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

NCT02082470 | Completed DMC

• 3 other identifiers: 14001NCI-2014-00423P30CA033572
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Infrastructure for a larger comparative intervention study

  2 months

Study Arms (2)

Arm I (standard post-treatment)

ACTIVE COMPARATOR

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

Other: active surveillance; Other: questionnaire administration

Arm II (survivorship care planning)

EXPERIMENTAL

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

Other: follow-up care; Other: questionnaire administration

Interventions

follow-up care OTHER

Undergo survivorship care planning

Arm II (survivorship care planning)

active surveillance OTHER

Undergo cancer surveillance

Arm I (standard post-treatment)

questionnaire administration OTHER

Ancillary studies

Arm I (standard post-treatment); Arm II (survivorship care planning)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Aftercare; Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care

Study Officials

• Virginia Sun

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: April 11, 2014
• Primary Completion: September 26, 2017
• Study Completion: September 26, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

US (1)