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

NCT04210778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-03-14

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive orientation to daily occupational performance (CO-OP)

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.

BEHAVIORAL

Computerized Cognitive Training (BrainHQ, posit science)

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)

Sponsors & Collaborators

  • Israel cancer research fund

    collaborator UNKNOWN
  • Israel Cancer Association

    collaborator OTHER
  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Yafit Gilboa, PhD · Hebrew University of Jerusalem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2021-09-30
Completion
2022-08-30

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210778 on ClinicalTrials.gov