The Transitions Project: Efficacy Trial

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Five Psycho-educational Session(s); Behavioral: One Psycho-educational Session(s)

• Registration Number: NCT05087251
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

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 Timeline

• Study Start: 2021-09-30
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Five Psycho-educational Sessions	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	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.

Primary Outcome Measures

Name	Time	Method
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer	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)

Secondary Outcome Measures

Name	Time	Method
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7	Up to 12 weeks	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)
Symptom burden: Edmonton Symptom Assessment Scale	Up to 12 weeks	We will investigate longitudinal differences in symptom burden (Edmonton Symptom Assessment Scale score range 0-90, with higher scores indicating more symptom burden)
Psychological symptom burden: Hospital Anxiety and Depression Scale	Up to 12 weeks	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)
Social support: Multidimensional Scale of Perceived Social Support	Up to 12 weeks	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)
Social isolaton: Campaign to End Loneliness Measurement Tool	Up to 12 weeks	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)

Trial Locations

Locations (2)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States