Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-30 @ 9:09 AM
Study NCT ID:
NCT04278534
Status:
TERMINATED
Last Update Posted:
2023-08-30
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for the Education of Cancer Patients Undergoing Radiation Therapy
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial to Assess the Effectiveness of Virtual Reality in Education for Cancer Patients Undergoing Radiation Therapy
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: