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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00199671 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| NRG Oncology | OTHER |
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This study is to assess the feasibility of using a Virtual Reality (VR) headset to provide nature-based Attention-Restorative Therapy (ART) as treatment for cognitive impairment in post-treatment cancer survivors. At ART's foundation is the belief that exposure to nature can improve attention by fully engaging a person in a safe and relaxing experience. This intervention uses a VR headset to expose the participant to nature while overcoming some potential barriers of nature-based interventions like access, physical ability, and bad weather. The goal of this study is to understand if people are willing to use the VR headsets to experience nature virtually, if they find it helpful with cancer-related cognitive impairments (CRCI) symptoms and if they are satisfied with using it. Participants will be asked to use self-management materials (weekly home practice logs, Oculus Goâ„¢ and online questionnaires) for 6 weeks. Investigators hope to use information from this small feasibility study to study the effectiveness of the intervention in a larger group of cancer survivors and ultimately to help cancer survivors struggling with cognitive impairments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART VR 3 times/week | Experimental | ART VR practice for 30 minutes, at home, 3 times per week |
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| ART VR 4 times/week | Experimental | ART VR practice for 30 minutes, at home, 4 times per week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention-restorative therapy (ART)-based virtual reality (VR) | Other | The ART-based VR intervention will be provided using an Oculus Goâ„¢ which is a commercially available, all-in-one VR headset with a handheld controller. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate (acceptability) | Adherence will be measured using weekly home practice logs in which participants will record the frequency and duration of their ART-VR exposure. Adherence will be calculated by arm and is defined in arm 1 as using the VR intervention ≥14.4 times (≥432 minutes) over the course of the study. In arm 2, adherence is defined as using the VR intervention ≥19.2 times (≥576 minutes) over the course of the study. The intervention will be considered acceptable if the adherence rate is 80% or more in either arm (or both arms). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition rate (feasibility) | Included in the attrition count will be anyone who does not provide response to the Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog) questionnaire during week 6 of the study. The intervention will be considered feasible if the attrition rate is 25% or less in either arm (or both arms). | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Arring, DNP, PhD, RN | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| Participant experience assessed using Thematic Analysis | During week 6, research staff will record (either via audio or HIPAA-compliant video platform) participant responses to a set of 6 participant experience questions. Responses will be transcribed and reviewed by two study team members. The research team will then connect the codes to try to identify themes for participant experience. Data analysis will be grounded in the theory of Thematic Analysis, which has been proven to be an effective framework for uncovering meaning in qualitative data. | 6 weeks |
| Impact of intervention, measured by Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog) questionnaire | Fact-Cog is a 37-item scale with 4 subscales (Perceived Cognitive Impairments, Impact of Perceived Cognitive Impairments on QoL, Comments from Others, Perceived Cognitive Abilities) with a 7-days recall. Effect sizes for the FACT-Cog and subscales will be calculated for each arm from baseline to week 6. Data will be summarized using descriptive statistics. | At baseline, week 4 and week 6 |