Lung Cancer
Conditions
Keywords
Lung Cancer, Supportive Care
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.
Interventions
BEHAVIORALFive Psycho-educational Session(s)
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
BEHAVIORALOne 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
Sponsors
Massachusetts General Hospital
American Lung Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLara Traeger, PhD
Massachusetts General Hospital
Outcome results
None listed