Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial (EVA project)

December 19, 2007 updated by: The Netherlands Cancer Institute

Background: Breast cancer is the most common form of cancer among women in the Netherlands. Approximately 11,000 women are diagnosed with breast cancer annually, of whom about 30% are below 50 years of age. 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. The symptoms resulting from accelerated estrogen withdrawal can be pronounced and severe, and may adversely affect women's sexual functioning, body image, and overall HRQL. 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. For these women, non-hormonal medications are frequently prescribed to treat vasomotor symptoms. Although these medications have been shown to yield moderate symptom relief, they also have a number of bothersome side effects. To alleviate urogenital symptoms, local vaginal moisturizing or estrogen cream is often prescribed. There is growing evidence that cognitive behavioral therapy (CBT) including relaxation techniques, and physical exercise may effectively reduce vasomotor symptoms in naturally occurring menopause. CBT and relaxation techniques are aimed primarily at the modification of precipitants of hot flushes and at stress management. Physical exercise on a regular basis affects neurotransmitters, which regulate central thermoregulation.

Purpose: 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.

Plan of investigation: This multicenter study will employ a prospective, full-factorial design. In total, 325 consenting women will be randomized to group A, group B, group AB or a usual care, 'waiting list' control group (N = 81-81 per group). 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. The program will begin with a structured assessment of the target symptoms: hot flushes, night sweating and vaginal dryness. The overriding goal of the intervention is to provide symptomatic women with information skills and support to manage their symptoms more effectively. 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 per 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. Women allocated to the intervention groups will be asked to complete a battery of questionnaires assessing menopausal symptoms (the primary outcome), sexuality, body- and self-image, psychological distress and generic HRQL prior to the start of the program (baseline, T0), at 12 weeks (T1) and at 6 months follow-up (T2). Women allocated to the control group will complete the same questionnaire battery at parallel points in time.

Results/ relevance: If demonstrated to be effective, the availability of a structured supportive intervention program (modules A, B or AB) will be a welcome addition to regular medical care offered to breast cancer patients with treatment-induced menopause. It is anticipated that such a program will have direct benefit in terms of symptoms relief and the improvement of patients' HRQL.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

325

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 (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:

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 ≥ 30 will be excluded from the study. Patients participating in concurrent studies or rehabilitation programs containing psychosocial interventions will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 4
Control group
Other: Control group
Waiting list control group
Experimental: 1
CBT and relaxation.
Behavioral: CBT and relaxation
Group A: CBT and relaxation.
Experimental: 2
Physical activity
Behavioral: Physical activity
Group B: Physical exercise program.
Experimental: 3
CBT and physical activity
Behavioral: CBT and physical activity
Group AB: Combined CBT and exercise program. Women assigned to Group AB will undergo the CBT and exercise elements of the program concurrently. To as great an extent as possible, the on-site CBT and in-clinic exercise training sessions will be scheduled on the same day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Menopausal symptoms
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Vasomotor symptoms; urinary symptoms; sexuality; body- and self image; psychological distress; quality of life
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Neil Aaronson, Prof, NKI-AvL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKI 2006-3470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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