Clinical trial · Interventional
Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms
A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms
NCT02672189CI-TRIAL-00040413completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Climacteric Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EVA-Online | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Waiting list control group
- description
- Women in the waiting list control group will receive usual care. They will complete questionnaires during a period of 6 months. After completion of the last questionnaire they will be offered the opportunity to follow the EVA-Online program.
- type
- EXPERIMENTAL
- label
- EVA-Online guided group
- description
- The CBT/Relaxation program (EVA-Online) consists of 6 online sessions intended to be completed weekly over a 6 week period. The program 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). Throughout the program women will be asked to spend an hour a week to read the session and fill in the assignments and to spend 30 minutes per day on homework exercises (eg, filling in a hot flush/night sweats diary, practicing relaxation techniques). Participating women will first undergo a 30 minute phone interview with a trained therapist before they start the online program. The same therapist will provide weekly feedback and support.
- interventionNames
- Behavioral: EVA-Online
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Age limit: stated age concerns age at time of diagnosis. Inclusion Criteria: * Female * Diagnosis of histologically confirmed primary breast cancer * 50 years or younger at time of diagnosis * Premenopausal at time of diagnosis * Treatment induced menopause due to at least one of the following treatment regimens: 1) chemotherapy (\< 5 years \> 4 months); 2) hormonal therapy (\<5 years; may currently receive hormonal treatment); oophorectomy (\< 5 years \> 4 months) * Disease free at time of study entry * Presence of menopausal symptoms Exclusion Criteria: * Lacks basic proficiency in Dutch * No access to the internet * Serious cognitive or psychiatric problems * Participation in concurrent studies and/or therapy programs to alleviate menopausal symptoms
References
Publications (33)
- BACKGROUNDCijfers over kanker, Nederlandse Kankerregistratie,beheerd door IKNL © januari 2014, 2014
- BACKGROUNDSociety. AC: Cancer Facts Figures - 2000. Atlanta, GA, 2003
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- BACKGROUNDCouzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737. PMID 7595732
- BACKGROUNDBiglia N, Cozzarella M, Cacciari F, Ponzone R, Roagna R, Maggiorotto F, Sismondi P. Menopause after breast cancer: a survey on breast cancer survivors. Maturitas. 2003 May 30;45(1):29-38. doi: 10.1016/s0378-5122(03)00087-2. PMID 12753941
- BACKGROUNDRosenberg SM, Partridge AH. Premature menopause in young breast cancer: effects on quality of life and treatment interventions. J Thorac Dis. 2013 Jun;5 Suppl 1(Suppl 1):S55-61. doi: 10.3978/j.issn.2072-1439.2013.06.20.