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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
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.
Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Number of participants enrolled
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Time frame: 12 Weeks
Number of participants retained
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Time frame: 12 Weeks
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)
Time frame: 12 weeks
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)
Time frame: Week 12
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.
Time frame: pre-baseline to 12 weeks
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.
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Time frame: pre-baseline to 12 weeks
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.
Time frame: pre-baseline to 12 weeks
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.
Time frame: pre-baseline to 12 Weeks