Trial Outcomes & Findings for Piloting Pathways With Lung Cancer Patients (NCT NCT04161157)

NCT ID: NCT04161157

Last Updated: 2023-10-05

Results Overview

Percentage of eligible and approached patients who agree to participate

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

9 months

Results posted on

2023-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	53
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	4
Overall Study Death	3
Overall Study Ineligible	2
Overall Study Withdrawal by Subject	4

Baseline Characteristics

1 participant dropped from the study before baseline measures were collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pathways n=52 Participants 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.
Age, Continuous	61.4 years STANDARD_DEVIATION 10.7 • n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Sex: Female, Male Female	31 Participants n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Sex: Female, Male Male	21 Participants n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 1 participant dropped from the study before baseline measures were collected.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: 98 potentially eligible people were approached, of whom 53 agreed to participate.

Percentage of eligible and approached patients who agree to participate

Outcome measures

Outcome measures
Measure	Pathways n=98 Participants 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.
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate	53 Participants

PRIMARY outcome

Timeframe: 9 months

Population: 1 participant skipped this measure so overall number is 39 instead of 40

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).

Outcome measures

Outcome measures
Measure	Pathways n=39 Participants 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.
Acceptability: Ratings Convenience of intervention	8.79 score on a scale Standard Deviation 1.17
Acceptability: Ratings Relevance of intervention	8.46 score on a scale Standard Deviation 1.67
Acceptability: Ratings Helpfulness of intervention	8.54 score on a scale Standard Deviation 1.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pathways n=40 Participants 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.
PROMIS Satisfaction With Participation in Social Roles - Short Form 8a	21.8 score on a scale Standard Deviation 9.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pathways n=40 Participants 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.
Hope - State Hope Scale (Snyder)	31.3 total score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: 9 months

Population: 1 participant skipped this measure so overall number is 39 instead of 40

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.

Outcome measures

Outcome measures
Measure	Pathways n=39 Participants 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.
Purpose - PROMIS Meaning and Purpose 4a	16.4 total raw score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 9 months

Population: 1 participant skipped this measure so overall number is 39 instead of 40

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.

Outcome measures

Outcome measures
Measure	Pathways n=39 Participants 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.
Distress - PROMIS Depression Short Form 6a	11.3 total raw score on a scale Standard Deviation 5.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pathways n=40 Participants 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.
Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)	52 total score on a scale Standard Deviation 15.7

Adverse Events

Pathways

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laurie McLouth

University of Kentucky

Phone: 859-562-2526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place