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|ClinicalTrials.gov Identifier: NCT04450043|
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : September 3, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|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|
Experimental: Run In
Recruit up to 5 patients who meet eligibility criteria to participate in the run-in period of the study.
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
Behavioral: Study Session 1-5
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.
- Number of participants enrolled [ Time Frame: 14 Weeks ]Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
- Number of participants retained [ Time Frame: 14 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: 14 weeks ]Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
- 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.
- 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.
- 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.
- 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.
- 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)
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
|Contact: Lara Traeger, Ph.D||(617) email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Lara Traeger, Ph.D 617-643-4314 firstname.lastname@example.org|
|Principal Investigator: Lara Traeger, Ph.D|
|Principal Investigator:||Lara Traeger, Ph.D||Massachusetts General Hospital|