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The Transitions Project: Efficacy Trial
Boston, MA
N/A
Waitlist Available
Led By Lara Traeger, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether a short educational intervention can improve quality of life for lung cancer patients who are done with active treatment and are just being monitored.
See full description
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
Secondary study objectives
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
Psychological symptom burden: Hospital Anxiety and Depression Scale
Social isolaton: Campaign to End Loneliness Measurement Tool
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention: Five Psycho-educational SessionsExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual Care: One Psycho-educational SessionExperimental Treatment1 Intervention
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.
Find a Location
Closest Location:Dana-Farber Cancer Institute· Boston, MA· 879 miles
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,057 Previous Clinical Trials
13,425,491 Total Patients Enrolled
American Lung AssociationOTHER
31 Previous Clinical Trials
10,853 Total Patients Enrolled
Lara Traeger, PhDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
343 Total Patients Enrolled