Clinical trial NCT04210778: Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment
Official title: Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Cancer
Keywords: Cancer related cognitive impairment
Telerehabilitation
Computerized Cognitive training
Adult cancer survivors
Functional treatment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Israel cancer research fund
name: Israel Cancer Association
First posted: 2019-12-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trail (RCT)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Canadian Occupational Performance Measure (COPM) (Law et al., 1998)
timeFrame: 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)
measure: Change in Computerized Cognitive Assessments (Posit Science)
timeFrame: 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)
measure: Change in Functional Assessment of Cancer Therapy - Cognition (FACT COG) (Jacobs, Jacobsen, Booth-Jones, Wagner, & Anasetti, 2007)
timeFrame: 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:
measure: Change in the Functional Assessment of Cancer Therapy-General practice (FACT-GP) (Cella et al., 1993)
timeFrame: 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)
measure: Change in the Patient Health Questionnaire (PHQ-9)(Kroenke, Spitzer, & Williams, 2001)
timeFrame: 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)
measure: Change in the Generalized Anxiety Disorder (GAD -7) (Spitzer, Kroenke, Williams, & Löwe, 2006)
timeFrame: 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)
measure: Change in the Ruminative Response Scale (RRS) (Treynor, Gonzalez, & Nolen-Hoeksema, 2003)
timeFrame: 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)
measure: Change in the Functional Assessment of Cancer Therapy - Fatigue (FACT -F) (Yellen, Cella, Webster, Blendowski, & Kaplan, 1997)
timeFrame: 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)
measure: Change in the New General Self-Efficacy Scale (NGSE) (Chen, Gully, & Eden, 2001)
timeFrame: 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)
measure: Change in Performance Quality Rating Scale (PQRS) (Martini, Rios, Polatajko, Wolf, & McEwen, 2015)
timeFrame: 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)
measure: Social Presence (Hauber, Regenbrecht, Billinghurst, & Cockburn, 2006)
timeFrame: 3 Time points during intervention (Week 1, Week 5, Week 10), CRAFT only
measure: Satisfaction questionnaire and interview
timeFrame: Time 1: At completion of intervention (an average of 15 weeks after baseline) (CRAFT only)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hebrew University of Jerusalem
name: Yafit Gilboa, PhD
role: PRINCIPAL_INVESTIGATOR
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