Evaluation of a brain training programme in cancer survivors self reporting cognitive changes

Not Applicable

Recruiting

• Conditions: Cognitive impairment in cancer survivors; Cancer - Breast; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12609000683235
• Lead Sponsor: Dr Janette Vardy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Diagnosis of a primary malignancy for which definitive treatment was performed.
2. Completed a minimum of 3 cycles of potentially curative chemotherapy within the last 6-60 months.
3. Aged 18 years and above.
4. Self reported changes in memory and concentration as per the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire –C30 Cognitive Functioning scale (EORTC-CF)
5. Speak fluent English and read to a year 8 standard.
6. Give written informed consent.
7. Radiotherapy and/or immunotherapy (e.g. trastuzumab, lapatinib, bevacizumab or cetuximab) (if received) must have been completed at least 12 weeks prior to randomisation.
8. Hormonal treatment (including tamoxifen or an aromatase inhibitor) is permitted providing treatment has been commenced at least 4 weeks prior to randomisation. Change of hormonal therapy should not be anticipated within the next 6 months, nor should it be likely to be ceased within 6 months.
9. Easy access to computer and internet facilities.
10. Participants are expected to be able to complete the study and be available for follow up.

Exclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of > 2.
2. Any evidence of locally recurrent or metastatic disease.
3. Any active psychiatric diagnosis or history of a cognitive disorder. Psychotropic medications are permitted if the patient is established on a stable regime and dosing schedule.
4. Pre-existing neurological condition or any other co-morbidity, which would interfere with their ability to perform cognitive testing.
5. Prior malignancy within the last 5 years (other than non-melanomatous skin cancer, cervical cancer in-situ and the cancer of interest for which they received their chemotherapy).
6. Any previous chemotherapy other than that given for the cancer of interest.

Study & Design

• Study Type: Interventional
• Study Design: Not specified