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Trial registered on ANZCTR


Registration number
ACTRN12615000878572
Ethics application status
Approved
Date submitted
10/08/2015
Date registered
21/08/2015
Date last updated
21/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of the application of Self-Determination Theory to an online cognitive rehabilitation intervention in remediating cognitive dysfunction associated with cancer and its treatment.
Scientific title
Randomized controlled trial comparing a web-based version of the Responding to Cognitive Concerns (ReCog) cognitive-behavioural intervention to waitlist for subjective and objective cognitive functioning in cancer survivors.
Secondary ID [1] 287253 0
Nil
Universal Trial Number (UTN)
U1111-1173-0618
Trial acronym
Online ReCog RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive dysfunction associated with cancer and treatment. 295868 0
Condition category
Condition code
Cancer 296116 296116 0 0
Any cancer
Mental Health 296117 296117 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online version of "ReCog" was adapted from the face-to-face manualized intervention that is based on principles of cognitive behavioral therapy and cognitive rehabilitation. The online intervention is comprised of 4 modules that offer education, skills training and skills practice on topics such as memory, attention, fatigue, and emotions, as well as between-session homework. The intervention is designed to be completed on a laptop or desktop computer remotely (e.g., at home) via the internet. Each module takes approximately 60 minutes to complete, and should be completed in one sitting. Participants are expected to complete one module per week, and thus are given 4 weeks access to complete all 4 modules. Each module involves education and skills training (e.g. goal-setting, problem solving, relaxation training). Participants are then expected to practice these skills for homework each week by keeping record of their practice habits and their implementation of their learnt skills. This should take approximately 30-60 minutes per week. Treatment adherence is monitored through response submissions during completion of the online modules, and participant feedback about homework completion.
Intervention code [1] 292547 0
Rehabilitation
Intervention code [2] 292602 0
Treatment: Other
Intervention code [3] 292603 0
Behaviour
Comparator / control treatment
Waitlist control. Participants who are randomly assigned to the waitlist group are offered intervention after all assessments are completed (4.5 months after initial assessment). Waitlist participants are able to access standard medical and health treatments, with no specific restrictions other than not participating in the online ReCog intervention until after assessments are completed.
Control group
Active

Outcomes
Primary outcome [1] 295793 0
Subjective cognitive function assessed by the Functional Assessment of Cancer Therapy Cognitive Function 3 (FACT-Cog-3), and the Brief Assessment of Prospective Memory (BAPM).
Timepoint [1] 295793 0
Baseline, post-intervention (6 weeks after baseline) and follow-up (3 months after intervention completion).
Primary outcome [2] 295794 0
Objective cognitive function assessed by a series of 13 neuropsychological tests using the WebNeuro online program.
Timepoint [2] 295794 0
Baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention).
Secondary outcome [1] 316524 0
Distress assessed by the Kessler Psychological Distress scale (K10).
Timepoint [1] 316524 0
Baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).
Secondary outcome [2] 316525 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] 316525 0
Baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).
Secondary outcome [3] 316526 0
Illness perceptions, as assessed by the Brief Illness Perceptions Questionnaire.
Timepoint [3] 316526 0
Baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).
Secondary outcome [4] 316527 0
Perceptions of Autonomy, as measured by the Basic Psychological Needs Scale (BPNS).
Timepoint [4] 316527 0
Baseline, 3 weeks after baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).
Secondary outcome [5] 316718 0
Perceptions of Competence, as measured by the Basic Psychological Needs Scale (BPNS).
Timepoint [5] 316718 0
Baseline, 3 weeks after baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).
Secondary outcome [6] 316719 0
Perceptions of Relatedness, as measured by the Basic Psychological Needs Scale (BPNS).
Timepoint [6] 316719 0
Baseline, 3 weeks after baseline, post-intervention (6 weeks after baseline), and follow-up (3 months after intervention completion).

Eligibility
Key inclusion criteria
Adults aged 18 or more; experienced adult-onset cancer (excluding cancer known to have affected the central nervous system); completed all major treatments for cancer (e.g., surgery, chemotherapy, and radiotherapy) at least 6 months prior to data collection (but ongoing hormone treatments are acceptable);subjective complaints of cognitive impairment; access to a laptop/desktop computer with a mouse and reliable internet services.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer involving the central nervous system (primary or secondary tumors); previous treatment with cranial radiotherapy or intrathecal chemotherapy; current cancer diagnosis.

