Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
16/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Lyndsay Campbell

ORCID ID

Contact details

Psychosocial and Clinical Practice Research Group
St. James’s Institute of Oncology
Level 3
Bexley Wing
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1460

Study information

Scientific title

Quality of life (QOL) assessment in the care of individual cancer patients: a randomised interventional trial

Acronym

ATT (Attention Control Study)

Study hypothesis

To test the hypothesis that regular completion of quality of life (QOL) questionnaire, without feeding back results to oncologists, can help patients to explain their problems and can result in improved well being. The secondary aim of the study is to obtain a pure control and attention-control group for future studies, in which the oncologists will have the QOL information and can potentially influence the measured outcomes.

Ethics approval

Leeds East Research Ethics Committee approved on the 09/03/2004 (ref: 04/008)

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All

Intervention

After the baseline visit, patients in the intervention group will be asked to complete the EORTC QLQ-C30 and HADS on a touch-screen (TS) computer while waiting to see a doctor. This will be done over 3 consecutive visits. The results will be printed and filed, but not given to their oncologists. The control group will receive their usual medical care. All consultations will be audio-taped and subjected to content analysis.

Follow up length: 6 months
Study entry: single randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

1. Content of communication, measured at baseline and for a further three visits
2. Functional Assessment of Cancer Therapy General Scale (FACT-G), measured at baseline and at the end of the study

Secondary outcome measures

1. Other process measures (symptomatic drugs, tests, referrals), collected at baseline and for the next three visits
2. Patient-related outcomes (continuity of care and patient satisfaction), collected at baseline and at the end of the study
3. Descriptive information on patient views and attitudes regarding regular QOL data collection, collected at the end of the study

Overall trial start date

01/03/2004

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed or relapsed patients with cancer starting chemotherapy or multimodality treatment
2. Expected to attend the clinic at least 3times after the initial baseline visit;
3. Able and willing to give informed consent
4. Not taking part in other QL studies run by the Unit
5. Able to read and understand English
6. Not exhibiting overt psychopathology or serious cognitive dysfunction which would impede their being able to take part in the study
7. Either sex, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 220

Participant exclusion criteria

Does not meet the exclusion criteria

Recruitment start date

01/03/2004

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychosocial and Clinical Practice Research Group
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Faculty of Medicine and Health
Leeds
LS2 9JT
United Kingdom
-
FMHRO@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes