NCT03900806

Brief Summary

Many of the occupationally active cancer survivors experience cognitive problems.Both from an individual and a societal perspective, it is important to sustain cancer survivors' employability.The aim of the current study is to develop an internet-based cognitive intervention programme for occupationally active cancer survivors confronted with cognitive problems, and to evaluate the (cost-)effectiveness of this program. A three-armed randomized controlled trial will be conducted with six months of follow-up, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. Primary and secondary outcomes will be measured at baseline (T0), at three months, upon completion of the intervention (T1), and at three months post-intervention (T2).In total, 261 cancer survivors (18 - 65 years) who have returned to work and who experience cognitive problems will be recruited.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 3, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

March 26, 2019

Last Update Submit

April 29, 2022

Conditions

Cognitive Problems

Keywords

Cancer, Cognitive rehabilitation, eHealth

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Goal Attainment Scaling (GAS) at 3 and 6 months follow-up.

    Individually defined work-related treatment goals will be measured using the 6-point Goal Attainment Scale (GAS) on personal outcome (-3, achievement of the goal after training is worse; -2, achievement of the goal is the same; 1, partial achievement of the goal; 0, achievement of the goal; 1, exceeding the goal, and 2, greatly exceeding the goal). Patients will formulate three treatment goals at baseline, in collaboration with their cognitive therapist. Attainment of the goals is measured in a standardized way, i.e., an overall GAS T-score will be computed for each participant on basis of aggregated GAS scores involving attainment of multiple personal treatment goals, according a summary scoring algorithm that calculates the extent to which patients' goals are met.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

Secondary Outcomes (11)

  • Change from baseline Cognitive problems (CSC-W DV) at 3 and 6 months follow-up.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

  • Change from baseline Work ability (WAI) at 3 and 6 months follow-up.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

  • Change from baseline Work functioning (WRFQ) at 3 and 6 months follow-up.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

  • Change from baseline Need for recovery after a work day (VBBA) at 3 and 6 months follow-up.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

  • Change in Health-Related Quality of Life (SF-36) at 3 and 6 months follow-up.

    T0 (baseline), T1 (12 weeks), T2 (26 weeks)

  • +6 more secondary outcomes

Study Arms (3)

Basic Cognitive Rehabilitation

EXPERIMENTAL

The basic arm will consist of a brief cognitive training programme without individual guidance throughout the intervention, involving three to five sessions (each approximately 60 minutes in duration), which have to be completed in a period of 12 weeks.

Behavioral: online cognitive rehabilitation

Extensive Cognitive Rehabilitation

EXPERIMENTAL

The extensive arm will consist of a comprehensive training program, involving five to eight sessions (each approximately 60 minutes in duration), which have to be completed in a period of 12 weeks. After the first session, each further session in the extensive group involves tailored therapy guidance . Cognitive strategy modules will be assigned by the therapist depending on the participants' cognitive profile and personal treatment goals.

Behavioral: online cognitive rehabilitation

Waitlist control group

NO INTERVENTION

Participants in the waiting list control group will be offered the opportunity to follow the basic cognitive rehabilitation program after completion of the 26-week follow-up measurement.

Interventions

online cognitive rehabilitationBEHAVIORAL

The cognitive rehabilitation program will be based on the protocol of a frequently used meta-cognitive strategy approach applied in many rehabilitation centers in the Netherlands. The program consists of several modules that can be used in a flexible way, depending on the specific individual problems and goals. Therapists have undergone additional training in issues related to cancer-related cognitive impairment and problems occupationally active cancer survivors might experience at work. In both intervention arms, participants will receive access to a secured personal webpage, where all content relevant to the treatment sessions can be obtained.

Basic Cognitive RehabilitationExtensive Cognitive Rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working age (18 - 65 years) at the time of study entry
  • Histologically confirmed cancer (all tumour types except for brain tumours).
  • Completed primary therapy including chemotherapy, targeted agents and/or immunotherapy 6 months ago. Patients who are still receiving hormonal therapy can be included in the trial.
  • Experience cancer/cancer treatment-related cognitive problems. Both patients with and without cognitive impairment assessed with neuropsychological tests, formally assessed with neuropsychological tests, will be included in the study.
  • Fixed or temporary employment contract (with at least six months left of their contract).
  • Being at work for a minimum of 12 working hours/week.

You may not qualify if:

  • Psychiatric or neurological disorder that can interfere with current study aims.
  • Lack basic proficiency in Dutch.
  • Participating in comparable studies or programmes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

Related Publications (3)

  • Klaver KM, Duijts SFA, Geusgens CAV, Kieffer JM, Agelink van Rentergem J, Hendriks MP, Nuver J, Marsman HA, Poppema BJ, Oostergo T, Doeksen A, Aarts MJB, Ponds RWHM, van der Beek AJ, Schagen SB. Internet-based cognitive rehabilitation for working cancer survivors: results of a multicenter randomized controlled trial. JNCI Cancer Spectr. 2024 Jan 4;8(1):pkad110. doi: 10.1093/jncics/pkad110.

    PMID: 38273712DERIVED

  • Klaver KM, Duijts SFA, Geusgens CAV, Aarts MJB, Ponds RWHM, van der Beek AJ, Schagen SB. Neuropsychological test performance and self-reported cognitive functioning associated with work-related outcomes in occupationally active cancer survivors with cognitive complaints. J Cancer Surviv. 2024 Apr;18(2):412-424. doi: 10.1007/s11764-022-01223-x. Epub 2022 Jul 1.

    PMID: 35776235DERIVED

  • Klaver KM, Duijts SFA, Geusgens CAV, Aarts MJB, Ponds RWHM, van der Beek AJ, Schagen SB. Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial. Trials. 2020 Jul 20;21(1):664. doi: 10.1186/s13063-020-04570-1.

    PMID: 32690067DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sanne B. Schagen, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kete M. Klaver, MSc

CONTACT

0031205126053k.klaver@nki.nl

Sanne B. Schagen, PhD

CONTACT

0031205122328s.schagen@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding of participants and professionals is not possible for this type of intervention. Blinding for assessment is not applicable since measurements are computer-based.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A multicenter, three-armed randomized controlled trial will be conducted to evaluate the effectiveness of an online cognitive rehabilitation program. Two intervention groups (i.e., an extensive and a basic cognitive rehabilitation program) and one waitlist control group will be included. An economic evaluation will be conducted to assess cost-effectiveness of the cognitive rehabilitation program.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 3, 2019

Study Start

August 3, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)