Breast Neoplasms Clinical Trial
Official title:
Investigating the Impact of Tailored Reports on Anxiety
Verified date | August 2005 |
Source | University of Plymouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
Objective: To explore the hypothesis that different methods of selecting and printing
information for cancer patients could improve emotional support by affecting interaction
with others, and so lead to improved psychological wellbeing.
Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment
and three month follow-up.
Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who
they confide).
Interventions: Printed booklets.
1. Half had 'general' CancerBACUP information for that cancer; half had 'personal'
information from the medical record plus selected general information;
2. Half chose information by 'interacting' with the computer; half had a larger volume of
material in booklets that were produced 'automatically'.
3. Half had additional 'anxiety management advice'.
Outcomes: Patients' views; use of booklet with others; change in reported social support;
change in anxiety and depression.
Status | Completed |
Enrollment | 400 |
Est. completion date | July 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer Exclusion Criteria: - Receiving palliative care - Severe pain or symptoms causing distress - Having cancer at other sites - Having no spoken English - Receiving treatment for psychological or psychiatric problems - Visual or mental handicap - Having case notes not available or ambiguous or illegible. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | Beatson Oncology Centre | Glasgow |
Lead Sponsor | Collaborator |
---|---|
University of Plymouth |
United Kingdom,
Jones RB, Pearson J, Bental D, Cawsey A, Gilmour WH, Barrett A et al. The effect of tailored reports on the anxiety of cancer patients. Final Report to ESRC on grant number L328253024, February 2004. (Details available on the Economic and Social Research
Jones RB, Pearson J, Cawsey AJ, Bental D, Barrett A, White J, White CA, Gilmour WH. Effect of different forms of information produced for cancer patients on their use of the information, social support, and anxiety: randomised trial. BMJ. 2006 Apr 22;332( — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | patients' views three months after intervention | |||
Primary | use of booklet with others between intervention and three month follow up | |||
Primary | change in reported social support between recruitment and three month follow up | |||
Primary | change in anxiety and depression between recruitment and three month follow up | |||
Secondary | confidants' views three months after intervention | |||
Secondary | change in confidants' anxiety and depression between recruitment and three month follow up |
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