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Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will complete baseline survey measures and be randomized to intervention."
  • "Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Pathways, a brief support program, for adults getting treatment for advanced lung cancer. It compares Pathways with enhanced usual care to see how they affect mental health and quality of life.

This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • New or returned non-small cell lung cancer at stage 3b, 3c, or 4, or extensive-stage small cell lung cancer (cancer that has spread widely).
  • Able to do at least some daily activities, with an ECOG score of 0–2 or Karnofsky score of 60–100. These scores measure how well you can carry out daily tasks.
  • Between 3 and 12 weeks into cancer treatment given by infusion, such as chemotherapy, immunotherapy, or both.
  • A distress score of at least 3 out of 10 in your health record for the past month, or at least 2 on a Rotterdam survey question about emotional distress.

Who can't join

  • Cancer that has spread to the brain and is not stable, such as worsening nerve or brain problems, poorly controlled seizures, or a need for higher steroid doses.
  • A thinking or mental health condition, such as dementia or a psychotic disorder, that makes taking part unsuitable.
  • Getting overlapping palliative care (care to ease symptoms) or mental health services at the cancer center.
  • Unable to speak and read English.
  • Hearing or vision problems that prevent taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer * 18 years of age or older * Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100 * 3-12 weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy) * Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items. Exclusion Criteria: * Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses) * Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate * Receiving overlapping palliative care or psychological services at the cancer center * Unable to speak and read English. * Hearing or visual impairment that precludes study participation

Study sites (1)

KY