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NCT Number: NCT04210778

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

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.

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Key information

Conditions

Cognitive Decline Cancer Cognition Disorders Cognitive Dysfunction Mental Disorders Neoplasms Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

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)

Primary outcomes

  1. 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)

    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.

  2. Change in Computerized Cognitive Assessments (Posit Science)

    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)

    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

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

    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)

    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.

Secondary outcomes

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

    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)

    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.

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

    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)

    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.

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

    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)

    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

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

    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)

    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.

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

    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)

    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

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

    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)

    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.

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

    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)

    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.

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

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

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

  9. Satisfaction questionnaire and interview

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

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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Israel Cancer Association
  • Israel cancer research fund

Registry information

Acronym: CRCI

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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