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

NCT ID: NCT02082470

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-11

Study Completion Date

2017-09-26

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (standard post-treatment)

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

Group Type ACTIVE_COMPARATOR

active surveillance

Intervention Type OTHER

Undergo cancer surveillance

questionnaire administration

Intervention Type OTHER

Ancillary studies

Arm II (survivorship care planning)

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

Group Type EXPERIMENTAL

follow-up care

Intervention Type OTHER

Undergo survivorship care planning

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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follow-up care

Undergo survivorship care planning

Intervention Type OTHER

active surveillance

Undergo cancer surveillance

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Sun

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-00423

Identifier Type: REGISTRY

Identifier Source: secondary_id

14001

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14001

Identifier Type: -

Identifier Source: org_study_id