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Cognitive DeclineCRCINCT04210778

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

A study testing Cognitive orientation to daily occupational performance (CO-OP) and Computerized Cognitive Training (BrainHQ, posit science) in people with Cognitive Decline and Cancer, run by Hadassah Medical Organization at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Decline, Cancer
What is being tested?
Cognitive orientation to daily occupational performance (CO-OP) and Computerized Cognitive Training (BrainHQ, posit science)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteIsrael
Study dates
26 Feb 2018to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah Medical Organization

    Jerusalem

Other trials in Israel

About this study

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.

Being tested
Cognitive orientation to daily occupational performance (CO-OP), Computerized Cognitive Training (BrainHQ, posit science)
Keywords
Cancer related cognitive impairment, Telerehabilitation, Computerized Cognitive training, Adult cancer survivors, Functional treatment
Medical subject headings
Cognitive Dysfunction, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive orientation to daily occupational performance (CO-OP)Behavioural

    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.

  • Computerized Cognitive Training (BrainHQ, posit science)Behavioural

    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)

Study groups in NCT04210778
Study groupRoleWhat they receive
CRAFT (Cognitive Training and Functional Treatment)ExperimentalOver 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
Receives: Behavioral: Cognitive orientation to daily occupational performance (CO-OP); Behavioral: Computerized Cognitive Training (BrainHQ, posit science)
Computerized Cognitive TrainingActive comparatorThis group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training
Receives: Behavioral: Computerized Cognitive Training (BrainHQ, posit science)
Treatment As UsualNo interventionThis group will receive no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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.

    Measured: 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)

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

    A patient reported quality of life questionnaire commonly used in cancer survivors. The tool consists of 21-statements on which the respondent is asked to think of the last week and determine his level of agreement to each statement on a 5-point scale (0=not at all, 4= very strongly agree), higher scores indicate greater QOL.

    Measured: 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)

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

    A self-report measure for the screening and severity of depressive symptomatology. The nine items in the questionnaire regard the frequency of symptoms within the last 2 weeks and are rated on a four-point Likert scale (0= not at all, 3=almost every day). The maximum score is 27, with higher scores reflecting more depressive symptoms.

    Measured: 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)

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

    A self-report measure used for the screening and severity of GAD, It includes 7 items describing the severity of the patient's anxiety over the past 2 weeks on a four- point Likert scale (0= not at all sure, 3= nearly every day). The sum score ranges from 0 to 21, with values of 5, 10, 15 indicated mild, moderate or severe anxiety symptoms

    Measured: 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)

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

    A self-report questionnaire used to assess rumination among adults. The RRS includes 22 items describing responses to depressed mood. Items are rated on a 4-point Likert scale (1= almost never, 4= almost always). A total score can be calculated, summing all 22 items scores (22-88), higher scores indicating more rumination.

    Measured: 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)

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

    A fatigue measure used to assess cancer patients at the active or survivor stage. The 13-item questionnaire utilizing a five-point Likert scale (0 = not at all, 4=very much so). The total score varies from 0 - 52, higher score indicating more fatigue

    Measured: 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)

  6. Change in the New General Self-Efficacy Scale (NGSE) (Chen, Gully, & Eden, 2001)

    A self administered questionnaire used to evaluate self-efficacy. The questionnaire includes eight items that are rated on a five- point Likert scale (1= strongly disagree, 5=strongly agree). The total score ranges from 9 to 40, with higher scores reflecting better self-efficacy.

    Measured: 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)

  7. Change in Performance Quality Rating Scale (PQRS) (Martini, Rios, Polatajko, Wolf, & McEwen, 2015)

    An observational measure, used to assess actual performance of client-selected activities. Score ranges between 1 (0% task completion) to 10 (100% of task completion) and is established by therapist thoroughly questioning client about performance using explicit questions.

    Measured: 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)

  8. Social Presence (Hauber, Regenbrecht, Billinghurst, & Cockburn, 2006)

    A questionnaire used to measure co-presence and social presence of adults participating in technology based social interactions

    Measured: 3 Time points during intervention (Week 1, Week 5, Week 10), CRAFT only

  9. Satisfaction questionnaire and interview

    A satisfaction questionnaire and interview were developed for the use of this study

    Measured: Time 1: At completion of intervention (an average of 15 weeks after baseline) (CRAFT only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start26 Feb 2018
  3. Primary completion30 Sep 2021
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trail (RCT)
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210778
Sponsor's protocol ID
CRCI-HMO-CTIL
Acronym
CRCI
Status last verified
Mar 2023
First submitted
1 Dec 2019
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22918524

  • 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.

    PubMed 30926291

  • 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.

    PubMed 31617564

  • 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.

    PubMed 25018719

  • 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.

    PubMed 23472964

  • 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.

    PubMed 11345513

  • 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.

    PubMed 27449501

  • 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.

    PubMed 36746805

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive orientation to daily occupational performance (CO-OP) and Computerized Cognitive Training (BrainHQ, posit science) in people with Cognitive Decline and Cancer, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Canadian Occupational Performance Measure (COPM) (Law et al., 1998) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210778, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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