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Completed

NCT Number: NCT05390723

Communication in Breast Cancer Care

The investigators will create 4 information-video's about chemotherapy side-effects in curative breast cancer care. The communication is manipulated in the four videos. Participants will watch the video before the first chemotherapy and complete questionnaires before and after viewing the video and after chemotherapy 1,2 and 4. (The investigators cannot yet reveal the manipulation as it would influence the participants)

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Key information

Conditions

Communication Behavior Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

About this study

NA, the investigators cannot yet reveal the manipulation as it would influence the participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (>18 years old) female breast cancer patients
  • Chemo-naïve patients
  • Scheduled in for curative neo-adjuvant chemotherapy: Four courses of AC chemotherapy (all combinations of AC + other chemotherapy courses are eligible)
  • Cognitively able to fill out an online questionnaire
  • Having internet access
  • Sufficient command of the Dutch language
  • pre-chemo no previous treatment or pre-chemo breast-conserving surgery and radiotherapy (WLE patients)

Exclusion criteria

  • NA

Treatment and study plan

Communciation intervention

Behavioral

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

Primary outcomes

  1. Anxiety

    Time frame: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

    measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)

Secondary outcomes

  1. socio-demographics

    Time frame: Day 0 (day before chemo 1)

    measuring the change in age, SES, education age, SES, education (7 questions)

  2. information needs

    Time frame: Day 0 (day before chemo 1)

    coping infromation needs ( 2 questions)

  3. anxiety

    Time frame: trait: Day 0 (day before chemo 1), current: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and dday 52-54 (10 days after chemo 4).

    measuring the change in anxiety trait (20 questions) and current anxiety (1 question)

  4. side effects (expected and experienced)

    Time frame: expected: Day 0 (day before chemo 1); experienced: day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

    measuring the change in side effects side effects (expected) (31 questions): probability, intensity, coping, and compliance intention side effects (experienced)(21 questions): intensity, number, coping, compliance intention

  5. psychological outcomes

    Time frame: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

    measuring the change in psychological outcomes communication satisfaction, trust, self-efficacy, distress (4 questions)

  6. medical outcomes

    Time frame: day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

    use of co-medication (1 question)

Sponsors and collaborators

Lead sponsor

Leiden University

Other

Collaborators

  • Dutch Cancer Society
  • The Netherlands Cancer Institute

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 25, 2022
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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