Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment

NCT04210778 | Completed

• 1 other identifier: CRCI-HMO-CTIL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed. Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.

Conditions

Cognitive Decline; Cancer

Keywords

Cancer related cognitive impairment; Telerehabilitation; Computerized Cognitive training; Adult cancer survivors; Functional treatment

Outcome Measures

Primary Outcomes (3)

• Change in the Canadian Occupational Performance Measure (COPM) (Law et al., 1998)

  A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with their level of participation in daily functioning regarding the five most important problems they identified. The patient rates each problem on a 10-point scale indicating his level of performance (1= not able to do it at all, 10= able to do it extremely well) and level of satisfaction (1= not satisfied at all, 10 = extremely satisfied). Change is assessed by administering the interview at different time points.

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in Computerized Cognitive Assessments (Posit Science)

  Computerized Assessment will be used to assess neuro-cognitive function using five different tasks from posit science. Domains that will be assessed are sustained attention, visual working memory, speed of processing (visual and auditory) and flexibility

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in Functional Assessment of Cancer Therapy - Cognition (FACT COG) (Jacobs, Jacobsen, Booth-Jones, Wagner, & Anasetti, 2007)

  A self-report questionnaire for cancer patients with cognitive function issues. The tool includes 37-items assessing memory, concentration, language and thinking abilities. The items are grouped into 4 subscales: perceived cognitive impairment (PCI), perceived cognitive abilities (PCA), comments from others (OTH), and impact on quality of life (QOL). The items are rated on a 5-point Likert scale (0=never, 4 =several times a day) regarding the past 7 days, higher scores indicating greater QOL.

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

Secondary Outcomes (9)

• Change in the Functional Assessment of Cancer Therapy-General practice (FACT-GP) (Cella et al., 1993)

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in the Patient Health Questionnaire (PHQ-9)(Kroenke, Spitzer, & Williams, 2001)

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in the Generalized Anxiety Disorder (GAD -7) (Spitzer, Kroenke, Williams, & Löwe, 2006)

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in the Ruminative Response Scale (RRS) (Treynor, Gonzalez, & Nolen-Hoeksema, 2003)

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

• Change in the Functional Assessment of Cancer Therapy - Fatigue (FACT -F) (Yellen, Cella, Webster, Blendowski, & Kaplan, 1997)

  Time 0: Baseline, before group allocation and intervention; Time 1: at completion of intervention, an average of 15 weeks after T0; Time 2: 3 months after Time 1 (an average of 6 months after enrollment)

Study Arms (3)

CRAFT (Cognitive Training and Functional Treatment)

EXPERIMENTAL

Over 12 weeks this group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training, in addition to a weekly 1 hour remote CO- OP (Meta cognitive strategy training) session. Each participant will set three occupational goals that will be the focus of the CO -OP treatment

Behavioral: Cognitive orientation to daily occupational performance (CO-OP); Behavioral: Computerized Cognitive Training (BrainHQ, posit science)

Computerized Cognitive Training

ACTIVE COMPARATOR

This group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training

Behavioral: Computerized Cognitive Training (BrainHQ, posit science)

Treatment As Usual

NO INTERVENTION

This group will receive no intervention

Interventions

Cognitive orientation to daily occupational performance (CO-OP) BEHAVIORAL

The CO-OP is a client-centered, goal directed approach aimed at enabling individuals to identify strategies that will improve daily function. A Weekly (1hr) session is delivered remotely via video conferencing.

CRAFT (Cognitive Training and Functional Treatment)

Computerized Cognitive Training (BrainHQ, posit science) BEHAVIORAL

The BrainHQ training targets multiple cognitive domains. The training will be delivered remotely, using a web-based program. Training progresses in an adaptive, individualized manner, based on individual progression of each participant . Participants are required to practice a minimum of half hour, three times a week (total of 1.5hr)

CRAFT (Cognitive Training and Functional Treatment); Computerized Cognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18;
• Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment. This will be obtained by asking participants the question "do you have concerns about your memory or other thinking abilities following cancer treatment?". Participants are required to answer yes to this question.
• interested in treatment and state they have 2 weekly hours available for the intervention.
• Completion of active treatment for non-Central Nervous System (CNS) cancer (e.g., chemotherapy,radiation therapy and surgery) 6 months or more in the past.
• Cognitive decline with no dementia: 21\<Mini-Mental State Examination \<27 (Folstein, Folstein, \& McHugh, 1975) and/or 19\< Montreal Cognitive Assessment \<26 (Nasreddine et al., 2005);
• Daily access to a computer and Internet facilities;
• Able to sign an informed consent;
• Stable psychiatric condition (according to participants self- report and medical file).

You may not qualify if:

• no prior experience using computers;
• pregnancy;
• History of a central nervous system tumor.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Israel cancer research fund: collaborator
• Israel Cancer Association: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (8)

• Von Ah D, Carpenter JS, Saykin A, Monahan P, Wu J, Yu M, Rebok G, Ball K, Schneider B, Weaver M, Tallman E, Unverzagt F. Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat. 2012 Oct;135(3):799-809. doi: 10.1007/s10549-012-2210-6. Epub 2012 Aug 24.

  PMID: 22918524 BACKGROUND

• Cicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26.

  PMID: 30926291 BACKGROUND

• Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410.

  PMID: 31617564 BACKGROUND

• Merzenich MM, Van Vleet TM, Nahum M. Brain plasticity-based therapeutics. Front Hum Neurosci. 2014 Jun 27;8:385. doi: 10.3389/fnhum.2014.00385. eCollection 2014.

  PMID: 25018719 BACKGROUND

• Ng EM, Polatajko HJ, Marziali E, Hunt A, Dawson DR. Telerehabilitation for addressing executive dysfunction after traumatic brain injury. Brain Inj. 2013;27(5):548-64. doi: 10.3109/02699052.2013.766927. Epub 2013 Mar 8.

  PMID: 23472964 BACKGROUND

• Missiuna C, Mandich AD, Polatajko HJ, Malloy-Miller T. Cognitive orientation to daily occupational performance (CO-OP): part I--theoretical foundations. Phys Occup Ther Pediatr. 2001;20(2-3):69-81.

  PMID: 11345513 BACKGROUND

• Wolf TJ, Doherty M, Kallogjeri D, Coalson RS, Nicklaus J, Ma CX, Schlaggar BL, Piccirillo J. The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Oncology. 2016;91(3):143-52. doi: 10.1159/000447744. Epub 2016 Jul 23.

  PMID: 27449501 BACKGROUND

• Maeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y.

  PMID: 36746805 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yafit Gilboa, PhD

  Hebrew University of Jerusalem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will take place only after the investigator will complete baseline assessment, so the assessment procedure wont be affected by group allocation. In addition, the investigator who will assess the outcomes post intervention and at 3 month follow up will be blind to the intervention allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trail (RCT)

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 26, 2019
• Study Start: February 26, 2018
• Primary Completion: September 30, 2021
• Study Completion: August 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

IL (1)