Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05087251

The Transitions Project: Efficacy Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Five Psycho-educational Session(s)

Behavioral

5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty

One Psycho-educational Session(s)

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7

    Time frame: 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)

  2. Symptom burden: Edmonton Symptom Assessment Scale

    Time frame: 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)

  3. Psychological symptom burden: Hospital Anxiety and Depression Scale

    Time frame: 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)

  4. Social support: Multidimensional Scale of Perceived Social Support

    Time frame: 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)

  5. Social isolaton: Campaign to End Loneliness Measurement Tool

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Lung Association

Registry information

Official study title

Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.