Stage I Breast CancerNCT03198286
Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors
A study testing Informational Intervention in people with Stage I Breast Cancer and Stage I Cervical Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 sites in United States.
Trial summary
This pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Breast Cancer, Stage I Cervical Cancer, Stage I Ovarian Cancer
- What is being tested?
- Informational Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2015to 31 Oct 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
- Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
- Prospective study: Able to understand and read English
- Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
- Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)
Who cannot join
- Women who are pregnant
- Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Reading Hospital
Reading, Pennsylvania, 19602
About this study
Official title: A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System
This pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.
Read the detailed description
PRIMARY OBJECTIES:
- To evaluate the feasibility of using the Carevive Survivor Care Planning System (SCPS) during the follow-up visit for breast oncology survivors treated in a university cancer center or a community medical center.
II. To evaluate survivors' perceptions of the usability of the Carevive technology.
III. To evaluate their perceptions of the acceptability (perception of benefit) of the treatment summary and survivor care plan.
SECONDARY OBJECTIVES:
- Examine the psychometrics of surveys developed for this research. II. Compare participants' perceptions of the care received under the Carevive system with clinician documentation.
III. Compare clinician documentation of care received by this sample with documentation of care provided for historical controls at each site.
- Conditions
- Stage I Breast Cancer, Stage I Cervical Cancer, Stage I Ovarian Cancer, Stage I Uterine Corpus Cancer, Stage IA Breast Cancer, Stage IA Cervical Cancer
- Being tested
- Informational Intervention
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive treatment summary and survivor care plan
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (survivor care plan, survey) | Experimental | Patients receive a customized treatment summary and survivor care plan via the Carevive Survivor Care Planning System and review it during their follow-up visit. Patients also complete a survey on a tablet computer over 10-20 minutes before and after their follow-up visit. Receives: Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation will calculated to identify low-score items indicating problems that need to be addressed.
Feasibility information will be auto-generated by the Carevive system.
Measured: Up to 1 year
Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
Survivor reported outcomes will be evaluated.
Measured: Up to 1 month
Patient reported activation as measured by the Patient Activation Survey
Survivor reported outcomes will be evaluated.
Measured: Up to 1 month
Patient reported health behavior as measured by the Health Behavior Survey
Survivor reported outcomes will be evaluated.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Aug 2015
- Primary completion1 Aug 2015
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Breast CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Barsevick, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198286
- Sponsor's protocol ID
- 15P.046
- Other IDs
- JT 7206
- Status last verified
- Apr 2025
- First submitted
- 19 May 2017
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Clinical Implementation of the Carevive Survivor Care Planning System
- ClinicalTrials.gov ID
- NCT03198286
- Acronym / sponsor ID
- 15P.046
- Conditions
- Stage I Breast Cancer, Stage I Cervical Cancer, Stage I Ovarian Cancer, Stage I Uterine Corpus Cancer, Stage IA Breast Cancer, Stage IA Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 26 Jun 2017 (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 pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.
Detailed description
PRIMARY OBJECTIES:
- To evaluate the feasibility of using the Carevive Survivor Care Planning System (SCPS) during the follow-up visit for breast oncology survivors treated in a university cancer center or a community medical center.
II. To evaluate survivors' perceptions of the usability of the Carevive technology.
III. To evaluate their perceptions of the acceptability (perception of benefit) of the treatment summary and survivor care plan.
SECONDARY OBJECTIVES:
- Examine the psychometrics of surveys developed for this research. II. Compare participants' perceptions of the care received under the Carevive system with clinician documentation.
III. Compare clinician documentation of care received by this sample with documentation of care provided for historical controls at each site.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (survivor care plan, survey) | Experimental | Other: Informational InterventionPatients receive a customized treatment summary and survivor care plan via the Carevive Survivor Care Planning System and review it during their follow-up visit. Patients also complete a survey on a tablet computer over 10-20 minutes before and after their follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
- Prospective study: individuals will have pathologically confirmed breast cancer (stages I-III)
- Prospective study: Able to understand and read English
- Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
- Retrospective chart review: Individuals will have pathologically confirmed breast cancer or gynecological (GYN) malignancies including uterine, ovarian, or cervical cancers, stages I-III; treated in the previous two years (2013-2014)
Key exclusion criteria (2 listed)
- Women who are pregnant
- Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts
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 |
|---|---|---|
| Informational InterventionReceive treatment summary and survivor care plan | Other | Supportive care (survivor care plan, survey) |
Primary outcome
Standard deviation will calculated to identify low-score items indicating problems that need to be addressed.
Time frame: Up to 1 year
Feasibility information will be auto-generated by the Carevive system.
Patient reported knowledge and confidence as measured by the Knowledge and Confidence Survey
Time frame: Up to 1 month
Survivor reported outcomes will be evaluated.
Patient reported activation as measured by the Patient Activation Survey
Time frame: Up to 1 month
Survivor reported outcomes will be evaluated.
Patient reported health behavior as measured by the Health Behavior Survey
Time frame: Up to 1 month
Survivor reported outcomes will be evaluated.
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 29 Apr 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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.
Andrea Barsevick, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention in people with Stage I Breast Cancer and Stage I Cervical Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 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 5 inclusion and 2 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Standard deviation will calculated to identify low-score items indicating problems that need to be addressed. (time frame: Up to 1 year). 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 29 Apr 2025.