Feasibility and Acceptability of a Virtual 'Coping With Brain Fog' Intervention for Young Adults With Cancer
NCT ID: NCT05115422
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2021-11-01
2022-10-31
Brief Summary
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Detailed Description
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Objective: The primary objective of this study is to determine the feasibility and acceptability/satisfaction of a virtual 'Coping with Brain Fog' intervention to AYAs with cancer during the COVID-19 pandemic. Secondary objectives of the study are to determine the preliminary effect of the intervention on the cognitive functioning and symptoms of distress (anxiety/depression/fatigue) of AYAs with cancer.
Methods: This prospective pilot study will involve an 8-week virtual "Coping with Brain Fog" program, with one 90-minutes session per week. The 'Coping with Brain Fog' program, developed by Maximum Capacity Inc., has been designed as an in-person group program to educate participants about brain fog and help them enhance their cognition and overall wellbeing. Sessions are designed to enhance memory, task management, and psychological wellbeing skills. Sessions will be delivered over Zoom in a group setting by a Master's-prepared registered social worker and AYA psychosocial oncology clinician at CancerCare Manitoba. Individuals who are between the ages of 18-40 and are (a) diagnosed with any type or stage of cancer, (b) seeking intervention for self-reported symptoms of brain fog (such as poor memory, mental slowness, or task insufficiency), and (c) currently living in Manitoba, Northwestern Ontario or Nunavut, will be eligible for this study. Before starting the intervention, the study participants will be sent a survey link to collect background patient information and measure self-reported cognitive function and symptoms of distress. The participants will also complete a post-intervention questionnaire to measure self-reported cognitive function, symptoms of distress, and satisfaction within one week of completing the intervention and at 6-8 weeks after the intervention. Semi-structured exit phone interviews will be conducted with the participants within two weeks of completing the intervention to collect their narrative feedback and experiences with the intervention.
Significance: This pilot project will help determine the feasibility and acceptability/satisfaction of a virtual 'Coping with Brain Fog' program and measure its preliminary effects on cognitive function and symptoms of distress among AYAs with cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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"Coping with Brain Fog" intervention
'Coping with Brain Fog' program
The proposed intervention is an 8-week 'Coping with Brain Fog' program for cancer survivors, adapted for AYAs with cancer, with one 90-minute group session per week. The intended group size for the program is 8-12 participants. The program was developed to be delivered in person, however for the purposes of this study it will be conducted in a virtual setting. The overall goals of the program are to educate participants about cancer-related brain fog and enhance their cognitive function and wellbeing. To accomplish this, the program is segmented into three main components: memory skills, task management, and psychological wellbeing. For each component, participants are systematically introduced to evidence-based strategies to cumulatively build a repertoire of cognitive tools designed to reduce the impact of cancer-related brain fog. The program uses a manual and participant materials that are copyrighted by Maximum Capacity Inc.
Interventions
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'Coping with Brain Fog' program
The proposed intervention is an 8-week 'Coping with Brain Fog' program for cancer survivors, adapted for AYAs with cancer, with one 90-minute group session per week. The intended group size for the program is 8-12 participants. The program was developed to be delivered in person, however for the purposes of this study it will be conducted in a virtual setting. The overall goals of the program are to educate participants about cancer-related brain fog and enhance their cognitive function and wellbeing. To accomplish this, the program is segmented into three main components: memory skills, task management, and psychological wellbeing. For each component, participants are systematically introduced to evidence-based strategies to cumulatively build a repertoire of cognitive tools designed to reduce the impact of cancer-related brain fog. The program uses a manual and participant materials that are copyrighted by Maximum Capacity Inc.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with any type or stage of cancer
* Seeking intervention for self-reported symptoms of brain fog (such as poor memory, mental slowness, or task insufficiency)
* Must be currently living in Manitoba, Nunavut or Northwest Ontario
* Must be able to attend eight virtual sessions of the 'Coping with Brain Fog' intervention
* Must have reliable access to the internet and the audio-visual platform Zoom
* Should also be able to read, speak and write English (as the sessions will be conducted in English)
Exclusion Criteria
* Must not have a previously diagnosed severe intellectual disability (self-reported by the participants)
* Should not be receiving any new interventions to enhance their cognitive function during the period of this study
* Must attend the first two sessions and should not miss two consecutive sessions (if a participant misses two consecutive sessions due to extenuating circumstances, they will be encouraged to withdraw from the group and be prioritized on the wait-list for the next brain fog group)
18 Years
40 Years
ALL
Yes
Sponsors
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CancerCare Manitoba
OTHER
University of Manitoba
OTHER
Responsible Party
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Sapna Oberoi
Pediatric Hematologist Oncologist
Locations
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CancerCare Manitoba
Winnipeg, Manitoba, Canada
Countries
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References
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Hardy SJ, Krull KR, Wefel JS, Janelsins M. Cognitive Changes in Cancer Survivors. Am Soc Clin Oncol Educ Book. 2018 May 23;38:795-806. doi: 10.1200/EDBK_201179.
Jean-Pierre P, Winters PC, Ahles TA, Antoni M, Armstrong FD, Penedo F, Lipshultz SE, Miller TL, Fiscella K. Prevalence of self-reported memory problems in adult cancer survivors: a national cross-sectional study. J Oncol Pract. 2012 Jan;8(1):30-4. doi: 10.1200/JOP.2011.000231. Epub 2011 Nov 22.
Prasad PK, Hardy KK, Zhang N, Edelstein K, Srivastava D, Zeltzer L, Stovall M, Seibel NL, Leisenring W, Armstrong GT, Robison LL, Krull K. Psychosocial and Neurocognitive Outcomes in Adult Survivors of Adolescent and Early Young Adult Cancer: A Report From the Childhood Cancer Survivor Study. J Clin Oncol. 2015 Aug 10;33(23):2545-52. doi: 10.1200/JCO.2014.57.7528. Epub 2015 Jul 6.
McDougall GJ Jr, Oliver JS, Scogin F. Memory and cancer: a review of the literature. Arch Psychiatr Nurs. 2014 Jun;28(3):180-6. doi: 10.1016/j.apnu.2013.12.005. Epub 2014 Mar 22.
Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24.
Barnett M, McDonnell G, DeRosa A, Schuler T, Philip E, Peterson L, Touza K, Jhanwar S, Atkinson TM, Ford JS. Psychosocial outcomes and interventions among cancer survivors diagnosed during adolescence and young adulthood (AYA): a systematic review. J Cancer Surviv. 2016 Oct;10(5):814-31. doi: 10.1007/s11764-016-0527-6. Epub 2016 Feb 26.
Perales MA, Drake EK, Pemmaraju N, Wood WA. Social Media and the Adolescent and Young Adult (AYA) Patient with Cancer. Curr Hematol Malig Rep. 2016 Dec;11(6):449-455. doi: 10.1007/s11899-016-0313-6.
Anderson C, Nichols HB. Trends in Late Mortality Among Adolescent and Young Adult Cancer Survivors. J Natl Cancer Inst. 2020 Oct 1;112(10):994-1002. doi: 10.1093/jnci/djaa014.
Miller KD, Fidler-Benaoudia M, Keegan TH, Hipp HS, Jemal A, Siegel RL. Cancer statistics for adolescents and young adults, 2020. CA Cancer J Clin. 2020 Nov;70(6):443-459. doi: 10.3322/caac.21637. Epub 2020 Sep 17.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
Tsangaris E, D'Agostino N, Rae C, Breakey V, Klassen AF. Development and Psychometric Evaluation of the Cancer Distress Scales for Adolescent and Young Adults. J Adolesc Young Adult Oncol. 2019 Oct;8(5):566-580. doi: 10.1089/jayao.2019.0005. Epub 2019 Jul 8.
Muthumuni D, Scott I, Chochinov HM, Mahar AL, Garland SN, Schulte F, Lambert P, Lix L, Garland A, Oberoi S. Feasibility and Acceptability of a Virtual "Coping with Brain Fog" Intervention for Improving Cognitive Functioning in Young Adults with Cancer. J Adolesc Young Adult Oncol. 2023 Oct;12(5):662-673. doi: 10.1089/jayao.2023.0022. Epub 2023 May 8.
Related Links
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Related Info
PROMIS Short Form v1.0 - Anxiety 8a
PROMIS Short Form v1.0 - Depression 8b
PROMIS Short Form v1.0 - Fatigue 8a
Other Identifiers
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AYABF2021P
Identifier Type: -
Identifier Source: org_study_id
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