PeNTAGOn: Peer & Nurse support Trial to Assist women in Gynaecological Oncology

Phase 3

Completed

• Conditions: Psychological distress in women who receive radiation therapy for Gynaecological Cancer; Psychosocial needs of women who receive radiation therapy for Gynaecological Cancer; Psychosexual difficulties that occur in women who receive Radiation therapy for Gynaecological Cancer; Symptom distress among women who receive Radiation therapy for Gynaecological Cancer; Quality of Life changes in women who receive Radiation therapy for Gynaecological Cancer; How prepared women are for Radiation therapy treatment for Gynaecological Cancer; Vaginal stenosis which occurs as a result of Radiation therapy for Gynaecological Cancer; Cancer - Other cancer types

• Registration Number: ACTRN12611000744954
• Lead Sponsor: Prof Penelope Schofield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 318

Inclusion Criteria

Eligible patients will:
1) Have a confirmed diagnosis of gynaecological cancer;
2) be scheduled to receive radiotherapy with curative intent to the pelvis,
3) be aged 18 years or older,
4) be able to read and write English, and give informed consent.

Exclusion Criteria

Exclusion criteria are:
1) a severe psychiatric or cognitive disorder,
2) treatment with palliative intent,
3) or previous treatment with radiotherapy to any part of the body.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Compared to the usual care group, the intervention group will report lower psychological distress.<br><br>Psychological distress will be assessed with the 14-item Hospital Anxiety and Depression Scale total scale (HADS-T) in a Questionnaire. Rasch analysis shows that items comprising the HADS-T form a unidimensional construct of psychological distress. It has demonstrated high internal consistency (alpha=0.82 to 0.90) in patient populations including cancer patients and responsiveness in psychosocial intervention studies.[From baseline to follow-up at a) pre-treatment and b) 4 weeks, 6 and 12 months post-treatment.]