The Transitions Project: Efficacy Trial

NCT ID: NCT05087251

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Five Psycho-educational Session(s)

Intervention Type BEHAVIORAL

5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty

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.

Group Type EXPERIMENTAL

One Psycho-educational Session(s)

Intervention Type BEHAVIORAL

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

Interventions

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Five Psycho-educational Session(s)

5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Lung Association

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lara Traeger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara Traeger, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lara Traeger, PhD

Role: CONTACT

(617) 643-4314

Facility Contacts

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Lara Traeger, PhD

Role: primary

617-643-4314

Sharon Bober, PhD

Role: primary

617-632-6547

Other Identifiers

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21-426

Identifier Type: -

Identifier Source: org_study_id

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