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The Transitions Project: Efficacy Trial

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Five Psycho-educational Session(s)
One Psycho-educational Session(s)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung Cancer, Supportive Care

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention: Five Psycho-educational Sessions

Enhanced Usual Care: One Psycho-educational Session

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
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

Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
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
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
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
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
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)

Full Information

First Posted
October 1, 2021
Last Updated
November 9, 2022
Sponsor
Massachusetts General Hospital
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT05087251
Brief Title
The Transitions Project: Efficacy Trial
Official Title
Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Lung Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Supportive Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Five Psycho-educational Sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care: One Psycho-educational Session
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Five Psycho-educational Session(s)
Intervention Description
5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty
Intervention Type
Behavioral
Intervention Name(s)
One Psycho-educational Session(s)
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
Description
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)
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7
Description
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)
Time Frame
Up to 12 weeks
Title
Symptom burden: Edmonton Symptom Assessment Scale
Description
We will investigate longitudinal differences in symptom burden (Edmonton Symptom Assessment Scale score range 0-90, with higher scores indicating more symptom burden)
Time Frame
Up to 12 weeks
Title
Psychological symptom burden: Hospital Anxiety and Depression Scale
Description
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)
Time Frame
Up to 12 weeks
Title
Social support: Multidimensional Scale of Perceived Social Support
Description
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)
Time Frame
Up to 12 weeks
Title
Social isolaton: Campaign to End Loneliness Measurement Tool
Description
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)
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Traeger, PhD
Phone
(617) 643-4314
Email
LTRAEGER@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Traeger, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Traeger, PhD
Phone
617-643-4314
Email
LTRAEGER@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Lara Traeger, PhD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Bober, PhD
Phone
617-632-6547
Email
Sharon_Bober@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Timothy Sannes, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

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The Transitions Project: Efficacy Trial

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