Investigating the Impact of Tailored Reports on Anxiety Amongst Cancer Patients and Their Confidants - Full Text View

Sponsored by:	University of Plymouth
Information provided by:	University of Plymouth
ClinicalTrials.gov Identifier:	NCT00127465

Purpose

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.

Half had 'general' CancerBACUP information for that cancer; half had 'personal' information from the medical record plus selected general information;
Half chose information by 'interacting' with the computer; half had a larger volume of material in booklets that were produced 'automatically'.
Half had additional 'anxiety management advice'.

Outcomes: Patients' views; use of booklet with others; change in reported social support; change in anxiety and depression.

Condition	Intervention	Phase
Breast Neoplasms Prostatic Neoplasms Laryngeal Neoplasms Cervix Neoplasms	Procedure: Issue of information booklet	Phase I Phase II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Investigating the Impact of Tailored Reports on Anxiety

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anxiety Breast Cancer Cancer Cervical Cancer Depression Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Plymouth:

Primary Outcome Measures:

patients' views three months after intervention
use of booklet with others between intervention and three month follow up
change in reported social support between recruitment and three month follow up
change in anxiety and depression between recruitment and three month follow up

Secondary Outcome Measures:

confidants' views three months after intervention
change in confidants' anxiety and depression between recruitment and three month follow up

Estimated Enrollment:	400
Study Start Date:	November 2001
Estimated Study Completion Date:	July 2003

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127465

Locations

United Kingdom
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT

Sponsors and Collaborators

University of Plymouth

Investigators

Principal Investigator:

Ray Jones, PhD

University of Plymouth

More Information

Additional Information:

People at the Centre of Communication and Information Technology (ESRC programme within which this study was funded) This link exits the ClinicalTrials.gov site

Funding body with details of protocol and final report available This link exits the ClinicalTrials.gov site

Publications:

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(7547):942-8. Epub 2006 Apr 5.

Study ID Numbers:	ESRC-L328253025
Study First Received:	August 4, 2005
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00127465 History of Changes
Health Authority:	United Kingdom: National Health Service

Keywords provided by University of Plymouth:

Medical Informatics
Patient education
Social support
Cancer
Anxiety

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Laryngeal Carcinoma
Genital Neoplasms, Female
Breast Neoplasms
Uterine Diseases
Laryngeal Neoplasms
Urogenital Neoplasms

Genital Diseases, Male
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Uterine Neoplasms
Laryngeal Diseases
Prostatic Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Uterine Diseases
Laryngeal Neoplasms
Urogenital Neoplasms
Genital Diseases, Male

Genital Diseases, Female
Uterine Cervical Neoplasms
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Respiratory Tract Diseases
Head and Neck Neoplasms
Uterine Neoplasms
Laryngeal Diseases
Prostatic Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009