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| ID | Type | Description | Link |
|---|---|---|---|
| R03CA235171-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.
In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathways | Experimental | Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pathways | Behavioral | Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate | Percentage of eligible and approached patients who agree to participate | 9 months |
| Acceptability: Ratings | Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability). | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Satisfaction With Participation in Social Roles - Short Form 8a | Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie McLouth, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pathways | Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. Pathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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53 participants were enrolled in the study; however, 1 participant dropped from the study before baseline measures were collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pathways | Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. Pathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant dropped from the study before baseline measures were collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate | Percentage of eligible and approached patients who agree to participate | 98 potentially eligible people were approached, of whom 53 agreed to participate. | Posted | Count of Participants | Participants | 9 months |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pathways | Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. Pathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurie McLouth | University of Kentucky | 859-562-2526 | laurie.mclouth@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 18, 2022 | Jul 28, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 9 months |
| Hope - State Hope Scale (Snyder) | Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope. | 9 months |
| Purpose - PROMIS Meaning and Purpose 4a | Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose. | 9 months |
| Distress - PROMIS Depression Short Form 6a | Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress. | 9 months |
| Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann) | measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma. | 9 months |
| Withdrawal by Subject |
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| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | 1 participant dropped from the study before baseline measures were collected. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 1 participant dropped from the study before baseline measures were collected. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Acceptability: Ratings | Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability). | 1 participant skipped this measure so overall number is 39 instead of 40 | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Secondary | PROMIS Satisfaction With Participation in Social Roles - Short Form 8a | Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
|
|
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| Secondary | Hope - State Hope Scale (Snyder) | Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope. | Posted | Mean | Standard Deviation | total score on a scale | 9 months |
|
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| Secondary | Purpose - PROMIS Meaning and Purpose 4a | Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose. | 1 participant skipped this measure so overall number is 39 instead of 40 | Posted | Mean | Standard Deviation | total raw score on a scale | 9 months |
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| Secondary | Distress - PROMIS Depression Short Form 6a | Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress. | 1 participant skipped this measure so overall number is 39 instead of 40 | Posted | Mean | Standard Deviation | total raw score on a scale | 9 months |
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| Secondary | Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann) | measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma. | Posted | Mean | Standard Deviation | total score on a scale | 9 months |
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| 3 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
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