Clinical trial NCT05030792: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivorship
Cancer-related Cognitive Impairment
Keywords: Virtual reality
Breast Cancer Survivor
Attention Restorative Therapy
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: NRG Oncology
First posted: 2021-09-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Adherence rate (acceptability)
timeFrame: 6 weeks
Secondary outcomes:
measure: Attrition rate (feasibility)
timeFrame: 6 weeks
measure: Participant experience assessed using Thematic Analysis
timeFrame: 6 weeks
measure: Impact of intervention, measured by Functional Assessment of Cancer Therapy-Cognitive Function (Fact-Cog) questionnaire
timeFrame: At baseline, week 4 and week 6
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Noel Arring, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: