Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

This arm includes patients who view the integrated health video that provides information about both smoking and environmental risk.

This arm includes patients who view the integrated health video that provides information ONLY about smoking risk.

This intervention is an integrated health video provides individual (smoking) and environmental risk communication on intention to obtain lung cancer screening.

Intervention video

This intervention is an integrated health video provides individual (smoking) risk communication on intention to obtain lung cancer screening.

Control video

Katharine Rendle, PhD,MSW,MPH

Andy Tan, PhD,MPH,MBA

Project PLUS is a pilot study that aims to develop and obtain preliminary feasibility and efficacy data on an enhanced risk communication approach to promote lung cancer screening (LCS) intentions among screening-eligible individuals from environmentally burdened communities. Project PLUS will combine qualitative interviews to explore subject awareness regarding lung cancer risk and air pollution, barriers to LCS, and perceptions regarding risk communication messaging, develop a health education video, and a between-subjects experiment to compare Data from this pilot will form the basis for enhanced community engagement efforts and subsequent communication research to examine the effectiveness of incorporating the involuntary air pollution risk information in risk communication interventions. The long term goal is to reduce lung cancer burden and disparities among environmentally burdened communities within and outside of Philadelphia.

Project PLUS is a pilot study that aims to develop and obtain preliminary feasibility and efficacy data on an enhanced risk communication approach to promote lung cancer screening (LCS) intentions among screening-eligible individuals from environmentally burdened communities. Project PLUS will combine qualitative interviews to explore subject awareness regarding lung cancer risk and air pollution, barriers to LCS, and perceptions regarding risk communication messaging, develop a health education video, and a between-subjects experiment to compare Data from this pilot will form the basis for enhanced community engagement efforts and subsequent communication research to examine the effectiveness of incorporating the involuntary air pollution risk information in risk communication interventions. The long term goal is to reduce lung cancer burden and disparities among environmentally burdened communities within and outside of Philadelphia.

This study is guided by the Health Belief Model and the Reasoned Action Approach.1 The study team will engage with two community partner organizations (Chester Environmental Partnership and Clean Water Action) to obtain feedback in implementing the study procedures and input on content for the health education video. The long-term goal is to improve LCS and reduce racial, ethnic, and socioeconomic disparities in lung cancer mortality.

Project PLUS Lung Cancer Screening Promotion

Project PLUS- Promoting Lung Cancer Screening Among Screening-Eligible Individuals in Environmentally Burdened Communities Through Enhanced Risk Communication

This outcome will be measured using a post-test survey given to patients immediately after viewing a health education video assessing the patient's intention to obtain a lung cancer screening within the next 3 months.

The study team will utilize chart review and medical record data to assess whether patients scheduled or received a lung cancer screening within 6 months of enrollment in the study.

Abramson Cancer Center at Penn Medicine

Assistant Professor

Control video - no advance care planning content

This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.

Advance care planning video

This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.

Rebecca A Aslakson, MD PhD

Through close engagement with our patient and family member co-investigators, the investigators have developed a video-based advance care planning aid for cancer patients and their family members who are preparing for major surgery. In this study, patients are randomized to see either the intervention video (involving advance care planning-related content) or a control video (no advance care planning-related content) prior to surgery. The investigators hypothesize that the video will lead to more and better preoperative discussions between the patient and surgeon that are related to advance care planning. The investigators also hypothesize that seeing the advance care planning-related video will decrease perioperative anxiety and depression scores.

Many cancer patients pursue aggressive surgery in the hope of cancer cure or life prolongation. However, in doing so, patients and families may avoid advance care planning; they do not discuss specific goals and wishes should disease progress despite surgery. Moreover, a subset of patients become critically ill following surgery, and family members must make life-and-death decisions without knowing patient wishes. Preoperative advance care planning-facilitating patient and family discussions concerning perioperative goals, hopes, and fears-could empower patients and families to better choose which therapies and procedures they want outside of the initial surgery and for the months following surgery. Advance care planning aids exist, but none were developed for or evaluated in a surgical patient population. Furthermore, video-based advance care planning tools are an innovative way to better empower patients and families. Previous research shows that, with the aid of an advance care planning video, patients and families are more knowledgeable about treatment options and more comfortable with making decisions. Moreover, when better educated, these patients and families frequently choose less aggressive therapies.

