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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672189
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Climacteric Symptoms Breast Cancer Survivors Behavioral: EVA-Online Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms
Study Start Date : February 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Waiting list control group
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.
Experimental: EVA-Online guided group

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.

Behavioral: EVA-Online
Internet-based cognitive behavioral therapy

Experimental: EVA-Online self-management group
The content of the self-management CBT/Relaxation program is the same as the guided version of the program as described above, but without weekly guidance by a trained therapist. The women allocated to the self-management intervention will work through the program independently.
Behavioral: EVA-Online
Internet-based cognitive behavioral therapy




Primary Outcome Measures :
  1. Change in overall levels of menopausal symptoms [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Overall levels of menopausal symptoms are assessed by using the FACT-ES

  2. Change in vasomotor symptoms [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Vasomotor symptoms are assessed with the Hot Flush Rating Scale (HFRS)


Secondary Outcome Measures :
  1. Change in overall levels of sexual functioning [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    The overall levels of sexual functioning are assessed with the Sexual Activity Questionnaire (SAQ)

  2. Change in psychological distress [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Psychological distress is assessed with the Hospital Anxiety and Depression Scale (HADS)

  3. Change in sleep quality [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Sleep quality is assessed with the Groningen Sleep Quality Scale (GSQS)

  4. Change in hot flush frequency [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Hot flush frequency is assessed with the frequency subscale of the Hot Flush Rating Scale (HFRS)

  5. Change in health related quality of life [ Time Frame: Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2) ]
    Health related quality of life is assessed with the SF-36 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672189


Locations
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Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Investigators
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Principal Investigator: Neil K. Aaronson, PhD The Netherlands Cancer Institute
Principal Investigator: Hester S.A. Oldenburg, PhD The Netherlands Cancer Institute
Principal Investigator: Marc Van Beurden, PhD The Netherlands Cancer Institute
Publications:
Cijfers over kanker, Nederlandse Kankerregistratie,beheerd door IKNL © januari 2014, 2014
Society. AC: Cancer Facts Figures - 2000. Atlanta, GA, 2003
Hunter MS: Cognitive behavioural interventions for premenstrual and menopausal problems. J Reprod Infant Psychol:183-193, 2003
Cohen J: Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey, Lawrence Earlbaum Associates, 1988
Diggle P, Heagerty P, Liang K, et al: Analysis of longitudinal data. New York, Oxford University Press, 2002

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02672189    
Other Study ID Numbers: NKI 2014-6788 / NL53182.031.15
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by The Netherlands Cancer Institute:
Climacteric symptoms
Menopause
Breast Cancer Survivors
Internet-based
Cognitive behavioral therapy
Psychosocial intervention
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases