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NCT02082470 Clinical Trial

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

Cancer Survivor Clinical Trial

Official title:
Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02082470
Other study ID # 14001
Secondary ID NCI-2014-0042314
Status Completed
Phase N/A
First received March 6, 2014
Last updated September 27, 2017
Start date April 11, 2014
Est. completion date September 26, 2017

Study information
Verified date September 2017
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date September 26, 2017
Est. primary completion date September 26, 2017
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Cancer Survivor
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • 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

Intervention

Other:
• follow-up care
Undergo survivorship care planning
• active surveillance
Undergo cancer surveillance
• questionnaire administration
Ancillary studies

Locations
Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)
Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of attrition 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. 2 months
Primary Total retention Descriptive statistics will be presented for the total retention. 2 months
Primary Recruitment rates 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. 2 months
Primary Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form 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. 2 months
Secondary Infrastructure for a larger comparative intervention study The descriptive statistical estimates will be used for sample size determination for a larger subsequent study. 2 months
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