CancerNCT02405819
Patient and Provider Initiated Survivorship Care Planning
A study testing 'My Care Plan' and 'Survivorship Care Plan Builder' in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- 'My Care Plan' and 'Survivorship Care Plan Builder'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Feb 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
- Have you completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
- What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)
Who cannot join
- 1. Do you show any evidence of disease?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Patient and Provider Initiated Survivorship Care Planning: a Randomized Pilot Study
Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. The results of this study will be used to (1) provide an initial assessment of the two survivorship care planning tools and (2) inform the design and conduct of a larger study.
Read the detailed description
Background/Rationale: In a 2005 report 'From Cancer Patient to Cancer Survivor: Lost in Transition', the Institute of Medicine recommended that cancer patients completing treatment receive a summary of the care received and a plan outlining follow-up care needs. Taken together these materials are referred to as a 'Survivorship Care Plan', or SCPs. Based on this recommendation from the IOM, a number of organizations developed survivorship care plan templates. Two of these templates, 'Survivorship Care Plan Builder' and 'My Care Plan,' were developed by Journey Forward, a collaboration among the National Coalition for Cancer Survivorship, UCLA Cancer Survivorship Center, Oncology Nursing Society, WellPoint, Inc., and Genentech (http://journeyforward.org/). These tools are available free of charge to those wishing to use them. As the time and effort required to complete SCP documents have been found to be barriers to implementation, this study aims to explore the use of these two tools.
Research Questions:
- What processes are undertaken to implement survivorship care planning?
- How do these processes differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
- What is the feasibility of implementing survivorship care planning?
- Does the feasibility differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
- What is the value of survivorship care planning to both patients and providers?
- Does the value differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
Study Design: This is a pilot randomized study. Cancer patients completing acute treatment with a participating provider will be randomized to either the patient-initiated My Care Plan tool or provider-initiated Survivorship Care Plan Builder. The investigators will describe and compare how each tool is implemented in practice, the feasibility of completing each tool, and the value of the tools to patients and providers. The study will use quantitative and qualitative measures of implementation, feasibility, and value.
- Conditions
- Cancer
- Being tested
- 'My Care Plan', 'Survivorship Care Plan Builder'
- Keywords
- Cancer, Oncology, Survivorship, Care, Plan
- Medical subject headings
- Neoplasms, Neuroaxonal Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'My Care Plan'Other
'My Care Plan' is a patient-initiated survivorship care planning tool.
'Survivorship Care Plan Builder'Other
'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.
| Study group | Role | What they receive |
|---|---|---|
| Patient Directed | Other | We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The research team will direct patients to their assigned condition by providing a hand-out directing them to the planning tool. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended. Receives: Other: 'My Care Plan' |
| Clinician Directed | Other | We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The provider will be provided a hand-out with their patient's assigned condition and is responsible for implementing the survivorship care plan process. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended. Receives: Other: 'Survivorship Care Plan Builder' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient in receipt of a complete survivorship care plan
As this study explores the feasibility of the survivorship care planning process, the primary outcome measure is whether or not the patient receives a complete survivorship care plan.
Measured: 16 weeks
Secondary outcomes (2)
Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool
The change in score on the CaSUN tool will be used to asses the value of survivorship care planning.
Measured: 16 weeks
Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool
The change in score on the PLANS tool will be used to asses the value of survivorship care planning.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., WellPoint, Inc.
- Responsible party
- Sponsor
- Investigators
- Katherine C Smith, Ph.D., Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405819
- Sponsor's protocol ID
- J14178
- Other IDs
- IRB00057614
- Status last verified
- Nov 2015
- First submitted
- 13 Mar 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Griggs, J. et al. PLANS ("Preparing for Life as a New Survivor")
Hodgkinson K, Butow P, Hunt GE, Pendlebury S, Hobbs KM, Lo SK, Wain G. The development and evaluation of a measure to assess cancer survivors' unmet supportive care needs: the CaSUN (Cancer Survivors' Unmet Needs measure). Psychooncology. 2007 Sep;16(9):796-804. doi: 10.1002/pon.1137.
PubMed 17177268Sprague BL, Dittus KL, Pace CM, Dulko D, Pollack LA, Hawkins NA, Geller BM. Patient satisfaction with breast and colorectal cancer survivorship care plans. Clin J Oncol Nurs. 2013 Jun;17(3):266-72. doi: 10.1188/13.CJON.17-03AP.
PubMed 23722604Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.
PubMed 28410187
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Provider Initiated Survivorship Care Planning: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02405819
- Acronym / sponsor ID
- J14178
- Conditions
- Cancer
- Keywords
- Cancer, Oncology, Survivorship, Care, Plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Genentech, Inc., WellPoint, Inc.
