Feasibility and Acceptability of a Virtual 'Coping With Brain Fog' Intervention for Young Adults With Cancer

NCT05115422 | Unknown

• 1 other identifier: AYABF2021P
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer-related cognitive problems, also known as "brain fog", have a significant impact on patients with cancer and cancer survivors. Previous studies indicate that cancer and cancer treatments can negatively affect memory, attention and thinking abilities. Adolescents and young adults (AYAs) are individuals with a cancer diagnosis, who are currently between 18 to 40 years old. These individuals are especially vulnerable to brain fog symptoms due to the effect these symptoms have on their education, employment, health behaviors, mental health, and social relationships. There is a clear need for programming directed at brain fog symptoms among AYAs with cancer diagnoses. The 'Coping with Brain Fog' program, developed by Maximum Capacity Inc., is an eight-week group program that has been designed to educate patients about their brain fog symptoms and develop strategies to manage these symptoms. In this study the investigators will aim to determine the feasibility of adapting the 'Coping with Brain Fog' program to the virtual setting for AYAs with cancer during the COVID-19 pandemic. The investigators will also aim to explore the efficacy of the program on cognitive functioning and symptoms of anxiety, depression and fatigue. This study is an important step towards finding ways to treat brain fog symptoms in cancer patients, and could help guide future studies and programs.

Conditions

Cancer; Cognitive Dysfunction; Cognitive Impairment; Adolescents; Young Adults

Keywords

Brain fog; Psychological Distress; Anxiety; Depression; Fatigue

Outcome Measures

Primary Outcomes (2)

• Adherence

  The investigators will measure the adherence to the intervention by measuring attendance at the weekly sessions. The intervention will be considered feasible if 60% of participants do not miss the first two sessions and any two consecutive sessions.

  Adherence will be assessed at the end of the 8-week intervention.

• Participant Satisfaction - Client Satisfaction Questionnaire

  The participants' satisfaction with the program will be measured using The Client Satisfaction Questionnaire (CSQ), an 8-item self-report scale which will be administered at the end of the intervention to assess the participant satisfaction. Each item on this scale is scored from 1 to 4, generating a total score ranging from 8 to 32. A total score of 8-20 indicates low satisfaction, whereas total scores of 21-26 and 27-32 indicate medium and higher satisfaction, respectively.

  Participant Satisfaction will be measured at the end of the 8-week intervention.

Secondary Outcomes (6)

• Perceived Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive Function Scale

  The investigators will measure perceived cognitive functioning before, one week after, and 6-8 weeks after the intervention.

• Perceived Cognitive Functioning - Cancer Distress Scales for Adolescents and Young Adults

  The investigators will measure perceived cognitive functioning before, one week after, and 6-8 weeks after the intervention.

• Symptoms of Distress and Fatigue - Anxiety

  The investigators will measure symptoms of distress before, one week after, and 6-8 weeks after the intervention.

• Symptoms of Distress and Fatigue - Depression

  The investigators will measure symptoms of distress before, one week after, and 6-8 weeks after the intervention.

• Symptoms of Distress and Fatigue - Fatigue

  The investigators will measure symptoms of distress before, one week after, and 6-8 weeks after the intervention.

Study Arms (1)

"Coping with Brain Fog" intervention

EXPERIMENTAL

Behavioral: 'Coping with Brain Fog' program

Interventions

'Coping with Brain Fog' program BEHAVIORAL

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.

"Coping with Brain Fog" intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years
• 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)

You may not qualify if:

• Age younger than 18 or older than 40 years at the time of enrollment
• 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)

Sponsors & Collaborators

• University of Manitoba: lead
• CancerCare Manitoba: collaborator

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Related Publications (12)

• 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.

  PMID: 30231372 BACKGROUND

• 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.

  PMID: 22548008 BACKGROUND

• 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.

  PMID: 26150441 BACKGROUND

• 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.

  PMID: 24856270 BACKGROUND

• 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.

  PMID: 23008308 BACKGROUND

• 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.

  PMID: 26920873 BACKGROUND

• 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.

  PMID: 26893061 BACKGROUND

• 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.

  PMID: 32123906 BACKGROUND

• 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.

  PMID: 32940362 BACKGROUND

• 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.

  PMID: 10245370 BACKGROUND

• 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.

  PMID: 31274372 BACKGROUND

• 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.

  PMID: 37158780 DERIVED

Related Links

• Related Info
• PROMIS Short Form v1.0 - Anxiety 8a
• PROMIS Short Form v1.0 - Depression 8b
• PROMIS Short Form v1.0 - Fatigue 8a

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction; Mental Fatigue; Anxiety Disorders; Depression; Fatigue

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hematologist Oncologist

Model Details: Pilot study of the virtual 'Coping with Brain Fog' intervention for AYAs with cancer living in Manitoba.

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: November 10, 2021
• Study Start: November 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)