The Transitions Project: Efficacy Trial

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05087251
• Collaborator: American Lung Association (Other)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 50
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Behavioral: Five Psycho-educational Session(s); Behavioral: One Psycho-educational Session(s)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
• Actual Study Start Date: Sep 30, 2021
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: Five Psycho-educational Sessions 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.	Behavioral: Five Psycho-educational Session(s); 5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
Experimental: Enhanced Usual Care: One Psycho-educational Session 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.	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Massachusetts General Hospital
• American Lung Association

Investigators

• Principal Investigator: Lara Traeger, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lara Traeger, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05087251
• Other Study ID Numbers: 21-426
• First Posted: Oct 21, 2021
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lara Traeger, Principal Investigator, Massachusetts General Hospital: Lung Cancer; Supportive Care
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Jan 13, 2022