Clinical trial NCT04450043: The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Official title: The Transitions Project: Supporting Adults During the Shift From Cancer Treatment to Surveillance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Small-cell Lung Cancer
Mesothelioma
Cognitive Behavioral Therapy
Keywords: Non Small Cell Lung Cancer
Small-cell Lung Cancer
Mesothelioma
Cognitive Behavioral Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Number of participants enrolled
timeFrame: 12 Weeks
measure: Number of participants retained
timeFrame: 12 Weeks
measure: Proportion of intervention arm participants who complete study visits
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of study
timeFrame: Week 12
measure: Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score
timeFrame: pre-baseline to 12 weeks
measure: Change in Fear of Cancer Recurrence Scale 7 score
timeFrame: pre-baseline to 12 weeks
measure: Change in Hospital Anxiety and Depression Scale score
timeFrame: pre-baseline to 12 weeks
measure: Change in Multidimensional Scale of Perceived Social Support score
timeFrame: pre-baseline to 12 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lara Traeger, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: