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Completed

NCT Number: NCT04057196

Self-System Therapy for Older Adults With Lung Cancer

The purpose of this study to use 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

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 whether delivering the SST intervention will be both feasible and acceptable to study participants. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall 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 years
  • English-speaking
  • The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his 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)

Behavioral

The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC 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.

Primary outcomes

  1. Number of Patients That Complete SST Treatment Sessions

    Time frame: up to week 12

    Completion of at least 85% of SST treatment sessions across a 12-week period.

  2. Patient Satisfaction With Treatment

    Time frame: End of study, week 12

    The Client Satisfaction Questionnaire (CSQ-8), which assesses treatment credibility (pre-treatment) and effectiveness of/satisfaction with services (post-treatment). An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction.

Secondary outcomes

  1. General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline

    Time frame: Baseline

    The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.

  2. General Distress as Measured by the CORE-10 at 12 Weeks

    Time frame: 12 weeks

    The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.

  3. General Distress as Measured by the CORE-10 at 1-month Follow-up

    Time frame: 1-month follow-up, up to 4 months

    The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.

  4. Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline

    Time frame: Baseline

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

  5. Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks

    Time frame: 12 weeks

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

  6. Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up

    Time frame: 1-month follow-up, up to 4 months

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

  7. Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)

    Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)

    Functioning will be measured using the Functional Assessment of Cancer Therapy- Lung (FACT-L). The FACT-L is a 36-item measure, each item with a five-point scale from 0 (not at all) to 4 (very much), measuring overall quality of life (QOL) across five dimensions that are summed together to derive a total score. The total score range is from 0-136. The higher the score, the better the QOL.

  8. Number of Participants With Participant-reported Mobility Indices Available

    Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)

    Mobility indices will include participant report of difficulty walking across a room without help from another person or equipment (none, a little vs some, a lot, unable), difficulty walking two to three blocks without help from another person or equipment (none, a little vs some, a lot, unable), and use of assistive device (yes vs no).

  9. Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available

    Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)

    Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE)The instrument is comprised of self-reported occupational, household and leisure activities items over a one-week period. PASE scores are calculated from weights and frequency values for each of 12 types of activity.

  10. Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline

    Time frame: Baseline

    Self-Discrepancy will be measured using the Computerized Selves Questionnaire (CSQ). The CSQ is a computer-based version of the original self-discrepancy questionnaire used by Higgins and colleagues (1986) in which a person is asked to produce a list of eight personal attributes that s/he would ideally like to possess and eight attributes s/he feels s/he ought to possess. To score, qualities in the actual self column are compared with those in the ought self column.

  11. Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline

    Time frame: Baseline

    Self-Regulatory Orientation will be measured using the Regulatory Focus Questionnaire (RFQ).The measure has 11 items using 5-point scales, along two sub scales measuring the extent to which an individual believes s/he has been successful in attaining promotion or prevention goals. Six questions quantify Promotion and five questions quantify Prevention the promotion sums must be divided by 6, and the prevention sums must be divided by 5 in order to place scores for both orientations on the same 1-5 scale.

  12. Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.

    Time frame: End of study, week 12

    Trained raters will listen to audio recordings of treatment sessions and use a pre-defined checklist of session content and strategies of the treatment to indicate if session coping skills were taught (yes/no) coded as 1 for yes and 0 for no. Higher scores indicate greater session fidelity.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2019
Registry last updated
Aug 3, 2022

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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