The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Proportion of intervention arm participants who complete study visits
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Lara Traeger
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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.
- •If final treatment is systemic therapy +/- radiation: within three weeks after cancer care team determination that treatment is complete.
- •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
Outcomes
Primary Outcomes
Proportion of intervention arm participants who complete study visits
Time Frame: 12 weeks
Feasibility will be assessed by calculating the proportion of intervention arm participants who complete study visits (≥70% attending ≥60% of sessions)
Number of participants retained
Time Frame: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)
Number of participants enrolled
Time Frame: 12 Weeks
Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)
Secondary Outcomes
- Change in Hospital Anxiety and Depression Scale score(pre-baseline to 12 weeks)
- Change in Multidimensional Scale of Perceived Social Support score(pre-baseline to 12 Weeks)
- Acceptability of study(Week 12)
- Change in Fear of Cancer Recurrence Scale 7 score(pre-baseline to 12 weeks)
- Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score(pre-baseline to 12 weeks)