A randomised phase III trial evaluating the efficacy of more intensive written information in patients having radical radiation therapy.

A prospective randomised phase III trial evaluating the effect of more intensive information on patient satisfaction and anxiety.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000705684

Acronym

P.S.S.

Enrollment

212

Registered

2005-11-02

Start date

2004-06-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The intervention is intensive written information and an extra nursing consultation.The written information outlines radiotherapy details and toxicity.Lifestyle issues such as diet,exercise,smoking and pratical issues such as parking and treatment costs.The control arm has a standard consultation.The intervention/control is for the duration of radiation treatment varying from 5-7 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

The patient must be having radical radiotherapy.The patient must have a good understanding of english.The patient must be able to complete questionnaire unaided.Used only for patients diagnosed with Breast,Lung,Prostate,Rectal and Gynaecological cancer.

Exclusion criteria

A poor understanding of written english.Significant visual impairment and previous radiation therapy.

Outcome results