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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127465
First Posted: August 5, 2005
Last Update Posted: December 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Plymouth
  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
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Investigating the Impact of Tailored Reports on Anxiety

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
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 Council website www.esrcsocietytoday.ac.uk)

ClinicalTrials.gov Identifier: NCT00127465     History of Changes
Other Study ID Numbers: ESRC-L328253025
First Submitted: August 4, 2005
First Posted: August 5, 2005
Last Update Posted: December 11, 2008
Last Verified: August 2005

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

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