NCT05752448

Brief Summary

This study will enroll 120 women living with ovarian cancer following completion of initial treatment. Our objective is to test an intervention designed to provide support during the survivorship transition for this population, who live with a high degree of morbidity related to the illness and its treatment as well as a high risk of recurrence. Study participants will be randomly assigned to receive survivorship care using the POSTCare-O process or usual care. The primary outcome is quality of life at 12 weeks after intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2023Apr 2027

First Submitted

Initial submission to the registry

February 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

February 22, 2023

Last Update Submit

January 11, 2024

Conditions

Ovarian NeoplasmDepressive SymptomsQuality of Life

Keywords

Ovarian CancerSurvivorshipCancer SurvivorDepressionPalliative CareQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life by FACT-O

    Quality of life measured by Functional Assessment of Cancer Therapy - Ovarian instrument composite scorecomprised of physical, emotional, functional, social, and disease specific subscales. Scoring range 0 - 152; a higher score indicates better quality of life.

    12 Weeks

Secondary Outcomes (4)

  • Quality of Life by FACT-O

    24 weeks

  • Recurrence Fear

    12 and 24 weeks

  • Depressive Symptom Burden

    12 and 24 weeks

  • Symptom Burden

    12 and 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Group received care Using POSTCare process

Behavioral: POSTCare Survivorship transition process

Usual Care

NO INTERVENTION

Group received usual care

Interventions

POSTCare Survivorship transition processBEHAVIORAL

Survivorship coaching intervention

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females at birth have ovaries
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 2-4 ovarian cancer
  • Treated with some combination of surgery, chemotherapy, biologics, maintenance therapy
  • Within 6 months of completion of initial treatment (continued maintenance therapy okay)
  • Able to provide consent in English or Spanish

You may not qualify if:

  • Admission to hospice at the completion of treatment for ovary cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UT Southwestern Parkland Health and Hospital System

Dallas, Texas, 75235, United States

NOT YET RECRUITING

Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

Harris Health Smith Clinic

Houston, Texas, 77054, United States

RECRUITING

Related Publications (1)

  • Kvale E, Phillips F, Ghosh S, Lea J, Hoppenot C, Costales A, Sunde J, Badr H, Nwogu-Onyemkpa E, Saleem N, Ward R, Balasubramanian B. Survivorship Care for Women Living With Ovarian Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 9;13:e48069. doi: 10.2196/48069.

    PMID: 38335019DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsDepression

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBehavioral SymptomsBehavior

Study Officials

  • Elizabeth Kvale, MD,MPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimrah Saleem, MPH

CONTACT

713-798-2272nsaleem@bcm.edu

Judy Bettencourt, MPH

CONTACT

(713) 500-9527judith.l.bettencourt@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Will mask all study personnel except care provider who will not be engaged with data interpretation
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial double blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 2, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

April 15, 2027

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)