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Investigating the Impact of Tailored Reports on Anxiety Amongst Cancer Patients and Their Confidants

This study has been completed.
Sponsor:
Information provided by:
University of Plymouth
ClinicalTrials.gov Identifier:
NCT00127465
First received: August 4, 2005
Last updated: December 10, 2008
Last verified: August 2005
History of Changes
  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.

  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.


Condition Intervention Phase
Breast Neoplasms
Prostatic Neoplasms
Laryngeal Neoplasms
Cervix Neoplasms
 Procedure: Issue of information booklet
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Investigating the Impact of Tailored Reports on Anxiety

Resource links provided by NLM:

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
  Show Detailed Description

  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:

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

Keywords provided by University of Plymouth:
Medical Informatics
Patient education
Social support
Cancer
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Neoplasms
Uterine Cervical Neoplasms
Laryngeal Neoplasms
Prostatic Neoplasms
Mental Disorders
Neoplasms by Site
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013