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Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082470
First Posted: March 10, 2014
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  Purpose
This pilot clinical trial studies survivorship care planning in supporting quality of life in ovarian cancer survivors following primary treatment. Survivorship care plans have the potential to empower patients and provide them with a plan of care following treatments. Survivorship care planning may support patient's overall well-being and quality of life after treatment of ovarian cancer.

Condition Intervention
Cancer Survivor Stage IA Ovarian Epithelial Cancer Stage IB Ovarian Epithelial Cancer Stage IC Ovarian Epithelial Cancer Stage IIA Ovarian Epithelial Cancer Stage IIB Ovarian Epithelial Cancer Stage IIC Ovarian Epithelial Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIC Ovarian Epithelial Cancer Other: follow-up care Other: active surveillance Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Percentage of attrition [ Time Frame: 2 months ]
    Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate. Descriptive statistics will also be presented for percentage of attrition (based on number of patients who failed to complete the 2 months study. Reasons for attrition will also be documented.

  • Total retention [ Time Frame: 2 months ]
    Descriptive statistics will be presented for the total retention.

  • Recruitment rates [ Time Frame: 2 months ]
    Important information regarding recruitment for the subsequent larger trial will be provided including estimates of the number of contacts needed to produce a qualified participant, the percentage of those who are qualified and agree to participate, and a retention rate.

  • Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form [ Time Frame: 2 months ]
    Quantitative and qualitative descriptive statistics will be analyzed using descriptive statistics and content analysis methods to determine satisfaction with the timing, content, and delivery of the intervention.


Secondary Outcome Measures:
  • Infrastructure for a larger comparative intervention study [ Time Frame: 2 months ]
    The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.


Enrollment: 14
Study Start Date: April 11, 2014
Study Completion Date: September 26, 2017
Primary Completion Date: September 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (standard post-treatment)
Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.
Other: active surveillance
Undergo cancer surveillance
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (survivorship care planning)
Participants complete survivorship care planning in close collaboration with treating oncologists.
Other: follow-up care
Undergo survivorship care planning
Other: questionnaire administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.

SECONDARY OBJECTIVES:

I. To develop the infrastructure and strategy for a larger comparative intervention study (National Cancer Institute [NCI] R01).

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.

ARM II: Participants complete survivorship care planning in close collaboration with treating oncologists.

After completion of study treatment, participants are followed up at 2 months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of stage I, II, or III ovarian cancer
  • Ability to read or understand English
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082470


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Virginia Sun City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02082470     History of Changes
Other Study ID Numbers: 14001
NCI-2014-00423 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
14001 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Submitted: March 6, 2014
First Posted: March 10, 2014
Last Update Posted: September 28, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type