Back to resultsAn Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors
Primary Purpose
Breast Cancer Survivorship, Cancer-related Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention-restorative therapy (ART)-based virtual reality (VR)
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Survivorship focused on measuring Virtual reality, Breast Cancer Survivor, Attention Restorative Therapy
Eligibility Criteria
Inclusion Criteria:
- Female
- Age ≥18
- Stage I-III breast cancer
- Reports a negative change in cognitive function since their cancer diagnosis and rate their cognitive fatigue using a single item questions as a ≥4 on a numeric rating scale of 0-10 for 1 month or more.
- Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months but no more than 10 years prior to registration.
- May use concurrent adjuvant endocrine therapy and/or HER2-targeted therapy while on study.
- Ability to provide informed written consent.
- Ability to read and write English.
- Ability to be independent in decision making. Must respond No to "Do you have a guardian or blanket power of attorney for legal transactions?"
Exclusion Criteria:
- Other therapies intended to treat CRCI (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per criteria of 4 or more on a 0 to 10 scale).
- Antidepressants (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per inclusion criteria).
- Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days).
- Psychiatric disorder such as severe depression, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
- Pain requiring opioid pain medication.
- Electronic implanted medical device (e.g. pacemaker).
- History of motion sickness within 5 years prior to enrollment will require a tolerability test at baseline.
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ART VR 3 times/week
ART VR 4 times/week
Arm Description
ART VR practice for 30 minutes, at home, 3 times per week
ART VR practice for 30 minutes, at home, 4 times per week
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT05030792
First Posted
August 30, 2021
Last Updated
November 2, 2022
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
NRG Oncology
1. Study Identification
Unique Protocol Identification Number
NCT05030792
Brief Title
An Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors
Official Title
An Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
NRG Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 Go™ 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivorship, Cancer-related Cognitive Impairment
Keywords
Virtual reality, Breast Cancer Survivor, Attention Restorative Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ART VR 3 times/week
Arm Type
Experimental
Arm Description
ART VR practice for 30 minutes, at home, 3 times per week
Arm Title
ART VR 4 times/week
Arm Type
Experimental
Arm Description
ART VR practice for 30 minutes, at home, 4 times per week
Intervention Type
Other
Intervention Name(s)
Attention-restorative therapy (ART)-based virtual reality (VR)
Intervention Description
The ART-based VR intervention will be provided using an Oculus Go™ which is a commercially available, all-in-one VR headset with a handheld controller.
Primary Outcome Measure Information:
Title
Adherence rate (acceptability)
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Attrition rate (feasibility)
Description
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).
Time Frame
6 weeks
Title
Participant experience assessed using Thematic Analysis
Description
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.
Time Frame
6 weeks
Title
Impact of intervention, measured by Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog) questionnaire
Description
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.
Time Frame
At baseline, week 4 and week 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age ≥18
Stage I-III breast cancer
Reports a negative change in cognitive function since their cancer diagnosis and rate their cognitive fatigue using a single item questions as a ≥4 on a numeric rating scale of 0-10 for 1 month or more.
Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months but no more than 10 years prior to registration.
May use concurrent adjuvant endocrine therapy and/or HER2-targeted therapy while on study.
Ability to provide informed written consent.
Ability to read and write English.
Ability to be independent in decision making. Must respond No to "Do you have a guardian or blanket power of attorney for legal transactions?"
Exclusion Criteria:
Other therapies intended to treat CRCI (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per criteria of 4 or more on a 0 to 10 scale).
Antidepressants (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per inclusion criteria).
Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days).
Psychiatric disorder such as severe depression, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
Pain requiring opioid pain medication.
Electronic implanted medical device (e.g. pacemaker).
History of motion sickness within 5 years prior to enrollment will require a tolerability test at baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Arring, DNP, PhD, RN
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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An Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors
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