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

Hadassah Medical Center

Status: Completed

Conditions: Cognitive Decline; Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04210778

CRCI-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age ≥ 18;
2. 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.
3. interested in treatment and state they have 2 weekly hours available for the intervention.
4. 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.
5. 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);
6. Daily access to a computer and Internet facilities;
7. Able to sign an informed consent;
8. Stable psychiatric condition (according to participants self- report and medical file).

Exclusion criteria

1. no prior experience using computers;
2. pregnancy;
3. History of a central nervous system tumor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

CRAFT (Cognitive Training and Functional Treatment)

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive orientation to daily occupational performance (CO-OP)

Behavioral: Computerized Cognitive Training (BrainHQ, posit science)

Computerized Cognitive Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Computerized Cognitive Training (BrainHQ, posit science)

Treatment As Usual

No Intervention group

Description:

This group will receive no intervention