An interventional study of Five Psycho-educational Session(s) and One Psycho-educational Session(s) in Lung Cancer, sponsored by Massachusetts General Hospital. Active, not recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Completed cancer treatment within past 3 weeks
Exclusion Criteria:
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.
Behavioral: Five 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.
Behavioral: One Psycho-educational Session(s)
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
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
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)
Time frame: Up to 12 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 12 weeks
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital