Carcinoma
Intervention
Communication Intervention
Study Arms / Comparison Groups
Arm I (nurse-assisted intervention module)
Description: Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads patients through WRITE Symptoms? intervention module, with personalized support and advice. 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
485
Start Date
January 19, 2010
Primary Completion Date
January 8, 2017
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that has recurred
or persisted following primary therapy
- Active disease or current treatment are not required
- Must be experiencing ? 3 symptoms associated with ovarian cancer or cancer treatment,
including, but not limited to, any of the following:
- Abdominal bloating or cramping
- Nausea, vomiting, or diarrhea
- Constipation
- Anorexia
- Anxiety
- Depression
- Dizziness
- Drowsiness
- Dry mouth
- Fatigue
- Headaches
- Hair loss
- Hot flashes
- Memory concerns
- Mood swings
- Mouth sores
- Pain
- Peripheral neuropathies
- Sexuality concerns
- Sleep disturbances
- Shortness of breath
- Skin rash or palmar-plantar erythrodysesthesia
- Urinary problems
- Weight gain or loss
- GOG performance status 0-2
- Able to read and write English
- Access to computer and the Internet required
- Concurrent treatment on other clinical trials allowed
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Heidi Donovan, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00958698
Organization ID
GOG-0259
Secondary IDs
NCI-2011-01950
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Heidi Donovan, Principal Investigator, Gynecologic Oncology Group
Verification Date
March 2019