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The Transitions Project: Efficacy Trial

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ClinicalTrials.gov Identifier: NCT05087251
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital

Study Description
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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) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 30, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087251


Contacts
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Contact: Lara Traeger, PhD (617) 643-4314 LTRAEGER@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lara Traeger, PhD    617-643-4314    LTRAEGER@mgh.harvard.edu   
Principal Investigator: Lara Traeger, PhD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sharon Bober, PhD    617-632-6547    Sharon_Bober@DFCI.HARVARD.EDU   
Principal Investigator: Timothy Sannes, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
American Lung Association
Investigators
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Principal Investigator: Lara Traeger, PhD Massachusetts General Hospital
More Information
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Responsible Party: Lara Traeger, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05087251    
Other Study ID Numbers: 21-426
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Traeger, Massachusetts General Hospital:
Lung Cancer
Supportive Care
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases