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NCT Number: NCT06047301

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

Laurie McLouth, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PATHWAYS

Behavioral

Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.

Enhanced Usual Care

Behavioral

Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.

Primary outcomes

  1. Change in PROMIS Depression Short Form Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30.

    Higher scores indicate more depression.

  2. Change in State Hope scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.

Secondary outcomes

  1. Change in PROMIS Anxiety Short Form Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Anxiety symptoms are measured using the PROMIS Anxiety Short Form 4a. 4 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 4 to 20. Higher scores indicate more anxiety.

  2. Change in Demoralization Scale II Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Demoralization symptoms are measured using the Demoralization Scale II: 16 items are responded to on a scale of 0 = never to 2 = always; Raw scores range from 0-32. Higher scores indicate more demoralization.

  3. Change in PROMIS 15a positive affect scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Positive affect is measured using the PROMIS 15a positive affect form. Higher scores indicate more positive affect. Items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 15 to 45. Higher scores indicate more positive affect.

  4. Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Meaning/Peace is measured using the FACIT-Spiritual Well-being Meaning/Peace Subscale. 8 items are responded to on a scale of 0 = not at all to 4 = very much. Raw scores range from 0-32. Higher scores indicate more meaning/peace.

  5. Change in FACT-G7 Quality of Life Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Quality of Life is measured using the FACT-G7. 7 items are responded to on a scale of 0 = not at all to 4 = very much to assess physical, emotional, and functional wellbeing. Raw scores range from 0 to 28. Higher scores indicate better quality of life.

  6. Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores

    Time frame: 12 weeks (Baseline, Post-Intervention)

    Satisfaction with Social Activities and Roles is measured using the ROMIS Satisfaction with Participation in Social Roles 8a Short Form. 8 items are responded to on a scale of 1 = not at all to 5 = very much. Raw scores range from 8 to 40. Higher scores indicate better function.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie McLouth, PhD

CONTACT

[email protected]

859-562-2526

Sponsors and collaborators

Lead sponsor

Laurie McLouth

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
May 8, 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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