NCT00127465

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
Last Updated

December 11, 2008

Status Verified

August 1, 2005

First QC Date

August 4, 2005

Last Update Submit

December 10, 2008

Conditions

Breast NeoplasmsProstatic NeoplasmsLaryngeal NeoplasmsCervix Neoplasms

Keywords

Medical InformaticsPatient educationSocial supportCancerAnxiety

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • confidants' views three months after intervention

  • change in confidants' anxiety and depression between recruitment and three month follow up

Interventions

Issue of information bookletPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatson Oncology Centre

Glasgow, Glasgow, G11 6NT, United Kingdom

Location

Related Publications (2)

  • 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)

    RESULT

  • 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. doi: 10.1136/bmj.38807.571042.68. Epub 2006 Apr 5.

    PMID: 16597660RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsLaryngeal NeoplasmsUterine Cervical NeoplasmsNeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMental Disorders

Study Officials

  • Ray Jones, PhD

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 5, 2005

Study Start

November 1, 2001

Study Completion

July 1, 2003

Last Updated

December 11, 2008

Record last verified: 2005-08

Locations

GB(1)