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

NCT02672189 | Completed Phase 3

• 1 other identifier: NKI 2014-6788 / NL53182.031.15
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Climacteric Symptoms; Breast Cancer Survivors

Keywords

Climacteric symptoms; Menopause; Breast Cancer Survivors; Internet-based; Cognitive behavioral therapy; Psychosocial intervention

Outcome Measures

Primary Outcomes (2)

• Change in overall levels of menopausal symptoms

  Overall levels of menopausal symptoms are assessed by using the FACT-ES

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

• Change in vasomotor symptoms

  Vasomotor symptoms are assessed with the Hot Flush Rating Scale (HFRS)

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

Secondary Outcomes (5)

• Change in overall levels of sexual functioning

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

• Change in psychological distress

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

• Change in sleep quality

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

• Change in hot flush frequency

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

• Change in health related quality of life

  Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)

Study Arms (3)

Waiting list control group

NO INTERVENTION

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.

EVA-Online guided group

EXPERIMENTAL

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

EVA-Online self-management group

EXPERIMENTAL

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

Interventions

EVA-Online BEHAVIORAL

Internet-based cognitive behavioral therapy

EVA-Online guided group; EVA-Online self-management group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Diagnosis of histologically confirmed primary breast cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

Related Publications (33)

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Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

NL (1)