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NCT Number: NCT04450043

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Small Cell Lung Cancer Adenoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cognitive Behavioral Therapy Lung Diseases Lung Neoplasms Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Small-cell Lung Cancer Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Run-In Sessions 1-5

Behavioral

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

Behavioral

Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.

RCT Control Session

Behavioral

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.

Primary outcomes

  1. Number of participants enrolled

    Time frame: 12 Weeks

    Feasibility will be assessed by calculating the proportions of potential participants enrolled (≥35%)

  2. Number of participants retained

    Time frame: 12 Weeks

    Feasibility will be assessed by calculating the proportions of potential participants retained (≥70%)

  3. 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)

Secondary outcomes

  1. Acceptability of study

    Time frame: Week 12

    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)

  2. Change in Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score

    Time frame: pre-baseline to 12 weeks

    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.

  3. Change in Fear of Cancer Recurrence Scale 7 score

    Time frame: pre-baseline to 12 weeks

    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.

  4. Change in Hospital Anxiety and Depression Scale score

    Time frame: pre-baseline to 12 weeks

    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.

  5. Change in Multidimensional Scale of Perceived Social Support score

    Time frame: pre-baseline to 12 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2026
First posted
Jun 29, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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