Clinical trial NCT01419210: Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer
Official title: A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Complementary Medicine
Traditional Medicine
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2011-08-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out if complementary and alternative medicines (CAM) should be included with traditional therapy for women with ovarian cancer. Some of the alternative medicines include non-traditional drug and herbal therapies along with dietary and nutritional strategies. Only a few of these alternative medicines have been tested with women with ovarian cancer.

Detailed description: The study will be offered to women with ovarian cancer who are receiving care at the Gynecologic Oncology Clinic at H. Lee Moffitt Cancer Center. Prospective candidates, identified via chart review, will receive a mailing that describes and invites them to be screened for eligibility. Potential participants seen in the clinic will also be approached and invited to participate.

The informed consent process and pretesting will take place in the clinic, with exceptions made as needed for women who prefer to complete documents at home.

The intervention, which will consist of four educational CAM sessions, will be held on site in a private room at Moffitt Cancer Center. Immediately before and after each session, we will administer a brief on-site pre- and post-test. Upon completion of the intervention, participants will be asked to complete a post-test on site or at home, depending on their preference. Follow-up telephone calls will be made to the participants at 8 weeks after the last session.

Pre- and post-test measures will focus on quality of life, prior use of CAM therapies, topic preferences, knowledge gained from the presentations, changed intentions and behaviors associated with CAM, and satisfaction with the program.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of ovarian cancer
* An Eastern Cooperative Oncology Group (ECOG) score of 2 or less with a life expectancy of at least 12 months
* A patient being treated by a gynecologic oncologist in the Center for Women's Oncology
* Ability to read, understand, and sign the informed consent form
* Ability to read, write and understand English, which will be the language used in the materials and oral presentations
* Willingness to complete pre-test and post-test questionnaires
* Willingness to complete brief questionnaires at each session
* Willingness to participate in one follow-up telephone interview at 8 weeks after the final session
* Willingness to participate in four sessions that take place at Moffitt Cancer Center
* Access to transportation, with the ability to travel to and from Moffitt to participate in the sessions

Primary outcomes:
measure: Number of Participants Interested in Complementary and Alternative Medicines (CAM)
timeFrame: Average of 18 Weeks
Secondary outcomes:
measure: Contingency Table
timeFrame: Average of 18 Weeks
measure: Number of Participants Reporting They Were Influenced by the Education Sessions
timeFrame: Average of 18 Weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Robert Wenham, M.D.
role: PRINCIPAL_INVESTIGATOR
References: