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

Primary Purpose

Cancer Survivor, Stage IA Ovarian Epithelial Cancer, Stage IB Ovarian Epithelial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
follow-up care
active surveillance
questionnaire administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard post-treatment)

Arm II (survivorship care planning)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Total retention
Descriptive statistics will be presented for the total retention.
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.
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.

Secondary Outcome Measures

Infrastructure for a larger comparative intervention study
The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.

Full Information

First Posted
March 6, 2014
Last Updated
September 27, 2017
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02082470
Brief Title
Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer
Official Title
Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 11, 2014 (undefined)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard post-treatment)
Arm Type
Active Comparator
Arm Description
Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.
Arm Title
Arm II (survivorship care planning)
Arm Type
Experimental
Arm Description
Participants complete survivorship care planning in close collaboration with treating oncologists.
Intervention Type
Other
Intervention Name(s)
follow-up care
Intervention Description
Undergo survivorship care planning
Intervention Type
Other
Intervention Name(s)
active surveillance
Intervention Description
Undergo cancer surveillance
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percentage of attrition
Description
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.
Time Frame
2 months
Title
Total retention
Description
Descriptive statistics will be presented for the total retention.
Time Frame
2 months
Title
Recruitment rates
Description
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.
Time Frame
2 months
Title
Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Infrastructure for a larger comparative intervention study
Description
The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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