Lung CancerNCT05087251
The Transitions Project: Efficacy Trial
A study testing Five Psycho-educational Session(s) and One Psycho-educational Session(s) in people with Lung Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Five Psycho-educational Session(s) and One Psycho-educational Session(s)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2021to 30 Jun 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
- Able to read and respond in English
- Diagnosis of non-small cell lung cancer or small cell lung cancer
- Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
- Completed cancer treatment within past 3 weeks
- If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete
- If final treatment is surgery: within 3 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
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.
Read the detailed description
This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance.
In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program.
It is expected that about 100 people will take part in this research study.
The American Lung Association is supporting this research by providing funding for the research study.
- Conditions
- Lung Cancer
- Being tested
- Five Psycho-educational Session(s), One Psycho-educational Session(s)
- Keywords
- Lung Cancer, Supportive Care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five Psycho-educational Session(s)Behavioural
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
One Psycho-educational Session(s)Behavioural
1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Five Psycho-educational Sessions | Experimental | Approximately 6 weeks after the patient's cancer treatment is complete, participants in the intervention arm will proceed to receive up to 5 study sessions (approximately weekly, ~50 minutes each) with a trained interventionist focused on psychoeducational topics. This arm was designed to enhance patient skills to address key concerns during the transition from treatment to surveillance, using a cognitive-behavioral approach. Sessions will be based on an intervention manual. Receives: Behavioral: Five Psycho-educational Session(s) |
| Enhanced Usual Care: One Psycho-educational Session | Experimental | At approximately 6 weeks after treatment completion (as defined by our eligibility criteria), control patients will attend one study session (~50 minutes) with a study clinician. This session is designed to control for patient access and connection to psychosocial resources as recommended in recent work. Receives: Behavioral: One Psycho-educational Session(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)
Measured: Up to 12 weeks
Secondary outcomes (5)
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
We will investigate longitudinal differences in fear of cancer recurrence between study groups (Fear of Cancer Recurrence Scale 7, score range 7-35, with higher scores indicating more fear of cancer recurrence)
Measured: Up to 12 weeks
Symptom burden: Edmonton Symptom Assessment Scale
We will investigate longitudinal differences in symptom burden (Edmonton Symptom Assessment Scale score range 0-90, with higher scores indicating more symptom burden)
Measured: Up to 12 weeks
Psychological symptom burden: Hospital Anxiety and Depression Scale
We will investigate longitudinal differences in psychological symptom burden (Hospital Anxiety and Depression Scale score range 0-42 with higher scores indicating more psychological symptom burden)
Measured: Up to 12 weeks
Social support: Multidimensional Scale of Perceived Social Support
We will investigate longitudinal differencs in social support (Multidimensional Scale of Perceived Social Support score range 12-84, with higher scores indicating more social support)
Measured: Up to 12 weeks
Social isolaton: Campaign to End Loneliness Measurement Tool
We will investigate longitudinal differences in social isolation (Campaign to End Loneliness measurement tool score range 0-12 with higher scores indicating more social isolation)
Measured: Up 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 posted21 Oct 2021
- Study start30 Sep 2021
- Primary completion15 Jun 2024
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Principal investigator, Lara Traeger, Massachusetts General Hospital
- Investigators
- Lara Traeger, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087251
- Sponsor's protocol ID
- 21-426
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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: \[contact information for Sponsor Investigator or designee\]. 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
- ClinicalTrials.gov ID
- NCT05087251
- Acronym / sponsor ID
- 21-426
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Supportive Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Oct 2021 (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.
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.
Detailed description
This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance.
In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program.
It is expected that about 100 people will take part in this research study.
The American Lung Association is supporting this research by providing funding for the research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Five Psycho-educational Sessions | Experimental | Behavioral: Five Psycho-educational Session(s)Approximately 6 weeks after the patient's cancer treatment is complete, participants in the intervention arm will proceed to receive up to 5 study sessions (approximately weekly, ~50 minutes each) with a trained interventionist focused on psychoeducational topics. This arm was designed to enhance patient skills to address key concerns during the transition from treatment to surveillance, using a cognitive-behavioral approach. Sessions will be based on an intervention manual. |
| Enhanced Usual Care: One Psycho-educational Session | Experimental | Behavioral: One Psycho-educational Session(s)At approximately 6 weeks after treatment completion (as defined by our eligibility criteria), control patients will attend one study session (~50 minutes) with a study clinician. This session is designed to control for patient access and connection to psychosocial resources as recommended in recent work. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21 or older
- Able to read and respond in English
- Diagnosis of non-small cell lung cancer or small cell lung cancer
- Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
- Completed cancer treatment within past 3 weeks
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 |
|---|---|---|
| Five Psycho-educational Session(s)5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty | Behavioural | Intervention: Five Psycho-educational Sessions |
| One Psycho-educational Session(s)1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations | Behavioural | Enhanced Usual Care: One Psycho-educational Session |
Primary outcome
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
Time frame: Up to 12 weeks
We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)
5 secondary outcomes
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
Time frame: Up to 12 weeks
Symptom burden: Edmonton Symptom Assessment Scale
Time frame: Up to 12 weeks
Psychological symptom burden: Hospital Anxiety and Depression Scale
Time frame: Up to 12 weeks
Social support: Multidimensional Scale of Perceived Social Support
Time frame: Up to 12 weeks
Social isolaton: Campaign to End Loneliness Measurement Tool
Time frame: Up 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 30 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: [contact information for 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, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five Psycho-educational Session(s) and One Psycho-educational Session(s) in people with Lung Cancer, run by Massachusetts General Hospital 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 7 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 30 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 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?
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?
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer (time frame: Up to 12 weeks). 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 30 Mar 2026.