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

City of Hope

Status: Completed

Conditions: Stage IIIA Ovarian Epithelial Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IA Ovarian Epithelial Cancer; Stage IC Ovarian Epithelial Cancer; Cancer Survivor; Stage IIIB Ovarian Epithelial Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IB Ovarian Epithelial Cancer; Stage IIA Ovarian Epithelial Cancer

Treatments: Other: follow-up care; Other: active surveillance; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02082470

14001 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2014-00423 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Arm I (standard post-treatment)

Active Comparator group

Description:

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

Treatment:

Other: active surveillance

Other: questionnaire administration

Arm II (survivorship care planning)

Experimental group

Description:

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

Treatment:

Other: questionnaire administration

Other: follow-up care