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The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance

Primary Purpose

Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Run-In Sessions 1-5
RCT Transitions Program Sessions 1-5
RCT Control Session
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy

Eligibility Criteria

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

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
  • Ability to read and respond in English
  • Treatment completion eligibility:

Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital.

RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery.

  1. If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
  2. If final treatment is surgery: within three 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Run In

Intervention

Control

Arm Description

Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.

Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.

Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.

Outcomes

Primary Outcome Measures

Number of participants enrolled
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Number of participants retained
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Proportion of intervention arm participants who complete study visits
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)

Secondary Outcome Measures

Acceptability of study
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)
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
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.
Change in Fear of Cancer Recurrence Scale 7 score
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.
Change in Hospital Anxiety and Depression Scale score
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.
Change in Multidimensional Scale of Perceived Social Support score
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.

Full Information

First Posted
June 24, 2020
Last Updated
January 11, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04450043
Brief Title
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Official Title
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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

5. Study Description

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.
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 3 surveys, and then will be randomly assigned to receive the 5-session program or to receive one study session (control). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy
Keywords
Non Small Cell Lung Cancer, Small-cell Lung Cancer, Mesothelioma, Cognitive Behavioral Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Run In
Arm Type
Experimental
Arm Description
Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive a 5-session psychoeducational intervention, focused on skills to enhance post-treatment quality of life with attention to (a) managing expectations, (b) coping with uncertainty, (c) self-managing residual symptoms and (d) strengthening social support.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
Intervention Type
Behavioral
Intervention Name(s)
Run-In Sessions 1-5
Intervention Description
Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
Intervention Type
Behavioral
Intervention Name(s)
RCT Transitions Program Sessions 1-5
Intervention Description
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
Intervention Type
Behavioral
Intervention Name(s)
RCT Control Session
Intervention Description
Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
Primary Outcome Measure Information:
Title
Number of participants enrolled
Description
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Time Frame
12 Weeks
Title
Number of participants retained
Description
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Time Frame
12 Weeks
Title
Proportion of intervention arm participants who complete study visits
Description
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Acceptability of study
Description
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)
Time Frame
Week 12
Title
Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
Description
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.
Time Frame
pre-baseline to 12 weeks
Title
Change in Fear of Cancer Recurrence Scale 7 score
Description
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.
Time Frame
pre-baseline to 12 weeks
Title
Change in Hospital Anxiety and Depression Scale score
Description
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.
Time Frame
pre-baseline to 12 weeks
Title
Change in Multidimensional Scale of Perceived Social Support score
Description
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.
Time Frame
pre-baseline 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 Diagnosis of non-small cell (NSCLC) or small cell (SCLC) lung cancer or mesothelioma Documented treatment plan with curative intent Ability to read and respond in English Treatment completion eligibility: Run-in: Has completed treatment including systemic treatments and radiation as determined within the past three weeks by the cancer care team at Massachusetts General Hospital. RCT: Has completed treatment including systemic treatments +/- radiation and +/- surgery. If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete. If final treatment is surgery: within three weeks after hospital discharge following surgery. Exclusion Criteria: Comorbid health condition that would interfere with study participation Current participation in cognitive behavioral therapy treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Traeger, Ph.D
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

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 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

Learn more about this trial

The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance

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