Can nurse delivered cognitive behavioural therapy reduce the impact of hot flushes and night sweats in women who have had breast cancer?

Phase 3

Completed

• Conditions: Cancer; Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast; Breast cancer

• Registration Number: ISRCTN12824632
• Lead Sponsor: niversity of Southampton

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29739384 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32458473/ (added 20/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Study Completion: 2019-01-03
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Randomised controlled trial:
1. Women with primary breast cancer or DCIS
2. Women who have completed primary surgery radiotherapy and chemotherapy (may still be receiving adjuvant endocrine therapy or Herceptin)
3. Aged 16 years and over
4. Experiencing seven or more problematic HFNS/week, with an overall problem rating score of 4/10 or more
5. Ability and willingness to attend group sessions
6. Written informed consent

Process evaluation:
1. BCNs delivering the intervention (2 from each centre)
2. Purposively selected participants from the intervention arm who have consented to be interviewed (2 from each centre)
3. Managers and medical staff from participating centres, who are responsible for breast care services (1 manager and 1 member of the medical team from each centre)

Exclusion Criteria

Randomised controlled trial:
1. Benign breast disease
2. Metastatic disease
3. Current use of other therapies to help with HFNS, e.g. acupuncture, hypnosis and mindfulness

Process evaluation:
Participants who have not indicated that they are happy to be interviewed on the Consent Form.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Randomised Controlled Trial:<br> Impact of hot flushes and night sweats is measured using the Hot Flush and Night Sweats (HFNS) Problem Rating (1–10) at baseline and 26 weeks<br><br> Process Evaluation:<br> Acceptability of intervention is assessed through participant interviews, fidelity ratings of recordings of the intervention, an unvalidated questionnaire and session attendance figures at study end.<br>