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

NCT05030792 | Completed

• 2 other identifiers: UMCC 2021.056HUM00199671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivorship; Cancer-related Cognitive Impairment

Keywords

Virtual reality; Breast Cancer Survivor; Attention Restorative Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Attrition rate (feasibility)

  6 weeks

• Participant experience assessed using Thematic Analysis

  6 weeks

• Impact of intervention, measured by Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog) questionnaire

  At baseline, week 4 and week 6

Study Arms (2)

ART VR 3 times/week

EXPERIMENTAL

ART VR practice for 30 minutes, at home, 3 times per week

Other: Attention-restorative therapy (ART)-based virtual reality (VR)

ART VR 4 times/week

EXPERIMENTAL

ART VR practice for 30 minutes, at home, 4 times per week

Other: Attention-restorative therapy (ART)-based virtual reality (VR)

Interventions

Attention-restorative therapy (ART)-based virtual reality (VR) OTHER

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.

ART VR 3 times/week; ART VR 4 times/week

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• NRG Oncology: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Noel Arring, DNP, PhD, RN

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: October 26, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)