However, video-based advance care planning tools have not been developed or tested in a surgical patient population. The investigators have developed and now will evaluate a video-based advance care planning aid for cancer patients and families pursing aggressive surgical cancer treatment. The investigators hypothesize that, in patients and family members, the video-based decision aid will facilitate better preoperative discussions about advance care planning between the patient and surgeon and decrease anxiety and depression after surgery.

Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families

Through mandated reporting by the Patient-Centered Outcomes Research Institute (PCORI), our data will be shared via their website.

The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.

The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual's dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.

This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).

This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was "Cure my medical condition." We have reported the number of participants in each group who selected this goal at each time point.

This Likert scale evaluates respondent beliefs about the helpfulness of the video.

This Likert scale evaluates respondent beliefs about their comfort in viewing the video.

This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.

The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.

This tracks which participants report having named a surrogate decision maker

This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.

Patient-Centered Outcomes Research Institute

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Advance care planning video

Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.

Intervention

Control video - no advance care planning content

Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Primary Diagnosis

Rebecca Aslakson, M.D., Ph.D.

Death (Long-Term)

Goals

Video

Alternate Medical Decision Maker

Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference.

Measured ACP Content in the Presurgical Consent Visit

We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).

Audio recordings of a presurgical consent visit conversation between a surgeon and patient.

Measured Patient Centeredness in the Presurgical Consent Visit

Baseline Visit (V1)

Presurgical Consent Visit (V2)

Postsurgical One Week Visit (V3)

Postsurgical One Month Visit (V4)

At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.

Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period

At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.

Iowa Goals of Care Across Study Arms Throughout the Study Period

Helpfulness of the Video Across Study Arms

Comfort With the Video Across Study Arms

Recommendation of the Video to Others Across Study Arms

Patient Self-Reported Satisfaction

Surgeon Self-Reported Satisfaction

In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients.

Patient and Provider Satisfaction Scores Across Study Arms

Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period

This question was only asked to participants who reported having designated a medical decision maker.

Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period

Overall Study

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

The educational video on skin cancer for cosmetologists

A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer

Educational video

A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer

Lori A Fischbach (co-Principal Investigator), PhD

Assess the efficacy of training cosmetology students to detect suspicious skin lesions.

The incidence of melanoma is increasing the USA. The early detection of skin cancer is associated with a significant decrease in morbidity and mortality. Hair professionals (cosmetologists and barbers) have an excellent opportunity to detect suspicious skin lesions on the scalp, neck, and face due to routinely looking at this area during customer visits. Currently in Arkansas, cosmetology schools teach students about how to recognize skin cancer on their clients. In this program, the aim was to improve the educational module for skin cancer in schools of cosmetology in Arkansas. In the proposed study, the intervention training module was designed to increase the knowledge of cosmetology schools students about skin cancer will be evaluated. It was hypothesized that this educational video will educate cosmetology students and cosmetologists about how to prevent skin cancer, how to recognize a suspicious spot or mole which may be a skin cancer, and how to talk with clients about seeing a dermatologist when a suspicious spot is found. This study was a cluster-randomized controlled trial in cosmetology schools in Arkansas. The institutional review board for human subjects at the University of Arkansas for Medical Sciences determined that this study was approved as exempt and submission was not required since it was an educational intervention to improve the quality of an educational component of the existing curriculum.

The study design protocol is as follows: Schools of cosmetology in Arkansas are randomized using simple randomization to receive either 1) our educational video on skin cancer for cosmetologists or 2) a publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer. Students view the video that was randomly assigned to the school they attended. Pre-video tests are administered at the school during classes or online at the students' convenience; the video intervention follows immediately, also during classes or online. Post-video test (in class or online) are administered 3 to 6 months after watching the video. All schools continued to also use their previous educational materials on skin cancer concurrent with our program.

