Quality of life (QOL) assessment in the care of individual cancer patients

ISRCTN	ISRCTN77737914
DOI	https://doi.org/10.1186/ISRCTN77737914
Protocol serial number	1460
Sponsor	University of Leeds (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 16/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Lyndsay Campbell
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Quality of life (QOL) assessment in the care of individual cancer patients: a randomised interventional trial
Study acronym	ATT (Attention Control Study)
Study objectives	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(s)	Leeds East Research Ethics Committee approved on the 09/03/2004 (ref: 04/008)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key 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
Key exclusion criteria	Does not meet the exclusion criteria
Date of first enrolment	01/03/2004
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Psychosocial and Clinical Practice Research Group

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes