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

Effect of psycho-educational intervention on hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) after treatment for localised breast cancer - Pilot study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000186550

Enrollment

Registered

2006-05-17

Start date

2006-07-15

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

Brief summary

Hot flushes are frequent and bothersome to many women previously diagnosed with breast cancer. Fatigue, insomnia, anxiety and mood problems are often related to hot flushes. According to the literature a psycho-educational intervention seems to be a promising treatment for hot flushes but has not been rigorously studied in women with previous breast cancer. The primary purpose of the study will be changes in frequency of hot flushes and daily hot flush score (frequency x severity score for each HF). Hypothesis: A psycho-educational intervention utilising information provision, cognitive behavioural strategies and relaxation training will improve hot flushes, fatigue, insomnia, anxiety and mood disturbance in women with previous breast cancer. The psycho-educational intervention will involve four weekly group sessions during which information about hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) will be given. We will also give strategies to improve and manage these symptoms according to some cognitive-behavioural strategies. In addition relaxation techniques will be taught to try to reduce the frequency/severity of hot flushes.

Interventions

Pilot pre-test/post-test design; psycho-educational intervention utilising evidence-based information provision, cognitive-behavioural strategies and relaxation training with four weekly group sessions (duration of the intervention: 4 weeks). Each group session will last 90 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results