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NCT Number: NCT04825912

Resilience Measurement in Older Adults With Late-Stage Lung Cancer

The purpose of this study to test measures of physical and psychological resilience while using Self-System therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).

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Key information

Conditions

Lung Cancer Stage III Lung Cancer Stage IV Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

The investigator will examine the feasibility of delivering measures of psychological and physical resilience while delivering the SST intervention. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 or older
  • English-speaking
  • The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her home.

Exclusion criteria

  • Unable to provide informed consent
  • Visual or hearing impairments that preclude participation
  • Serious mental illness

Treatment and study plan

Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience

Behavioral

The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period.

Primary outcomes

  1. Confidence in Behavior as Measured by the Cancer Behavior Inventory

    Time frame: Baseline, 8 weeks, 10 weeks

    The Cancer Behavior Inventory measure will be used for rating confidence in behavior. The measure consist of 12 items. Scores range from 12-108 with higher scores indicating greater confidence.

Secondary outcomes

  1. Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)

    Time frame: Baseline, 8 weeks, 10 weeks

    The Brief COPE measure will be used for rating coping skills related to stress. The measure consists of 28 items. Scores range from 28-112 with higher scores indicating lower stress.

  2. Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)

    Time frame: Baseline, 8 weeks, 10 weeks

    The CD-RISC-25 will be used for measuring resilience. The measure consists of 25 items with a scaling of 0-4. Scores range from 0-100, with higher scores being an indicator of higher resilience.

  3. Depression as Measured by the Beck Depression Inventory (BDI-II)

    Time frame: Baseline, 8 weeks, 10 weeks

    Depression will be measured using the Beck Depression Inventory (BDI-II). The measure consists of 21 items. The BDIII is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3 with a total score range of 0 to 63. Higher scores indicate greater depression.

  4. Positive Affect as Measured by the PANAS (Positive and Negative Scale)

    Time frame: Baseline, 8 weeks, 10 weeks

    The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect.

  5. Negative Affect as Measured by the PANAS (Positive and Negative Scale)

    Time frame: Baseline, 8 weeks, 10 weeks

    The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect.

  6. Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)

    Time frame: Baseline, 8 weeks, 10 weeks

    Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE). The instrument is comprised of 12 self-reported occupational, household and leisure activities items over a one-week period. The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities. The PASE instrument uses frequency, duration, and intensity level of activity over the previous week to assign a score. The overall PASE score ranges from 0 to 793, where a higher score indicates more physical activity.

  7. Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)

    Time frame: Baseline, 8 weeks, 10 weeks

    The Pain Interference PROMIS Scale measure will be used for rating pain interference in daily living. The measure consists of 6 items. Scores range from 6-30, with higher scores indicating higher pain interference.

  8. Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)

    Time frame: Baseline, 8 weeks, 10 weeks

    The Quality-of-Life measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life. The measure will be offered to assess how many total participants complete the measure in its entirety.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Wake Forest University Health Sciences

Registry information

Official study title

Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer

Acronym: SST Resilience

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Feb 2, 2024

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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