An interventional study of Educational Intervention and Educational Intervention in Malignant Neoplasm, sponsored by OHSU Knight Cancer Institute. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Supportive care
This trial studies the use of virtual reality as an educational tool for cancer patients undergoing radiation therapy. The purpose of the study is to learn about virtual reality education (VERT) and if it may be able to help people who are planning to receive radiation therapy. Patient education using virtual reality may result in better understanding and/or decreased anxiety in patients receiving radiation therapy.
PRIMARY OBJECTIVE:
I. To assess if proximal knowledge regarding radiation therapy (RT) treatment is improved as result of radiation therapist-led education sessions utilizing VERT.
SECONDARY OBJECTIVE:
I. To assess if proximal anxiety related to first RT is reduced as result of radiation therapist-led education sessions utilizing VERT.
EXPLORATORY OBJECTIVES:
I. To determine whether self-reported knowledge changes throughout course of RT treatment.
II. To evaluate if self-reported knowledge related to RT treatment differs by patient and tumor characteristics (gender, age, diagnosis, type of cancer, etc.).
III. To determine whether the level of patient knowledge and/or anxiety changes throughout radiation RT treatment.
IV. To evaluate if the level of anxiety related to RT treatment differs by patient and tumor characteristics (gender, age, diagnosis, type of cancer, etc.).
V. To characterize the levels informational support provided by interprofessional RT treatment team needs and knowledge gaps of cancer patients undergoing RT treatment.
VI. To determine the sources of information related to RT treatment being accessed by study participants.
VII. To assess self-reported satisfaction in knowledge gained regarding RT treatment.
VIII. To compare the baseline proximal knowledge and anxiety of Oregon Health and Science University (OHSU) patients with Compass Oncology patients.
OUTLINE: Patients are either randomized to Arm I or 1 of 2 groups of Arm II, or assigned to the observational cohort.
ARM I: Patients complete a radiation therapist-led education module using virtual reality over 30 minutes at the first treatment appointment, prior to radiation therapy treatment.
ARM II: Patients are randomized to 1 of 2 groups.
ARM II CONTROL GROUP I: Patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.
ARM II CONTROL GROUP II: Patients complete a radiation therapist-led face-to-face education module at the first treatment appointment, prior to radiation therapy treatment.
OBSERVATIONAL COHORT: Observational patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.
After completion of study, patients are optionally followed up periodically.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients complete a radiation therapist-led education module using virtual reality over 30 minutes at the first treatment appointment, prior to radiation therapy treatment.
Other: Educational Intervention · Other: Survey Administration
Patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.
Other: Educational Intervention · Other: Survey Administration
Patients complete a radiation therapist-led face-to-face education module at the first treatment appointment, prior to radiation therapy treatment.
Other: Educational Intervention · Other: Survey Administration
Observational patients receive the usual verbal and written education materials at the first treatment appointment, prior to radiation therapy treatment.
Other: Educational Intervention · Other: Survey Administration
Complete radiation therapist-led education module using virtual reality
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive the usual verbal and written education materials
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete radiation therapist-led face-to-face education module
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Knowledge of radiation therapy (RT)
Measured by part 1 of the Radiation Therapy Patient Education Survey by start of RT. The sum of scores from Survey 1.1 for Arm 1 will be compared with that of Arm 2 (using total scores from Survey 1.0 for Arm 2 control group \[CG\]1 and total scores from Survey 1.1 for Arm 2 CG2) using two-sided two-sample t test. Linear regression models will be fitted for adjusted comparison after controlled for disease sites and other important patient and tumor characteristics.
Time frame: Prior to start of planned RT, on the first treatment day up to completion of the virtual reality education (VERT) intervention of planned RT (up to 9 weeks)
Anxiety in radiation therapy
Measured by part 2 of the Radiation Therapy Patient Education Survey by start of RT. The sum of scores from Survey 1.1 for Arm 1 will be compared with that of Arm 2 (using total scores from Survey 1.0 for Arm 2 CG1 and total scores from Survey 1.1 for Arm 2 CG2) using two-sided two-sample t test. Linear regression models will be fitted for adjusted comparison after controlled for disease sites and other important patient and tumor characteristics.
Time frame: Prior to start of planned RT, on the first treatment day up to completion of the VERT intervention of planned RT (up to 9 weeks)
Knowledge in radiation therapy
Measured by part 1 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Anxiety in radiation therapy
Measured by part 2 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Proportion of information contribution by interprofessional team
Measured by part 3 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Frequency/benefits of information sources
Measured by part 4 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Overall satisfaction in knowledge gained regarding RT treatment
Measured by part 5 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
Knowledge and anxiety in radiation therapy
Measured by part 1 and part 2 of the Radiation Therapy Patient Education Survey. Paired t-test will be used to determine if total scores for knowledge and anxiety at the end of RT (as measured in Survey 2.0) differs from before the RT starts (Survey 1.1 for subjects in Arm 1 and Arm 2 CG2, and Survey 1.0 for Arm 2 CG 1). Linear regression model will be used to evaluate the association between change in total scores for knowledge/anxiety at the end of RT from before the RT starts and patient/tumor characteristics.
Time frame: Prior to start of planned RT on the first treatment day up to the last week of planned RT (up to 9 weeks)
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OHSU Knight Cancer Institute