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Transitions Project

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ClinicalTrials.gov Identifier: NCT04450043
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital

Brief Summary:
This research study is designed to develop and test a new supportive care program to help individuals with lung cancer improve their quality of life after cancer treatment is over.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Small-cell Lung Cancer Mesothelioma Cognitive Behavioral Therapy Behavioral: Study Session 1-5 Not Applicable

Detailed Description:

The aims of this pilot study are to evaluate the feasibility and acceptability of a brief psychoeducational intervention for participants with cancer who are transitioning from active treatment to surveillance.

The research study procedures include screening for eligibility.

This study consists of 2 parts. It is expected that about 45 people will take part in this research study.

  • In the first part of this study, about 5 participants will complete survey questions and receive a 5-session program.
  • In the second part of this study, about 40 participants will complete survey questions and the first session, and then will be randomly assigned to receive the rest of the sessions or to not receive the rest of the sessions.
  • These sessions will focus on providing targeted support related to life after cancer treatment. The sessions will focus on skills for coping with uncertainty, managing symptoms, improving social support, and other topics important to the individual.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : November 1, 2023


Arm Intervention/treatment
Experimental: Run In

Recruit up to 5 patients who meet eligibility criteria to participate in the run-in period of the study.

  • Participants will receive Sessions 1-5 of the psychoeducational intervention condition and will complete both assessments and a semistructured interview about the intervention.
  • Session 1 with a study interventionist, focused on identifying participant's goals, expectations and wishes for post-treatment quality of life, as well as a handout listing local and national support resources.
  • Session 2-5 is focused on teaching skills to enhance post-treatment quality of life, with attention to (a) managing expectations about life after cancer treatment, (b) managing uncertainty (e.g., fears of cancer recurrence), (c) enhancing self-management of residual symptoms and (d) strengthening social support
Behavioral: Study Session 1-5

Session 1 with a study interventionist, focused on identifying participant's goals, expectations and wishes for post-treatment quality of life, as well as a handout listing local and national support resources.

Session 2-5 is focused on teaching skills to enhance post-treatment quality of life, with attention to (a) managing expectations about life after cancer treatment, (b) managing uncertainty (e.g., fears of cancer recurrence), (c) enhancing self-management of residual symptoms and (d) strengthening social support


Experimental: Intervention=Study Sessions

Participants randomized to this arm will receive Sessions 1-5

  • Session 1 with a study interventionist, focused on identifying participant's goals, expectations and wishes for post-treatment quality of life, as well as a handout listing local and national support resources.
  • Session 2-5 is focused on teaching skills to enhance post-treatment quality of life, with attention to (a) managing expectations about life after cancer treatment, (b) managing uncertainty (e.g., fears of cancer recurrence), (c) enhancing self-management of residual symptoms and (d) strengthening social support
Behavioral: Study Session 1-5

Session 1 with a study interventionist, focused on identifying participant's goals, expectations and wishes for post-treatment quality of life, as well as a handout listing local and national support resources.

Session 2-5 is focused on teaching skills to enhance post-treatment quality of life, with attention to (a) managing expectations about life after cancer treatment, (b) managing uncertainty (e.g., fears of cancer recurrence), (c) enhancing self-management of residual symptoms and (d) strengthening social support


No Intervention: Control=Session 1 and No Additional Study Sessions
Participants randomized to this arm will receive Session 1 with a study interventionist, focused on identifying participant's goals, expectations and wishes for post-treatment quality of life, as well as a handout listing local and national support resources.



Primary Outcome Measures :
  1. Number of participants enrolled [ Time Frame: 14 Weeks ]
    Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)

  2. Number of participants retained [ Time Frame: 14 Weeks ]
    Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)

  3. Proportion of intervention arm participants who complete study visits [ Time Frame: 14 weeks ]
    Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)


Secondary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score [ Time Frame: baseline to 14 weeks ]
    This measure assesses multidimensional quality of life including physical well-being, social/family well-being, emotional well-being, functional well-being, and lung cancer-specific concerns. Each item is answered on a scale of 0 (not at all) to 5 (very much). Total scores will be used, with higher scores indicating better quality of life.

  2. Change in Fear of Cancer Recurrence Scale 7 score [ Time Frame: baseline to 14 weeks ]
    This measure assesses worry about the return of disease with 6 items measured on a 5-point scale and 1 item measured on a 10-point scale. Total scores will be used, with higher scores indicating greater fear of recurrence.

  3. Change in Hospital Anxiety and Depression Scale score [ Time Frame: baseline to 14 weeks ]
    This measure assesses depression and anxiety symptoms (7 items each), and mixed affect (all 14 items). Total scores will be used, with higher scores indicating greater distress.

  4. Change in Multidimensional Scale of Perceived Social Support score [ Time Frame: baseline to 14 Weeks ]
    This measure assesses social support using 12 items on a 7-point Likert-type scale. Mean scores will be used, with higher scores indicating greater perceived support.

  5. Acceptability of study [ Time Frame: Week 14 ]
    Participant concerns and recommendations will be used to guide the next trial with respect to intervention content and delivery. Participant responses to the exit interview will be summarized (descriptive statistics for quantitative items) and coded (content analysis for open-ended items)



Information from the National Library of Medicine

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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
  • Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma
  • Documented treatment plan with curative intent
  • Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital
  • Ability to read and respond in English

Exclusion Criteria:

  • Comorbid health condition that would interfere with study participation
  • Current participation in cognitive behavioral therapy treatment

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): NCT04450043


Contacts
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Contact: Lara Traeger, Ph.D (617) 643-4314 ltraeger@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lara Traeger, Ph.D    617-643-4314    ltraeger@partners.org   
Principal Investigator: Lara Traeger, Ph.D         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Lara Traeger, Ph.D Massachusetts General Hospital
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Responsible Party: Lara Traeger, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04450043    
Other Study ID Numbers: 20-140
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
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 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:
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Mesothelioma
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Mesothelioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial