The Transitions Project: Efficacy Trial

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05087251
• Other study ID #: 21-426
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: Lara Traeger, PhD
• Phone: (617) 643-4314
• Email: LTRAEGER[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Five Psycho-educational Session(s)
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
• 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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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