Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02672189
• Date of registration: 26/01/2016
• Prospective Registration: No
• Primary sponsor: The Netherlands Cancer Institute
• Public title: Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms
• Scientific title: A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms
• Date of first enrolment: February 2015
• Target sample size: 254
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02672189
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Hester S.A. Oldenburg, PhD
• Affiliation: The Netherlands Cancer Institute

• Name: Marc Van Beurden, PhD
• Affiliation: The Netherlands Cancer Institute

• Name: Neil K. Aaronson, PhD
• Affiliation: The Netherlands Cancer Institute

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer Survivors

Climacteric Symptoms

Intervention(s)

Behavioral: EVA-Online

Primary Outcome(s)

Change in vasomotor symptoms [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Change in overall levels of menopausal symptoms [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Secondary Outcome(s)

Change in sleep quality [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Change in health related quality of life [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Change in hot flush frequency [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Change in overall levels of sexual functioning [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Change in psychological distress [Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)]

Secondary ID(s)

NKI 2014-6788 / NL53182.031.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dutch Cancer Society