Stage I Colon CancerNCT01741636
Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer
A study testing educational intervention, questionnaire administration and quality-of-life assessment in people with Stage I Colon Cancer and Stage I Rectal Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stage I Colon Cancer, Stage I Rectal Cancer, Stage IA Non-small Cell Lung Cancer
- What is being tested?
- educational intervention, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of stage I, II, or III CRC or NSCLC
- Able to read and understand English
- Able to read and/or understand the study protocol requirements, and provide written informed consent
- Diagnosis of CRC or NSCLC
- Within three months of completing primary treatment (surgery, chemotherapy, radiation, or chemoradiation)
- Without recurrent or new primary cancers
Who cannot join
None listed.
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: Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study
Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors
Read the detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and acceptability of an Advanced Practice Nurse (APN) driven Survivorship Care Planning (SCP) intervention for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) survivors.
SECONDARY OBJECTIVES:
- Development of the infrastructure and strategy for a larger comparative intervention study.
OUTLINE:
Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.
- Conditions
- Stage I Colon Cancer, Stage I Rectal Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Colon Cancer, Stage IIA Non-small Cell Lung Cancer
- Being tested
- educational intervention, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Undergo Survivorship Care Planning
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (survivorship plan) | Experimental | Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations. Receives: Other: educational intervention; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of attrition based on number of patients who failed to complete the two-month study
Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
Measured: 2 months
Total retention across the two month follow-up
Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
Measured: 2 months
Percentage of those who are qualified and agree to participate
Measured: 2 months
Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration
Measured: 2 months
Cost implications including hiring and training of the research staff, development of study manuals and patient education materials, research staff time, intervention supplies, and other miscellaneous costs
Measured: 2 months
Satisfaction with the timing, content, and delivery of the intervention
Quantitative and qualitative descriptive statistics will be analyzed.
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 posted5 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Colon CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01741636
- Sponsor's protocol ID
- 12342
- Other IDs
- NCI-2012-02783
- Status last verified
- Dec 2013
- First submitted
- 3 Dec 2012
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01741636
- Acronym / sponsor ID
- 12342
- Conditions
- Stage I Colon Cancer, Stage I Rectal Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Colon Cancer, Stage IIA Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Dec 2012 (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.
Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors
Detailed description
PRIMARY OBJECTIVES:
- To test the feasibility and acceptability of an Advanced Practice Nurse (APN) driven Survivorship Care Planning (SCP) intervention for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) survivors.
SECONDARY OBJECTIVES:
- Development of the infrastructure and strategy for a larger comparative intervention study.
OUTLINE:
Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (survivorship plan) | Experimental | Other: educational intervention, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed diagnosis of stage I, II, or III CRC or NSCLC
- Able to read and understand English
- Able to read and/or understand the study protocol requirements, and provide written informed consent
- Diagnosis of CRC or NSCLC
- Within three months of completing primary treatment (surgery, chemotherapy, radiation, or chemoradiation)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalUndergo Survivorship Care Planning | Other | Supportive care (survivorship plan) |
| questionnaire administrationAncillary studies | Other | Supportive care (survivorship plan) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (survivorship plan) |
Primary outcome
Percentage of attrition based on number of patients who failed to complete the two-month study
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.
Total retention across the two month follow-up
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.
Percentage of those who are qualified and agree to participate
Time frame: 2 months
Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration
Time frame: 2 months
Cost implications including hiring and training of the research staff, development of study manuals and patient education materials, research staff time, intervention supplies, and other miscellaneous costs
Time frame: 2 months
Satisfaction with the timing, content, and delivery of the intervention
Time frame: 2 months
Quantitative and qualitative descriptive statistics will be analyzed.
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 18 Dec 2013.
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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 educational intervention, questionnaire administration and quality-of-life assessment in people with Stage I Colon Cancer and Stage I Rectal 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 6 inclusion and 0 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 18 Dec 2013. 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 based on number of patients who failed to complete the two-month study (time frame: 2 months). The study lists 6 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 18 Dec 2013.