Carcinoma, Non Small Cell LungNCT02135211
Healthy Directions After Lung Surgery Pilot
A study testing Lifestyle counseling in people with Carcinoma, Non Small Cell Lung, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Jun 2015
- 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
Patient Inclusion Criteria:
- > 21 years of age
- English speaking
- MD approval to participate in study
- Meets one of the inclusions below:
- 1. a histological diagnosis of NSCLC undergoing potentially curative treatment
- 2. OR those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules
- 3.OR patients who have had a surgical procedure for lung cancer within the last six months.
- May invite a buddy to join study with them defined as a friend, partner, adult child or sibling
Buddy Inclusion Criteria:
- ≥ 21 years of age,
- English speaking, who is invited by the subject to join as a support person (e.g., friend, partner, adult child or sibling)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Woman's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- Lifestyle counseling
- Keywords
- non-small cell lung cancer (NSCLC), multiple risk factor, lifestyle intervention, health behavior, lifestyle risk reduction, health related quality of life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Health Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | This is a single arm, quasi-experimental, pre- and post- test study design to test the feasibility and acceptability of a multiple risk factor, lifestyle intervention in patients receiving surgical treatment for lung cancer or those suspected of having lung cancer. Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.
Measured: at end of study (4 months post intervention)
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials
Measured: at end of study (4 months post intervention)
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring
Measured: at end of study (4 months post intervention
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.
Measured: at end of study (4 months post intervention)
Secondary outcomes (2)
Interest for this study
The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life.
Measured: baseline, 1 month, & 4 month
Interest for this study
The secondary outcome measures of interest for this study is an interview to evaluate the intervention will be conducted with the participant and the partner at the conclusion of the study.
Measured: baseline, 1 month, & 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non Small Cell LungStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Massachusetts, Boston
- Responsible party
- Principal investigator, Mary E. Cooley, Phd, Dana-Farber Cancer Institute
- Investigators
- Mary E. Cooley, PhD, RN, FAAN, Principal investigator, Dana Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135211
- Sponsor's protocol ID
- 12-150
- Status last verified
- Jun 2018
- First submitted
- 6 May 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
- ClinicalTrials.gov ID
- NCT02135211
- Acronym / sponsor ID
- 12-150
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- non-small cell lung cancer (NSCLC), multiple risk factor, lifestyle intervention, health behavior, lifestyle risk reduction, health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Massachusetts, Boston
- Study start
- Sep 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 May 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.
The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingThis is a single arm, quasi-experimental, pre- and post- test study design to test the feasibility and acceptability of a multiple risk factor, lifestyle intervention in patients receiving surgical treatment for lung cancer or those suspected of having lung cancer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lifestyle counseling | Behavioural | Lifestyle counseling |
Primary outcome
Feasibility and acceptability
Time frame: at end of study (4 months post intervention)
The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.
Feasibility and acceptability
Time frame: at end of study (4 months post intervention)
The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials
Feasibility and acceptability
Time frame: at end of study (4 months post intervention
The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring
Feasibility and acceptability
Time frame: at end of study (4 months post intervention)
The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.
2 secondary outcomes
Interest for this study
Time frame: baseline, 1 month, & 4 month
Interest for this study
Time frame: baseline, 1 month, & 4 month
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 2 Jul 2018.
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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.
Mary E. Cooley, PhD, RN, FAAN principal investigator
Dana Farber Cancer Insitute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Carcinoma, Non Small Cell Lung, run by Dana-Farber Cancer Institute 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?
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 2 Jul 2018. 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?
Feasibility and acceptability (time frame: at end of study (4 months post intervention)). 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 2 Jul 2018.