Specialty: Cancer, Primary sub-specialty: Breast Cancer
Conditions
Interventions
Randomised Controlled Trial:
Women will be randomly allocated 1:1 to one of two groups.
Investigative treatment (Group CBT) only:
Patients allocated to
Sponsors
University of Southampton
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomised Controlled Trial: 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 Process Evaluation: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact of hot flushes and night sweats is measured using the Hot Flush and Night Sweats (HFNS) Problem Rating (1–10) at baseline and 9 weeks 2. Sleep quality is measured using the Pittsburgh Sleep Quality Index at baseline, 9 and 26 weeks 3. Impact of hot flushes on daily activities and overall quality of life is measured using the Hot flash related daily interference scale at baseline, 9 and 26 weeks 4. Anxiety is measured using the Generalised Anxiety Disorder Questionnaire at baseline, 9 and 26 weeks 5. Depression is measured using the Patient Health Questionnaire at baseline, 9 and 26 weeks 6. Health-related quality of life is measured using the FACT B + ES at baseline,9 and 26 weeks 7. Hot flush beliefs and behaviours is measured using the Hot Flush Beliefs and Behaviour Scale (Short Form) at baseline, 9 and 26 weeks 8. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6, 9 and 26 weeks | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactEmma Kirkpatrick
Outcome results
None listed