Cognitive Rehabilitation for Cancer Survivors with Perceived Cognitive Impairment
The University of Sydney
159 participants
May 28, 2014
Interventional
Conditions
Summary
This study aims to evaluate two cognitive rehabilitation programs in cancer survivors with perceived cognitive dysfunction after chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have had definitive surgery for invasive early cancer within the last 5 years and were treated with adjuvant chemotherapy. You should have completed at least 3 cycles of chemotherapy and be experiencing cognitive changes. Trial details Participants in this trial will be randomly (by chance) allocated to one of three groups. Participants in one group will undergo a structured neurocognitive learning programme (Attention Process Training [APT]) in small groups across 6 weeks for 2 hours per week. Participants in the second group will undergo a systematic teaching of strategies to compensate for the functional impact of cognitive deficit (Compensatory Strategy Training [CST]). Again, this rehabilitation program will be conducted in small 2 hour group sessions over a 6 week period. Participants in the third group will receive standard treatment. Participants will complete questionnaires and cognitive tests at baseline, 4 weeks, 6 months and 12 months post intervention in order to determine the efficacy of the two different cognitive rehabilitation programs.
Eligibility
Inclusion Criteria8
- Diagnosis of invasive solid tumour cancer for which definitive treatment was performed within the last 5 years
- Completed at least 3 cycles of chemotherapy
- Aged >17 years
- A “NO” response recorded for the Single Item Cognitive Impairment Question
- Speak fluent English and read to a year 8 standard.
- Give written informed consent.
- Chemotherapy, radiotherapy, immunotherapy (e.g. trastuzumab and/or lapatinib) received must have been completed at least 6 months prior to randomisation.
- Hormonal treatment (including tamoxifen or an aromatase inhibitor) is permitted as long as treatment has been commenced at least 4 weeks prior to randomisation and is not likely to be ceased within 6 months of randomisation.
Exclusion Criteria4
- , ECOG Performance Status of > 2
- , Any evidence of extra-nodal metastatic disease.
- , Any major pre-existing neurological condition, co-morbidity, psychiatric history or substance abuse that could interfere with their ability to perform cognitive testing.
- , Prior malignancy within the last 5 years (other than non-melanomatous skin cancer or cervical cancer in-situ) or previous chemotherapy other than adjuvant or neoadjuvant breast cancer treatment.
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Interventions
There are two active intervention arms and a watchful waiting control arm. Arm 1, A structured neurocognitive learning programme (Attention Process Training [APT –II], aimed at improving underlying cognitive deficit. This intervention focuses on restoring the specific cognitive function, attention. Arm 2, A systematic teaching of strategies to compensate for the functional impact of cognitive deficits (Compensatory Strategy Training [CST]).This treatment intervention helps patients adapt to the presence of deficits, rather than trying to treat the underlying deficit. Both active interventions consists of 2-hour small group sessions per week for 6 weeks, with a trained therapist.
Locations(1)
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ACTRN12612001041842