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. 2019 Mar 25;2019(3):CD012387. doi: 10.1002/14651858.CD012387.pub2

Amstel 2017.

Methods RCT ‐ with intervention group (IG) and control group (CG)
Participants Patients treated with curative intent for breast cancer
Country: the Netherlands
Age: results not yet available, ≥ 18 years (inclusion criterion)
Sex: 100% female (inclusion criterion)
Inclusion criteria

  1. women with histology‐proven malignancy of the breast

  2. treatment with curative intent

  3. written and oral fluency in the Dutch language

  4. aged ≥ 18 years


Exclusion criteria

  1. men

  2. treated previously for a malignancy (except adequately treated cervix carcinoma in situ and basal cell carcinoma of the skin)

  3. women with psychiatric problems that would impair adherence to study


N randomised: based on power calculations, a total of 193 patients need to be included to have sufficient power for the primary and secondary outcomes
N in analysis: results not yet available
Interventions Content of screen:DISTRESS: tool = Distress Thermometer (DT): consists of a thermometer ranging from 0 (no distress) to 10 (extreme distress). In addition, the tool contains 47 questions (yes/no answers) related to different issues known as the Problem List (PL). The issues have been categorised into: practical issues, family/social issues, emotional issues, religious/spiritual issues, and physical issues. The DT concludes with the question: 'Would you like to talk with a professional about your problems?' (yes/no/maybe).
Interventionist: No interventionist for screening act (self‐reported measure).
Intervention procedure:SI with co‐intervention to use screening results: The participant will fill out the DT in the outpatient clinic a few minutes before the appointment, and a trained oncology nurse will discuss the DT results with the participant and ask if she desires a referral. The time allocated to these meetings will be between 5 and 30 minutes, depending on the severity of the distress and the nature of the problems. If the participant reports a DT score of < 5, the nurse will inquire as to whether the participant is sufficiently in control of her situation. The low distress score and the issues marked on the PL are discussed briefly. At a score ≥ 5 on the DT, an extensive exploratory conversation between the nurse and the participant will take place. The outcome of this conversation will be discussed in a psychosocial MDT
Conditions for implementation

  1. a system/person is needed to deliver and collect questionnaires and to control data management;

  2. a nurse to actively discuss the DT results with participants


Comparative condition: Usual care, without using the DT
Length of follow‐up: 2 years
Outcomes Primary outcomes

  1. QoL (the global QoL item of the EORTC QLQ‐C30)


Secondary outcomes

  1. functional and symptom scales of the EORTC QLQ‐C30 and BR23

  2. anxiety and depression (HADS)

  3. coping (Impact of Event Scale)

  4. illness cognition (Illness Cognition Questionnaire)

  5. distress (DT) (baseline and final measurement only)


Outcome time points: Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality, and during follow‐up, with a 3 and 6 month interval during the first and second year, respectively
Notes Information from conference abstracts and protocol paper available, no further data received from study authors since their results paper has not yet been accepted for publication
Registered as ‘Nurse Intervention Project (VIP)’ in ClinicalTrials.gov (NCT01091584)