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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05087251
Other study ID # 21-426
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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