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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04450043
• Other study ID #: 20-140
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: November 1, 2023
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cognitive Behavioral Therapy
• Lung Neoplasms
• Mesothelioma
• Mesothelioma, Malignant
• Non Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

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.
• RCT Transitions Program Sessions 1-5
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled	Feasibility will be assessed by calculating the proportions of potential participants enrolled (=35%)	12 Weeks
Primary	Number of participants retained	Feasibility will be assessed by calculating the proportions of potential participants retained (=70%)	12 Weeks
Primary	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)	12 weeks
Secondary	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)	Week 12
Secondary	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.	pre-baseline to 12 weeks
Secondary	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.	pre-baseline to 12 weeks
Secondary	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.	pre-baseline to 12 weeks
Secondary	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.	pre-baseline to 12 Weeks