1. Menopausal symptoms
Conditions
Interventions
Group A: CBT and relaxation. The CBT and relaxation training will consist of 6 weekly group sessions (with 8-10 participants per group) of approximately 1.5 hours duration. It will also include ¡®home
(3) relaxation and stress reduction
(4) cognitive restructuring of unhelpful thoughts, elicited by group discussion
and (5) encouraging helpful behavioral strategies (e.g., pacing activities). The primary focus of the CBT will be on hot flushes and night sweats, but other symptoms (e.g., vaginal dryness), sexuality
sessions 1-6), a nurse practitioner (part of session 1), and a psychologist/sexologist (part of sessions 5 and 6). Training of the health care providers will be provided on-site by Dr. Hunter.
Grou
Sponsors
KWF Kanker Bestrijding
(Dutch Cancer Society)
Postbus 75508
1070 AM Amsterdam
020-5700500
info@kwfkankerbestrijding.nl
Eligibility
Inclusion criteria
Inclusion criteria: Women can be included if they are younger than 50 years of age, with histologically confirmed primary breast cancer (stages: T1 ¨C T4, N0 ¨C N1 and M0). All women will have been premenopausal at the time of diagnosis, have completed adjuvant chemotherapy (with the exception of herceptin, which can continue to receive) a minimum of 4 months and a maximum of 5 years prior to study entry. Women may currently be receiving adjuvant hormonal therapy. All women should be disease-free at time of study entry. Potentially eligible women will be screened for the presence of at least one of the following 3 menopausal symptoms during the previous 2-month period: hot flushes, sweating and/or vaginal dryness.
Exclusion criteria
Exclusion criteria: Women will be excluded from the study if they lack basic proficiency in Dutch, if they have serious cognitive or psychiatric problems, or serious physical comorbidity that would preclude them from participating in a physical exercise program. Since physical exercise may be contraindicated as a treatment for hot flushes in obese women, 49 patients with a BMI ¡Ý 30 will be excluded from the study. Patients participating in concurrent studies or rehabilitation programs containing psychosocial interventions will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Menopausal symptoms; 2. vasomotor symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary symptoms; 2. Sexuality; 3. Body- and self image; 4. Quality of life; 5. Psychological distress. | — |
Contacts
Public ContactSaskia Duijts
NKI-AVL, afdeling PSOE Plesmanlaan 121
Outcome results
None listed