The proposed study will evaluate the efficacy of a supportive intervention program in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of life of younger women (< 50 years) with breast cancer who have become…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Menopausal symptoms
- Vasomotor symptoms
Secondary outcome
- Urinary symptoms
- Sexuality
- Body image & self-image
- Psychological distress
- Generic health-related quality of life
Background summary
Premenopausal women with breast cancer treated with chemotherapy or hormonal
therapy may experience a premature onset of the menopause. Estrogen deficiency
following adjuvant treatments leads to primary endocrine symptoms, including
vasomotor and urogenital problems. Secondary symptoms include insomnia due to
night sweats, dyspareunia due to vaginal dryness, weight gain, and
psychological distress. Healthy women who enter natural menopause are often
prescribed hormone replacement therapy (HRT) to alleviate vasomotor and sexual
symptoms. However, due to possible tumor-promoting effects, HRT is
contraindicated for patients with a history of breast cancer. In this study,
the effectiveness of two supportive interventies will be assessed, i.e.
cognitive behavioral therapy and physical exercise.
Study objective
The proposed study will evaluate the efficacy of a supportive intervention
program in alleviating menopausal symptoms, improving sexual functioning and
enhancing the quality of life of younger women (< 50 years) with breast cancer
who have become prematurely menopausal as a result of their treatment.
Specifically, the study will evaluate CBT including relaxation (A), physical
exercise (B), and a combination of A and B.
Study design
For this multicentre trial, patients will be recruited from about 15 hospitals
in the Amsterdam region, and they will be randomly allocated to group A, B, AB
or the control group (N=81-82 per group) (2x2 factorial design). Upon
completion of the study, the patients assigned to the control group will be
given the opportunity to undergo either the A or B intervention program.
Women in the intervention groups and the control group will be asked to
complete a battery of questionnaires prior to randomization (T0), at 12 weeks
(T1) and at 6 months (T2) post-entry study. Main outcome measures are
menopausal symptoms, vasomotor symptoms, urinary symptoms, sexuality, body
image and self-image, psychological distress, generic health-related quality of
life.
Intervention
The program will begin with a structured assessment of the target symptoms: hot
flushes, night sweating and vaginal dryness. For group A, the intervention will
consist of 6 weekly group CBT sessions of 1.5 hours, of 15 minutes of daily
homework and a booster session at 3 months. The CBT will focus on understanding
and self-control of menopausal symptoms. Relaxation techniques (paced
respiration and muscle relaxation) will focus on the reduction of sympathetic
nervous system activity, and are expected to have a positive impact on the
frequency and intensity of hot flushes.
For group B, the intervention will be an individually tailored, 12 week
home-based physical exercise program (of 2.5-3 hours a week), with instructions
provided in-clinic on 2 occasions, and telephone support on 2 additional,
interim occasions. The physical exercise program is intended to enhance fitness
levels, in general, and to improve thermoregulation specifically related to hot
flushes.
Group AB will receive both the CBT and exercise program elements.
Study burden and risks
Potential disadvantage is that participation in the study will be quite an
effort.
Plesmanlaan 121
1066 CX
NL
Plesmanlaan 121
1066 CX
NL
Listed location countries
Age
Inclusion criteria
The study sample will be composed of 325 women, younger than 50 years of age, with histologically confirmed primary breast cancer (stages: T1 - T4, N0 - N1 and M0). All women will have been premenopausal at the time of diagnosis, have completed adjuvant chemotherapy or hormonal therapy a minimum of 4 months and a maximum of 5 years prior to study entry, and will currently be disease-free. 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
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, patients with a BMI >= 30 will be excluded from the study. Patients participating in concurrent studies or rehabilitation programs containing psychosocial interventions will also be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19935.031.07 |