Ovarian NeoplasmPOSTCARE-ONCT05752448
Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)
A study testing POSTCare Survivorship transition process in people with Ovarian Neoplasm and Depressive Symptoms, run by Baylor College of Medicine at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm, Depressive Symptoms, Quality of Life
- What is being tested?
- POSTCare Survivorship transition process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2023to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Admission to hospice at the completion of treatment for ovary cancer
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UT Southwestern Parkland Health and Hospital System
Dallas, Texas, 75235
Carolina Salmeron, 713-500-0147, Carolina.Salmeron@uth.tmc.edu
- Recruiting
Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center
Houston, Texas, 77030
Lilian Moraes de Vasconcelos, 713-798-4785, Lilian.MoraesdeVasconcelos@bcm.edu
- Recruiting
Harris Health Smith Clinic
Houston, Texas, 77054
Lilian Moraes de Vasconcelos, 713-798-4785, Lilian.MoraesdeVasconcelos@bcm.edu
About this study
Official title: POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer
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.
Read the detailed description
Study Design We will conduct a 2-arm randomized controlled trial to evaluate the impact of a telehealth delivered survivorship transition care process. Ovarian cancer survivors (120) will be randomly allocated to receive survivorship care either using the POSTCare Process or standard of care. Study design and reporting will be in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist. We will use quantitative and qualitative methodologies in a concurrent triangulation mixed methods design utilizing qualitative data to augment our interpretation of quantitative data. Outcomes will be collected at baseline, 12 weeks and 24 weeks, with the primary outcome being quality of life assessment at 12 weeks.
Sample Size We will enroll 120 women completing primary treatment for Stage 2-4 ovarian cancer from 3 urban gynecologic oncology clinics located in the Southern United States. Participants will have received some combination of surgery, chemotherapy, radiation therapy, and biologics. Continued maintenance therapy is not an exclusion factor. Aim 1 proposes to implement a randomized controlled trial (RCT) devised to compare QOL measures among ovarian cancer patient randomized to receive usual care versus the POSTCare survivorship care transition program. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QOL survey will be collected at baseline as well as 12 and 24 weeks after the initial course of adjuvant chemotherapy. The primary endpoint will be the 12-week survey. We expect to observe a mean 12-week FACT-O score of 116 with standard deviation of 20 for women receiving usual care. The sample size of N=120 patients provides at least 80% power to detect a 7% increase in the mean FACT-O score for women randomized to the POSTCare survivorship care intervention. This is sufficient to ascertain a minimally important difference of 8 points.
Recruitment and Setting We will recruit participants from Gynecologic Oncology practices at 3 clinic settings in Texas: One safety net practice located in Dallas, one safety net practice located in Houston, and one faculty group practice located in Houston. Cumulatively the sites serve approximately 120 eligible patients per year and ensure a diverse population can be recruited during the 24-month recruitment period. 120 women will be recruited. Sixty participants will be randomly assigned to the intervention group and receive care using the POSTCare Process and 60 will be randomly assigned to the control group. It is anticipated that our study sample will reflect the ethnic and racial diversity of our clinical settings.
- Conditions
- Ovarian Neoplasm, Depressive Symptoms, Quality of Life
- Being tested
- POSTCare Survivorship transition process
- Keywords
- Ovarian Cancer, Survivorship, Cancer Survivor, Depression, Palliative Care, Quality of Life
- Medical subject headings
- Ovarian Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSTCare Survivorship transition processBehavioural
Survivorship coaching intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group received care Using POSTCare process Receives: Behavioral: POSTCare Survivorship transition process |
| Usual Care | No intervention | Group received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (4)
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.
Measured: 24 weeks
Recurrence Fear
Fear of Cancer Recurrence measured by Fear of Cancer Recurrence Inventory Short Form. Range 0-36; higher score indicates higher fear of cancer recurrence.
Measured: 12 and 24 weeks
Depressive Symptom Burden
Depression measured by the Patient Health Questionnaire - 9 . Range 0-27; higher score indicates greater depressive symptom burden.
Measured: 12 and 24 weeks
Symptom Burden
Symptom Burden measured by The M.D. Anderson Symptom Inventory. Range is 1-130; higher score indicates greater symptom burden
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Oct 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial double blinded
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, The University of Texas Health Science Center, Houston, University of Texas Southwestern Medical Center, University of Texas at Austin
- Responsible party
- Principal investigator, Elizabeth A Kvale, Baylor College of Medicine
- Investigators
- Elizabeth Kvale, MD,MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752448
- Sponsor's protocol ID
- H-52939
- Acronym
- POSTCARE-O
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38335019
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05752448
- Acronym / sponsor ID
- POSTCARE-O / H-52939
- Conditions
- Ovarian Neoplasm, Depressive Symptoms, Quality of Life
- Keywords
- Ovarian Cancer, Survivorship, Cancer Survivor, Depression, Palliative Care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, The University of Texas Health Science Center, Houston, University of Texas Southwestern Medical Center, University of Texas at Austin
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design We will conduct a 2-arm randomized controlled trial to evaluate the impact of a telehealth delivered survivorship transition care process. Ovarian cancer survivors (120) will be randomly allocated to receive survivorship care either using the POSTCare Process or standard of care. Study design and reporting will be in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist. We will use quantitative and qualitative methodologies in a concurrent triangulation mixed methods design utilizing qualitative data to augment our interpretation of quantitative data. Outcomes will be collected at baseline, 12 weeks and 24 weeks, with the primary outcome being quality of life assessment at 12 weeks.
Sample Size We will enroll 120 women completing primary treatment for Stage 2-4 ovarian cancer from 3 urban gynecologic oncology clinics located in the Southern United States. Participants will have received some combination of surgery, chemotherapy, radiation therapy, and biologics. Continued maintenance therapy is not an exclusion factor. Aim 1 proposes to implement a randomized controlled trial (RCT) devised to compare QOL measures among ovarian cancer patient randomized to receive usual care versus the POSTCare survivorship care transition program. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QOL survey will be collected at baseline as well as 12 and 24 weeks after the initial course of adjuvant chemotherapy. The primary endpoint will be the 12-week survey. We expect to observe a mean 12-week FACT-O score of 116 with standard deviation of 20 for women receiving usual care. The sample size of N=120 patients provides at least 80% power to detect a 7% increase in the mean FACT-O score for women randomized to the POSTCare survivorship care intervention. This is sufficient to ascertain a minimally important difference of 8 points.
Recruitment and Setting We will recruit participants from Gynecologic Oncology practices at 3 clinic settings in Texas: One safety net practice located in Dallas, one safety net practice located in Houston, and one faculty group practice located in Houston. Cumulatively the sites serve approximately 120 eligible patients per year and ensure a diverse population can be recruited during the 24-month recruitment period. 120 women will be recruited. Sixty participants will be randomly assigned to the intervention group and receive care using the POSTCare Process and 60 will be randomly assigned to the control group. It is anticipated that our study sample will reflect the ethnic and racial diversity of our clinical settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial double blinded
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: POSTCare Survivorship transition processGroup received care Using POSTCare process |
| Usual Care | No intervention | –Group received usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Admission to hospice at the completion of treatment for ovary cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSTCare Survivorship transition processSurvivorship coaching intervention | Behavioural | Intervention group |
Primary outcome
Quality of Life by FACT-O
Time frame: 12 Weeks
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.
4 secondary outcomes
Quality of Life by FACT-O
Time frame: 24 weeks
Recurrence Fear
Time frame: 12 and 24 weeks
Depressive Symptom Burden
Time frame: 12 and 24 weeks
Symptom Burden
Time frame: 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 38335019Kvale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Kvale, MD,MPH principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POSTCare Survivorship transition process in people with Ovarian Neoplasm and Depressive Symptoms, run by Baylor College of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimrah Saleem, MPH (713-798-2272, nsaleem@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life by FACT-O (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.