Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04450043
Other study ID # 20-140
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Completed NCT03780010 - Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC Phase 1