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NCT Number: NCT02082470

Survivorship Care Planning in Improving Quality of Life in Survivors of 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.

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Key information

Conditions

Cancer Survivor Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases 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 Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up Care

Other

Undergo survivorship care planning

Active Surveillance

Other

Undergo cancer surveillance

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Percentage of attrition

    Time frame: 2 months

    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. Total retention

    Time frame: 2 months

    Descriptive statistics will be presented for the total retention.

  3. Recruitment rates

    Time frame: 2 months

    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.

  4. Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form

    Time frame: 2 months

    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 outcomes

  1. Infrastructure for a larger comparative intervention study

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2014
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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