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The Transitions Project: Efficacy Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 1, 2021
First Posted Date  ICMJE October 21, 2021
Last Update Posted Date November 14, 2022
Actual Study Start Date  ICMJE September 30, 2021
Estimated Primary Completion Date March 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2021)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2021)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Transitions Project: Efficacy Trial
Official Title  ICMJE Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Behavioral: Five Psycho-educational Session(s)
    5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Five Psycho-educational Session(s)
  • 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.
    Intervention: Behavioral: One Psycho-educational Session(s)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2021)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date March 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lara Traeger, PhD (617) 643-4314 LTRAEGER@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05087251
Other Study ID Numbers  ICMJE 21-426
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Current Responsible Party Lara Traeger, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE American Lung Association
Investigators  ICMJE
Principal Investigator: Lara Traeger, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP