Non Small Cell Lung CancerNCT04450043
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
A study testing Run-In Sessions 1-5 and RCT Transitions Program Sessions 1-5 in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma
- What is being tested?
- Run-In Sessions 1-5 and RCT Transitions Program Sessions 1-5
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 21 or older
- Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
- Documented treatment plan with curative intent
- Ability to read and respond in English
- Treatment completion eligibility:
- Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.
Show all 9Show fewer
- RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.
- If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
- If final treatment is surgery: within three weeks after hospital discharge following surgery.
Who cannot join
- Comorbid health condition that would interfere with study participation
- Current participation in cognitive behavioral therapy treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.
Read the detailed description
The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.
The research study procedures include screening for eligibility.
This study consists of 2 parts. It is expected that about 45 people will take part in this research study.
- In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
- In the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control).
- These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
- Being tested
- Run-In Sessions 1-5, RCT Transitions Program Sessions 1-5, RCT Control Session
- Keywords
- Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Run-In Sessions 1-5Behavioural
Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
RCT Transitions Program Sessions 1-5Behavioural
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
RCT Control SessionBehavioural
Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
| Study group | Role | What they receive |
|---|---|---|
| Run In | Experimental | Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support. Receives: Behavioral: Run-In Sessions 1-5 |
| Intervention | Experimental | Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support. Receives: Behavioral: RCT Transitions Program Sessions 1-5 |
| Control | Active comparator | Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources. Receives: Behavioral: RCT Control Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Measured: 12 Weeks
Number of participants retained
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Measured: 12 Weeks
Proportion of intervention arm participants who complete study visits
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
Measured: 12 weeks
Secondary outcomes (5)
Acceptability of study
Participant concerns and recommendations will be used to guide the next trial with respect to intervention content and delivery. Participant responses to the exit interview will be summarized (descriptive statistics for quantitative items) and coded (content analysis for open-ended items)
Measured: Week 12
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
This measure assesses multidimensional quality of life including physical well-being, social/family well-being, emotional well-being, functional well-being, and lung cancer-specific concerns. Each item is answered on a scale of 0 (not at all) to 5 (very much). Total scores will be used, with higher scores indicating better quality of life.
Measured: pre-baseline to 12 weeks
Change in Fear of Cancer Recurrence Scale 7 score
This measure assesses worry about the return of disease with 6 items measured on a 5-point scale and 1 item measured on a 10-point scale. Total scores will be used, with higher scores indicating greater fear of recurrence.
Measured: pre-baseline to 12 weeks
Change in Hospital Anxiety and Depression Scale score
This measure assesses depression and anxiety symptoms (7 items each), and mixed affect (all 14 items). Total scores will be used, with higher scores indicating greater distress.
Measured: pre-baseline to 12 weeks
Change in Multidimensional Scale of Perceived Social Support score
This measure assesses social support using 12 items on a 7-point Likert-type scale. Mean scores will be used, with higher scores indicating greater perceived support.
Measured: pre-baseline to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Aug 2020
- Primary completion4 Jan 2022
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Traeger, Massachusetts General Hospital
- Investigators
- Lara Traeger, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450043
- Sponsor's protocol ID
- 20-140
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
- ClinicalTrials.gov ID
- NCT04450043
- Acronym / sponsor ID
- 20-140
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
- Keywords
- Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Jun 2020 (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 research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.
Detailed description
The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.
The research study procedures include screening for eligibility.
This study consists of 2 parts. It is expected that about 45 people will take part in this research study.
- In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
- In the second part of this study, about 40 participants will complete 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control).
- These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Run In | Experimental | Behavioral: Run-In Sessions 1-5Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support. |
| Intervention | Experimental | Behavioral: RCT Transitions Program Sessions 1-5Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support. |
| Control | Active comparator | Behavioral: RCT Control SessionParticipants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21 or older
- Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
- Documented treatment plan with curative intent
- Ability to read and respond in English
- Treatment completion eligibility:
Key exclusion criteria (2 listed)
- Comorbid health condition that would interfere with study participation
- Current participation in cognitive behavioral therapy treatment
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 |
|---|---|---|
| Run-In Sessions 1-5Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life. | Behavioural | Run In |
| RCT Transitions Program Sessions 1-5Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life. | Behavioural | Intervention |
| RCT Control SessionParticipants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources. | Behavioural | Control |
Primary outcome
Number of participants enrolled
Time frame: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Number of participants retained
Time frame: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Proportion of intervention arm participants who complete study visits
Time frame: 12 weeks
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
5 secondary outcomes
Acceptability of study
Time frame: Week 12
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
Time frame: pre-baseline to 12 weeks
Change in Fear of Cancer Recurrence Scale 7 score
Time frame: pre-baseline to 12 weeks
Change in Hospital Anxiety and Depression Scale score
Time frame: pre-baseline to 12 weeks
Change in Multidimensional Scale of Perceived Social Support score
Time frame: pre-baseline to 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Lara Traeger, Ph.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Run-In Sessions 1-5 and RCT Transitions Program Sessions 1-5 in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Massachusetts General Hospital 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 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants enrolled (time frame: 12 Weeks). The study lists 3 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 27 Mar 2026.