An Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cancer-related Cognitive Impairment; Breast Cancer Survivorship
• Intervention / Treatment: Other: Attention-restorative therapy (ART)-based virtual reality (VR)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ART VR 3 times/week; ART VR practice for 30 minutes, at home, 3 times per week	Other: Attention-restorative therapy (ART)-based virtual reality (VR); 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.
Experimental: ART VR 4 times/week; ART VR practice for 30 minutes, at home, 4 times per week	Other: Attention-restorative therapy (ART)-based virtual reality (VR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: NRG Oncology
• Investigators: Principal Investigator: Noel Arring, DNP, PhD, RN, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Virtual reality; Breast Cancer Survivor; Attention Restorative Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Skin Diseases; Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Breast Diseases; Cognition Disorders; Breast Neoplasms; Cognitive Dysfunction
• Other Study ID Numbers: UMCC 2021.056; HUM00199671 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No