Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOHSU Knight Cancer Institute

About this trial

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AIM 1: Suspected lung cancer

AIM 1: English fluency

AIM 1: > 6-month life expectancy

AIM 1: Score of ≥ 3 on the cognitive impairment screener

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive standard of care

  • Health Promotion and Education

    Other intervention

    View decision aid

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Group I (decision aid)Experimental treatment 2 interventions
Group B: Group II (standard of care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Decision Conflict

Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.

Time frame
Up to 6 months
2

Efficacy of a conversation tool on patients' knowledge of lung cancer

Will be assessed using nine questions from previously validated measures.

Time frame
Up 6 months
3

Satisfaction with Communication/Confidence in Decision

Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.

Time frame
Up to 6 months
4

Self-Efficacy

Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.

Time frame
Up to 6 months

Secondary outcomes

1

FACT-L

Quality of Life will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.

Time frame
Up to 6 months.
2

Depression/Anxiety

Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression.

Time frame
Up to 6 months
3

Participation in Decision-Making

Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as "patient controlled", answers of 3 are categorized as "shared", and answers of 4 or 5 are categorized as "physician-controlled."

Time frame
Up to 6 months
4

Decision Regret

Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

American Cancer Society, Inc.

Collaborator