Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000009516
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
8/01/2015
Date last updated
22/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanisms of an education intervention to remediate cognitive dysfunction associated with cancer and its treatment
Scientific title
Randomised controlled trial comparing the Responding to Cognitive Concerns (ReCog) cognitive-behavioural intervention to waitlist for subjective and objective cognitive function in cancer survivors
Secondary ID [1] 285648 0
Nil known
Universal Trial Number (UTN)
U1111-1164-0136
Trial acronym
ReCog RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-related cognitive dysfunction 293492 0
Condition category
Condition code
Cancer 293769 293769 0 0
Any cancer
Mental Health 294095 294095 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"ReCog" is a four-week manualised intervention based on principles of cognitive behavioural therapy and cognitive rehabilitation. It comprises 4 two-hour sessions involving education, skills training and skills practice on topics such as memory and attention, and between-session homework. The intervention is delivered in weekly group sessions of 3-10 participants with 2 facilitators. Homework takes approximately 30-60 minutes per week. Treatment adherence is monitored via session attendance and homework completion
Intervention code [1] 290589 0
Rehabilitation
Comparator / control treatment
1. Waitlist group. These participants are offered the intervention after all assessments are completed (4.5 months after the initial assessment). Waitlist participants are able to access standard medical and health treatments, with no specific restrictions other than not participating in the ReCog intervention until after assessments are completed. 2. Healthy volunteers with similar age and education to cancer survivors participate as a further comparison group; they participate in assessments only and do not receive any treatment or training
Control group
Active

Outcomes
Primary outcome [1] 293566 0
Subjective cognitive function, as assessed by the Functional Assessment of Cancer Therapy Cognitive Function 3 (FACT-Cog-3) and the Brief Assessment of Prospective Memory
Timepoint [1] 293566 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)
Primary outcome [2] 293567 0
Objective cognitive function, as assessed by the Repeatable Battery for Assessment of Neuropsychological Status (RBANS) and the Trailmaking Test
Timepoint [2] 293567 0
Baseline, Post-intervention (6 weeks after baseline), and Follow-up (3 months after intervention)
Secondary outcome [1] 311378 0
Distress, as assessed by the Kessler Psychological Distress scale (K10)
Timepoint [1] 311378 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)
Secondary outcome [2] 312081 0
Quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire version 3 (EORTC-QLQ-C30)
Timepoint [2] 312081 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)
Secondary outcome [3] 312084 0
Illness perceptions, as assessed by the Brief Illness Perceptions Questionnaire
Timepoint [3] 312084 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)
Secondary outcome [4] 312086 0
Cognitive Self-Efficacy, as assessed by the Cognitive Self-Efficacy Scale
Timepoint [4] 312086 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)
Secondary outcome [5] 312088 0
Benefit finding, as assessed by the Benefit Finding Scale
Timepoint [5] 312088 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion)

Eligibility
Key inclusion criteria
18 years or more; experienced adult-onset cancer (excluding cancer known to have affected the central nervous system); completed all major treatments for cancer (such as surgery, chemotherapy, and radiotherapy) at least 6 months prior to data collection (but ongoing hormone treatments were acceptable, e.g. oestrogen modifiers or androgen-suppressing medications); subjective cognitive impairment as shown by a score of <100 on the EORTC-QLQ-C30 cognitive function subscale. Healthy volunteers were required to be 18 years or over and have never been diagnosed with cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer known to involve the central nervous system (primary or secondary tumours). Previous treatment with cranial radiotherapy or intrathecal chemotherapy.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes prepared by a researcher who is unconnected to the research project
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistics book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Random allocation of cancer survivors to either immediate Intervention or Waitlist (delayed access to intervention). There was an additional Parallel group of healthy volunteers who had never experienced cancer.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of a minimum 20 participants per group was planned based on previous data showing effect sizes in the approximate range Cohen's d=0.5 to d=1.0. This would provide power of more than 80% at alpha level = .05, for detecting a Group x Time interaction. Analysis plan: Group x Time repeated measures ANOVAs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
3/04/2012
Date of last participant enrolment
Anticipated
3/09/2012
Actual
24/09/2012
Date of last data collection
Anticipated
Actual
7/03/2013
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290233 0
University
Name [1] 290233 0
Griffith University
Country [1] 290233 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus, Griffith University
Southport Qld 4222
Country
Australia
Secondary sponsor category [1] 288941 0
None
Name [1] 288941 0
Address [1] 288941 0
Country [1] 288941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291937 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291937 0
Ethics committee country [1] 291937 0
Australia
Date submitted for ethics approval [1] 291937 0
14/02/2012
Approval date [1] 291937 0
09/03/2012
Ethics approval number [1] 291937 0
PSY/16/12/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52714 0
Dr Summer King
Address 52714 0
C/- School of Applied Psychology
Gold Coast Campus, Griffith University
Parklands Drive, Southport Qld 4222
Country 52714 0
Australia
Phone 52714 0
+61,(0)7,56789086
Fax 52714 0
Email 52714 0
[email protected]
Contact person for public queries
Name 52715 0
Heather Green
Address 52715 0
School of Applied Psychology
Gold Coast Campus, Griffith University
Parklands Drive, Southport Qld 4222
Country 52715 0
Australia
Phone 52715 0
+61,(0)7,56789086
Fax 52715 0
Email 52715 0
[email protected]
Contact person for scientific queries
Name 52716 0
Heather Green
Address 52716 0
School of Applied Psychology
Gold Coast Campus, Griffith University
Parklands Drive, Southport Qld 4222
Country 52716 0
Australia
Phone 52716 0
+61,(0)7,56789086
Fax 52716 0
Email 52716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.