Effect of psycho-educational intervention on hot flushes and related symptoms after treatment for localised breast cancer

• Conditions: Hot flushes in women with previous localised breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000186550
• Lead Sponsor: Supportive Care Research Group at the Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

Localised breast cancer (Stage I, II & III); Adjuvant therapy (surgery ± chemotherapy ± radiotherapy) completed for more than 3 months but no more than 5 years (may take tamoxifen or aromatase inhibitor but no modification allowed during the time of the study); Have HF (³ 5 / 24 hours).

Exclusion Criteria

Women taking pharmacological medications for HF; Women with severe depression who are currently seeing a psychiatrist or taking antidepressants for < 3 months; Women currently undergoing cognitive-behavioural therapy; Women cognitively impaired.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of hot flushes measured with a hot flushes diary where each hot flush and its severity will be recorded for 7 days at each timepoint.[Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after). ];Daily hot flush score (frequency x severity score for each HF) measured with a hot flushes diary where each hot flush and its severity will be recorded for 7 days at each timepoint.[Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after). ]

Secondary Outcome Measures

Name	Time	Method
Changes in interference of hot flushes with different aspects of life[Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).];Changes in sleep, fatigue, anxiety and mood disturbance[Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).]