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)
Participants volunteer by contacting the research team. Sealed opaque envelopes will be prepared by a researcher who is not connected to the research project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table from a statistics book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Random allocation of cancer survivors to either immediate Intervention or Waitlist (delayed access to intervention).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size of a minimum 20 participants per group (40 total) is 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. The target sample size of 40 participants per group (80 total) was decided to account for anticipated drop out rates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291815 0
University
Name [1] 291815 0
Griffith University
Address [1] 291815 0
Gold Coast Campus, Griffith University
Parklands Drive
Southport, Qld 4222
Country [1] 291815 0
Australia
Funding source category [2] 291816 0
Charities/Societies/Foundations
Name [2] 291816 0
Cancer Council Queensland
Address [2] 291816 0
PO Box 201
Spring Hill, Qld 4004

553 Gregory Terrace
Fortitude Valley, Qld 4006
Country [2] 291816 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus, Griffith University
Parklands Drive
Southport, Qld 4222
Country
Australia
Secondary sponsor category [1] 290476 0
Charities/Societies/Foundations
Name [1] 290476 0
Cancer Council Queensland
Address [1] 290476 0
PO Box 201
Spring Hill, Qld 4004

553 Gregory Terrace
Fortitude Valley, Qld 4006
Country [1] 290476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293334 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293334 0
Griffith University
Gold Coast Campus
Parklands Drive
Southport, Qld 4222
Ethics committee country [1] 293334 0
Australia
Date submitted for ethics approval [1] 293334 0
07/01/2015
Approval date [1] 293334 0
18/03/2015
Ethics approval number [1] 293334 0
PSY/F4/14/HREC

Summary
Brief summary
The primary purpose of this study is to determine whether a web-based version of the ReCog program has a greater impact on cognitive function and other wellness measures than standard care in cancer survivors.

Who is it for?
You may be eligible to join this study if you are aged 18 or over, have experienced adult-onset cancer of any type other than a cancer affecting the central nervous system, have completed treatment at least 6 months ago (and not more than 5 years ago) and have complaints of cognitive function.

Study details:
On enrolling in this study, participants will be allocated to one of two groups. The first group will receive access to the ReCog online program. You will be required to complete 4 modules, each lasting approximately 60 minutes, plus weekly homework activities taking approximately 30-60 minutes each. Activities will include relaxation training, goal-setting, problem-solving and the learning of new strategies to improve areas of cognitive function, such as memory, fatigue, attention and emotions. Participants will have 4 weeks to complete the modules, and are expected to complete one module per week. The second group will have access to the ReCog program 4.5 months after group 1. All participants will be asked to fill out a series of questionnaires at four timepoints up to 3 months after the end of the intervention period.

It is hoped that the findings of this trial will establish the efficacy of the web-based ReCog program to aid cognitive function in cancer survivors.
Trial website
http://www.recogintervention.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59430 0
Ms Mary Mihuta
Address 59430 0
Griffith University, Gold Coast Campus
School of Applied Psychology
Parklands Drive
Southport, Qld 4222
Country 59430 0
Australia
Phone 59430 0
+61 (0) 435 040 507
Fax 59430 0
Email 59430 0
mary.mihuta@griffithuni.edu.au
Contact person for public queries
Name 59431 0
Dr Heather Green
Address 59431 0
Griffith University, Gold Coast Campus
School of Applied Psychology
Parklands Drive
Southport, Qld 4222
Country 59431 0
Australia
Phone 59431 0
+61 (07) 5678 9086
Fax 59431 0
Email 59431 0
h.green@griffith.edu.au
Contact person for scientific queries
Name 59432 0
Dr Heather Green
Address 59432 0
Griffith University, Gold Coast Campus
School of Applied Psychology
Parklands Drive
Southport, Qld 4222
Country 59432 0
Australia
Phone 59432 0
+61 (07) 5678 9086
Fax 59432 0
Email 59432 0
h.green@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results