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

Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor; Stage IIIA Ovarian Epithelial Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIA Ovarian Epithelial Cancer; Stage IIB Ovarian Epithelial Cancer; Stage IIC Ovarian Epithelial Cancer; Stage IA Ovarian Epithelial Cancer; Stage IB Ovarian Epithelial Cancer; Stage IC Ovarian Epithelial Cancer
• Intervention / Treatment: Other: questionnaire administration; Other: active surveillance; Other: follow-up care

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm I (standard post-treatment); Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.	Other: questionnaire administration; Ancillary studies; Other: active surveillance; Undergo cancer surveillance
EXPERIMENTAL: Arm II (survivorship care planning); Participants complete survivorship care planning in close collaboration with treating oncologists.	Other: questionnaire administration; Ancillary studies; Other: follow-up care; Undergo survivorship care planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total retention	Descriptive statistics will be presented for the total retention.	2 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: April 11, 2014
• Primary Completion (ACTUAL): September 26, 2017
• Study Completion (ACTUAL): September 26, 2017

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (ESTIMATE): March 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 14001 (OTHER: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2014-00423 (REGISTRY: CTRP (Clinical Trial Reporting Program))