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

Mass General Brigham

Status: Unknown

Conditions: Small-cell Lung Cancer; Cognitive Behavioral Therapy; Mesothelioma; Non Small Cell Lung Cancer

Treatments: Behavioral: RCT Transitions Program Sessions 1-5; Behavioral: RCT Control Session; Behavioral: Run-In Sessions 1-5

Study type: Interventional

Funder types: Other

Identifiers

NCT04450043

20-140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Run In

Experimental group

Description:

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.

Treatment:

Behavioral: Run-In Sessions 1-5

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: RCT Transitions Program Sessions 1-5

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: RCT Control Session