The Transitions Project: Efficacy Trial

Mass General Brigham

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: One Psycho-educational Session(s); Behavioral: Five Psycho-educational Session(s)

Study type: Interventional

Funder types: Other

Identifiers

NCT05087251

21-426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention: Five Psycho-educational Sessions

Experimental group

Description:

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.

Treatment:

Behavioral: Five Psycho-educational Session(s)

Enhanced Usual Care: One Psycho-educational Session

Experimental group

Description:

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.

Treatment:

Behavioral: One Psycho-educational Session(s)