The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
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ClinicalTrials.gov Identifier: NCT04450043 |
Recruitment Status :
Active, not recruiting
First Posted : June 29, 2020
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Non Small Cell Lung Cancer Small-cell Lung Cancer Mesothelioma Cognitive Behavioral Therapy | Behavioral: Run-In Sessions 1-5 Behavioral: RCT Transitions Program Sessions 1-5 Behavioral: RCT Control Session | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 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 |
Actual Primary Completion Date : | January 4, 2022 |
Estimated Study Completion Date : | November 1, 2023 |

Arm | Intervention/treatment |
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Experimental: Run In
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.
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Behavioral: Run-In Sessions 1-5
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. |
Experimental: Intervention
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.
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Behavioral: RCT Transitions Program Sessions 1-5
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life. |
Active Comparator: Control
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.
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Behavioral: RCT Control Session
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. |
- Number of participants enrolled [ Time Frame: 12 Weeks ]Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
- Number of participants retained [ Time Frame: 12 Weeks ]Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
- Proportion of intervention arm participants who complete study visits [ Time Frame: 12 weeks ]Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
- Acceptability of study [ Time Frame: Week 12 ]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 [ Time Frame: pre-baseline to 12 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.
- Change in Fear of Cancer Recurrence Scale 7 score [ Time Frame: pre-baseline to 12 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.
- Change in Hospital Anxiety and Depression Scale score [ Time Frame: pre-baseline to 12 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.
- Change in Multidimensional Scale of Perceived Social Support score [ Time Frame: pre-baseline to 12 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lara Traeger, Ph.D | Massachusetts General Hospital |
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: | January 13, 2022 |
Last Verified: | January 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 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Non Small Cell Lung Cancer Small-cell Lung Cancer Mesothelioma Cognitive Behavioral Therapy |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma Mesothelioma Mesothelioma, Malignant 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 Pleural Neoplasms |