Metastatic Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPathways
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.
Sponsors
National Cancer Institute (NCI)
Laurie McLouth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* new or recurrent stage IIIB, stage IIIC or stage IV non-small cell lung cancer (NSCLC) or extensive stage SCLC * 18 years of age or older * ECOG PS 0-2/Karnofsky 60-100 * 3 to 12 weeks into active cancer treatment
Exclusion criteria
* unstable brain metastases * cognitive or psychiatric condition for which participating would be inappropriate * unable to speak and read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate | 9 months | Percentage of eligible and approached patients who agree to participate |
| Acceptability: Ratings | 9 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Purpose - PROMIS Meaning and Purpose 4a | 9 months | 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. |
| PROMIS Satisfaction With Participation in Social Roles - Short Form 8a | 9 months | 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. |
| Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann) | 9 months | 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. |
| Distress - PROMIS Depression Short Form 6a | 9 months | 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. |
| Hope - State Hope Scale (Snyder) | 9 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Ineligible | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pathways |
|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
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).
Time frame: 9 months
Population: 1 participant skipped this measure so overall number is 39 instead of 40
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pathways | Acceptability: Ratings | Convenience of intervention | 8.79 score on a scale | Standard Deviation 1.17 |
| Pathways | Acceptability: Ratings | Relevance of intervention | 8.46 score on a scale | Standard Deviation 1.67 |
| Pathways | Acceptability: Ratings | Helpfulness of intervention | 8.54 score on a scale | Standard Deviation 1.55 |
Primary
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
Percentage of eligible and approached patients who agree to participate
Time frame: 9 months
Population: 98 potentially eligible people were approached, of whom 53 agreed to participate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathways | Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate | 53 Participants |
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.
Time frame: 9 months
Population: 1 participant skipped this measure so overall number is 39 instead of 40
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pathways | Distress - PROMIS Depression Short Form 6a | 11.3 total raw score on a scale | Standard Deviation 5.87 |
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pathways | Hope - State Hope Scale (Snyder) | 31.3 total score on a scale | Standard Deviation 7.9 |
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pathways | Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann) | 52 total score on a scale | Standard Deviation 15.7 |
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pathways | PROMIS Satisfaction With Participation in Social Roles - Short Form 8a | 21.8 score on a scale | Standard Deviation 9.54 |
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.
Time frame: 9 months
Population: 1 participant skipped this measure so overall number is 39 instead of 40
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pathways | Purpose - PROMIS Meaning and Purpose 4a | 16.4 total raw score on a scale | Standard Deviation 3.7 |