The current study will evaluate systematically the efficacy and cost-effectiveness of two internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the severity of menopausal symptoms and improving copings skills with…
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Health condition
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Intervention
Outcome measures
Primary outcome
The primary outcomes are menopausal complaints, as assessed with a menopausal
complaints questionnaire called FACT-ES, and hot flushes and night sweats as
assessed by the Hot Flushes Rating Scale (HFRS).
Secondary outcome
The secondary study outcomes are sexuality problems (SAQ); sleep quality
(GSQS); psychological distress (HADS) and health related quality of life (MOS
SF- 36).
Background summary
Breast cancer is the most common cancer among women in the Netherlands, with
approximately 14.000 new cases reported in 2011. Nearly 30% of all women with
breast cancer are premenopausal at the time of diagnosis. Premature menopause
is a major concern of younger women undergoing (adjuvant/preventive) therapy
for cancer. Menopausal symptoms include hot flushes, night sweats, decreased
libido, insomnia due to night sweats, weight gain and psychological distress
amongst others. Among menopausal symptoms, hot flushes are considered to be the
most disruptive, with prevalence rates between 63% and 80% in breast cancer
patients.
Currently, there are medical treatment for menopausal symptoms. However, these
might be contra indicated in breast cancer patients or have bothersome side
effects. Effective and safe treatment options for these symptoms in breast
cancer patients are needed. A CBT intervention has been found to be beneficial
in the alleviation of menopausal symptoms in women with breast cancer, but
compliance with face-to-face CBT programs can be problematic. A promising
approach is to make this form of CBT more accessible and feasible for
participants by having it available via the internet. Although the efficacy of
CBT for this patient population has been demonstrated in the form of
face-to-face group therapy, its efficacy has not been investigated in a
randomized controlled trial when delivered via an internet platform in an
individual setting. If demonstrated to be efficacious and cost-effective, the
availability of such structured supportive intervention programs will be a
welcome addition to standard medical treatment offered to cancer patients with
treatment-induced menopause.
Hypotheses:
1. Women in the guided intervention group will report a significantly greater
reduction from baseline to 10 week and 6 month follow-up in menopausal symptoms
than patients in a usual care, waiting list control group, as assessed by the
FACT-ES Scale and/or the Hot Flush Rating Scale.
2. Women in the self-management intervention group will report a significantly
greater reduction from baseline to 10 week and 6 month follow-up in menopausal
symptoms than patients in a usual care, waiting list control group, as assessed
by the FACT-ES Scale and/or the Hot Flush Rating Scale.
3. Women in the guided intervention group will report significantly greater
improvement in sexual functioning, sleep quality, hot flash frequency,
psychological distress, and HRQOL than those in the control group.
4. Women in the self-management intervention group will report significantly
greater improvement in sexual functioning, sleep quality, hot flash frequency,
psychological distress, and HRQOL than those in the control group.
Study objective
The current study will evaluate systematically the efficacy and
cost-effectiveness of two internet-based CBT/relaxation programs (one guided,
the other self-managed) in reducing the severity of menopausal symptoms and
improving copings skills with regard to hot flushes and night sweats as well as
improving sexual functioning, improving quality of sleep, reducing emotional
distress and improving quality of life in younger breast cancer patients who
experience treatment-induced menopause.
Study design
For this trial patients will be recruited from several hospitals in the
Amsterdam region. Participants will be randomly allocated to either the guided
intervention group, the self-management group or the control group (N = 83 per
group). Upon completion of the study, the patients assigned to the control
group will be given the opportunity to undergo the internet-based cognitive
behavioral therapy program.
Women in the two intervention and control group will be asked to complete a
battery of questionnaires prior to randomization (T0), at 10 weeks (T1) and at
6 months (T2). Main outcome measures are vasomotor symptoms, menopausal beliefs
and behavior, sexual functioning, sleep quality, hot flash frequency,
psychological distress, and health related quality of life.
Intervention
The CBT and relaxation training will consist of 6 weekly sessions that also
include *homework* assignments (e.g., keeping a daily diary to monitor symptoms
and their precipitants). It comprises the following elements: (1) information
and advice about symptoms (e.g., hot flushes, night sweats and sexual
functioning); (2) monitoring and modifying precipitants; (3) relaxation and
stress reduction; (4) cognitive restructuring of unhelpful thoughts and (5)
encouraging helpful behavioral strategies (e.g., pacing activities. The primary
focus of the CBT is on hot flushes and night sweats, but other symptoms (e.g.,
vaginal dryness), sexuality, mood disturbance, and weight gain are also
addressed. A relaxation/paced breathing mp3 file will be provided for
practicing relaxation. The women allocated to the self-management intervention
will work through the program independently. The women in the guided
intervention will undergo a 30 minute phone interview with a trained therapist
(medical social worker or psychologist) before the start of the program. The
same therapist will provide support and weekly feedback by email during the
course of the program. The therapist will have access to the participants*
homework assignments and daily hot flush diary. Participants can also contact
the social worker by email in case they have any questions.
Study burden and risks
A potential disadvantage of participation in the study is the investment of
time and the effort it takes to complete the program.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
The study sample will be composed of 248 women, younger than 50 years of age at time of breast cancer diagnoses or PBSO, with histologically confirmed primary breast cancer (stages: T1 - T4, N0 - N3 and M0). All women will have been premenopausal at the time of diagnosis, and will have experienced a treatment-induced menopause due to (neo)adjuvant chemotherapy, hormonal therapy or or oophorectomy. Women may currently be receiving adjuvant hormonal therapy. In case of treatment-induced menopause due to adjuvant chemotherapy (with the exception of herceptin), treatment should have been completed a minimum of 4 months and a maximum of 5 years prior to study entry. For women who receive neo-adjuvant chemo, we will use 4 month post-surgery or post-radiation therapy as the minimal time since treatment. Oophorectomy should have been completed no more than 5 years prior to study entry. All women should be disease-free at time of study entry. Potential eligible women will be screened for the presence of menopausal symptoms.
Potentially eligible women will be screened for the presence of problematic hot flushes or night sweats during the past 2 months. Moreover, in the last week they should have experienced at least 10 hot flushes or night sweats during the past week and these hot flushes/night sweats should have been experienced as problematic (as indicated by an average score of two or higher on three items of the HFRS).
Exclusion criteria
Women will be excluded from the study if they lack basic proficiency in Dutch, if they have serious cognitive or psychiatric problems that would preclude them from following the intervention or completing the study questionnaires, or if they have no internet access. Patients participating in concurrent studies or rehabilitation programs to alleviate their menopausal problems 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 | NL53182.031.15 |