Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer

NCT01419210 | Completed

• 1 other identifier: MCC-15221
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Complementary Medicine; Traditional Medicine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Interested in Complementary and Alternative Medicines (CAM)

  Aim 1, proportions of participants who attend the education sessions (with 95% confidence intervals) will be calculated for each of the 5 CAM therapies. Mean (along with SD) score will be calculated for each therapy.

  Average of 18 Weeks

Secondary Outcomes (2)

• Contingency Table

  Average of 18 Weeks

• Number of Participants Reporting They Were Influenced by the Education Sessions

  Average of 18 Weeks

Study Arms (1)

Complementary and Alternative Medicine (CAM) therapies

EXPERIMENTAL

This pilot program attends to the need for appropriate patient-centered interventions that integrate CAM with traditional care to maximize both quantity and QOL for women with ovarian cancer.

Other: Pre-study Questionnaire; Other: Educational Presentations; Other: CAM Therapies; Other: Post-study Questionnaire

Interventions

Pre-study Questionnaire OTHER

Assess the interest level for various CAM topics through feedback received from the study participants

Complementary and Alternative Medicine (CAM) therapies

Educational Presentations OTHER

Attend a two-hour presentation each week for four weeks

Complementary and Alternative Medicine (CAM) therapies

CAM Therapies OTHER

Integrate the CAM topics of highest interest into participant's regular care

Complementary and Alternative Medicine (CAM) therapies

Post-study Questionnaire OTHER

Examine the data to see if it supports recommending a larger, multi-site, integrative CAM program for other women with ovarian cancer

Complementary and Alternative Medicine (CAM) therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• University of South Florida: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Robert Wenham, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)