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Apr 2015 (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.
Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. The results of this study will be used to (1) provide an initial assessment of the two survivorship care planning tools and (2) inform the design and conduct of a larger study.
Detailed description
Background/Rationale: In a 2005 report 'From Cancer Patient to Cancer Survivor: Lost in Transition', the Institute of Medicine recommended that cancer patients completing treatment receive a summary of the care received and a plan outlining follow-up care needs. Taken together these materials are referred to as a 'Survivorship Care Plan', or SCPs. Based on this recommendation from the IOM, a number of organizations developed survivorship care plan templates. Two of these templates, 'Survivorship Care Plan Builder' and 'My Care Plan,' were developed by Journey Forward, a collaboration among the National Coalition for Cancer Survivorship, UCLA Cancer Survivorship Center, Oncology Nursing Society, WellPoint, Inc., and Genentech (http://journeyforward.org/). These tools are available free of charge to those wishing to use them. As the time and effort required to complete SCP documents have been found to be barriers to implementation, this study aims to explore the use of these two tools.
Research Questions:
- What processes are undertaken to implement survivorship care planning?
- How do these processes differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
- What is the feasibility of implementing survivorship care planning?
- Does the feasibility differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
- What is the value of survivorship care planning to both patients and providers?
- Does the value differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
Study Design: This is a pilot randomized study. Cancer patients completing acute treatment with a participating provider will be randomized to either the patient-initiated My Care Plan tool or provider-initiated Survivorship Care Plan Builder. The investigators will describe and compare how each tool is implemented in practice, the feasibility of completing each tool, and the value of the tools to patients and providers. The study will use quantitative and qualitative measures of implementation, feasibility, and value.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Directed | Other | Other: 'My Care Plan'We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The research team will direct patients to their assigned condition by providing a hand-out directing them to the planning tool. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended. |
| Clinician Directed | Other | Other: 'Survivorship Care Plan Builder'We will collect baseline data, including sociodemographic information for the patients and an assessment of each patient's baseline supportive care needs and knowledge about survivorship care. Sociodemographic information will be self completed. All other data collection will be interviewer administered. The instruments used at baseline and follow-up are adapted from previously published surveys (Hodgkinson et al, 2007; Sprague et al, 2013; Griggs et al). The provider will be provided a hand-out with their patient's assigned condition and is responsible for implementing the survivorship care plan process. After 2 months, we will re-contact all randomized patients to determine whether the survivorship care planning occurred as intended. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
- Have you completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
- What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)
Key exclusion criteria (1 listed)
- 1. Do you show any evidence of disease?
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 |
|---|---|---|
| 'My Care Plan''My Care Plan' is a patient-initiated survivorship care planning tool. | Other | Patient Directed |
| 'Survivorship Care Plan Builder''Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool. | Other | Clinician Directed |
Primary outcome
Patient in receipt of a complete survivorship care plan
Time frame: 16 weeks
As this study explores the feasibility of the survivorship care planning process, the primary outcome measure is whether or not the patient receives a complete survivorship care plan.
2 secondary outcomes
Change in score for the CaSUN (Cancer Survivors' Unmet Needs) assessment tool
Time frame: 16 weeks
Change in score on the PLANS (Preparing for Life as a New Survivor) assessment tool
Time frame: 16 weeks
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 21 Apr 2016.
- BackgroundGriggs, J. et al. PLANS ("Preparing for Life as a New Survivor")
- Background: PubMed 17177268Hodgkinson K, Butow P, Hunt GE, Pendlebury S, Hobbs KM, Lo SK, Wain G. The development and evaluation of a measure to assess cancer survivors' unmet supportive care needs: the CaSUN (Cancer Survivors' Unmet Needs measure). Psychooncology. 2007 Sep;16(9):796-804. doi: 10.1002/pon.1137.
- Background: PubMed 23722604Sprague BL, Dittus KL, Pace CM, Dulko D, Pollack LA, Hawkins NA, Geller BM. Patient satisfaction with breast and colorectal cancer survivorship care plans. Clin J Oncol Nurs. 2013 Jun;17(3):266-72. doi: 10.1188/13.CJON.17-03AP.
- Derived from this study: PubMed 28410187Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.
- Journey Forward is a cancer survivorship program for healthcare providers and patients who have finished active treatment.Link 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.
Katherine C Smith, Ph.D. principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'My Care Plan' and 'Survivorship Care Plan Builder' in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 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 21 Apr 2016. 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?
Patient in receipt of a complete survivorship care plan (time frame: 16 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 NCT02405819, which also lists 4 linked publications.
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 21 Apr 2016.