The Transitions Project: Efficacy Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Five Psycho-educational Session(s); Behavioral: One Psycho-educational Session(s)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Comorbid health condition that would interfere with study participation
• Current participation in cognitive behavioral therapy treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Five Psycho-educational Sessions; 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); 5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
Experimental: Enhanced Usual Care: One Psycho-educational Session; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Lung Association
• Investigators: Principal Investigator: Lara Traeger, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): June 15, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Supportive Care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21-426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No