Cancer SurvivorNCT02082470
Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer
A study testing follow-up care, active surveillance and questionnaire administration in people with Cancer Survivor and Stage IA Ovarian Epithelial Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cancer Survivor, Stage IA Ovarian Epithelial Cancer, Stage IB Ovarian Epithelial Cancer
- What is being tested?
- follow-up care, active surveillance and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2014to 26 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.
SECONDARY OBJECTIVES:
- 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.
- 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
- Being tested
- follow-up care, active surveillance, questionnaire administration
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up careOther
Undergo survivorship care planning
active surveillanceOther
Undergo cancer surveillance
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard post-treatment) | Active comparator | Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists. Receives: Other: active surveillance; Other: questionnaire administration |
| Arm II (survivorship care planning) | Experimental | Participants complete survivorship care planning in close collaboration with treating oncologists. Receives: Other: follow-up care; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Total retention
Descriptive statistics will be presented for the total retention.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Infrastructure for a larger comparative intervention study
The descriptive statistical estimates will be used for sample size determination for a larger subsequent study.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study start11 Apr 2014
- Primary completion26 Sep 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082470
- Sponsor's protocol ID
- 14001
- Other IDs
- NCI-2014-00423, 14001, P30CA033572
- Status last verified
- Sep 2017
- First submitted
- 6 Mar 2014
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02082470
- Acronym / sponsor ID
- 14001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2014
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 10 Mar 2014 (estimated)
- 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 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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard post-treatment) | Active comparator | Other: active surveillance, Other: questionnaire administrationParticipants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists. |
| Arm II (survivorship care planning) | Experimental | Other: follow-up care, Other: questionnaire administrationParticipants complete survivorship care planning in close collaboration with treating oncologists. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 |
|---|---|---|
| follow-up careUndergo survivorship care planning | Other | Arm II (survivorship care planning) |
| active surveillanceUndergo cancer surveillance | Other | Arm I (standard post-treatment) |
| questionnaire administrationAncillary studies | Other | Arm I (standard post-treatment), Arm II (survivorship care planning) |
Primary outcome
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.
Total retention
Time frame: 2 months
Descriptive statistics will be presented for the total retention.
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.
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.
1 secondary outcome
Infrastructure for a larger comparative intervention study
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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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. This study is not recruiting at the moment.
Virginia Sun principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follow-up care, active surveillance and questionnaire administration in people with Cancer Survivor and Stage IA Ovarian Epithelial Cancer, run by City of Hope Medical Center at 1 site 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 3 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: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of attrition (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2017.