Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Small Cell Lung Carcinoma

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Small Cell Lung Cancer

Malignant Mesothelioma

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.

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.

Run-In Sessions 1-5

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

RCT Transitions Program Sessions 1-5

RCT Control Session

Lara Traeger, Ph.D

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.

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.

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

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.

Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)

Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)

Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)

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)

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance	NCT04450043	Non Small Cell ... Small-cell Lung... Mesothelioma Cognitive Behav...	Run-In Sessions... RCT Transitions... RCT Control Ses...	21 Years -	Massachusetts General Hospital
The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance	NCT04450043	Non Small Cell ... Small-cell Lung... Mesothelioma Cognitive Behav...	Run-In Sessions... RCT Transitions... RCT Control Ses...	21 Years -	Massachusetts General Hospital

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