Cosmetology Students and Skin Cancer

Scale name: Change in students' scores for knowledge of skin cancer, risk factors, and recognizing an abnormal skin spot. What scale measures: Scores were computed as the proportion of questions that the student correctly answered, and change in scores was computed by subtracting the pre-test score from the post-test score. If a student correctly answered a greater proportion of questions on the post-test compared to the pre-test, then they would have a positive value for the change in scores, and would be classified as increasing their knowledge. Scale ranges: The change in scores range from -100% to 100%; a change \>0% is considered to be an increase in score and a better outcome, whereas change \<0% is considered to be a decrease or a worse outcome. Subscales: The 3 subscales are: 1) knowledge of skin cancer, 2) risk factors, and 3) recognition of abnormal spots. The total number of correct answers are summed and divided by the total number of questions to calculate the total score.

Name of scale: Change in students' perceived importance, interest in, and confidence in looking for abnormal skin spots. What scale measures: Students selected from the following for perceived importance, interest in, and confidence in looking for abnormal skin spots: i)not at all; ii)slightly/a little bit; iii)somewhat; iv)definitely; or v) very/extremely important/interested in/confidence in (where i represents the lowest level and v represents the highest level). Self-reported post-tests were compared to pre-tests. If the amount of the self-reported importance, interest in or confidence was higher on the post-test compared to the pre-test, then it is considered an increase and a better outcome. Scale ranges: The change for perceived importance, interest in, and confidence in looking for abnormal skin spots were classified only as an increase (better outcome) or not (worse outcome).

Name of scale: Change in indoor tanning, outdoor tanning, sunscreen and hat use. What scale measures: Students were asked to select from the following frequencies for tanning: 3-7 times per week, 1-2 times per week, 3-7 times in the last 2 months, 1-2 times in the last 2 months, none in the last 2 months. Students selected from the following for hat/sunscreen use: everyday, 1-6 times per week, 1-3 times per month, \<1 time per month, or never. If the frequency of tanning was lower on the post-test compared to the pre-test, then it was classified as a decrease (which is a better outcome). If the frequency of sunscreen use/hat use was higher on the post-test compared to the pre-test, then it was classified as an increase (which is a better outcome). Scale range: The change for sunscreen/hat use was classified only as increasing (the better outcome) or not (the worse outcome); the change in tanning use was classified only as decreasing (the better outcome) or not (the worse outcome).

Outcomes: Change in looking for abnormal skin spots, talking with clients about skin cancer prevention, and recommending a client see a doctor when an abnormal spot is seen. Students selected from the following proportion of clients in the last month they looked at for abnormal spots: none, \<25%, 25-50%, 51-75%, or \>75%; if the frequency for looking for abnormal spots reported on the post-test was greater than on the pre-test, then there was an increase (better outcome). Students also reported whether they discussed skin cancer prevention as either 'yes' or 'no', and whether or not they had ever recommended that a client see a doctor for an abnormal skin spot. Other outcomes were whether or not students reported on the post-test they looked for abnormal spots on \>50% and \>75% of their clients. Talking with clients about skin cancer prevention, and recommending a client see a doctor was increased (a better outcome) if they responded 'no' on the pre-test and 'yes' on the post-test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Project PLUS Lung Cancer Screening Promotion	NCT05937399	Lung Cancer	Intervention vi... Control video	50 Years - 80 Years	Abramson Cancer Center at Penn Medicine
Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families	NCT02489799	Cancer	Advance care pl... Control video	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cosmetology Students and Skin Cancer	NCT03673917	Skin Cancer	Educational vid... Control video	18 Years -	University of Arkansas
Cosmetology Students and Skin Cancer	NCT03673917	Skin Cancer	Educational vid... Control video	18 Years -	University of Arkansas

Spots Global Cancer Trial Database for control video