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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-01-07-L.M.vanVliet-V1-36 | Other Identifier | Dutch Cancer Institute (AVL) and Leiden University |
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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
| The Netherlands Cancer Institute | OTHER |
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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)
NA, the investigators cannot yet reveal the manipulation as it would influence the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| video 1 | Experimental | The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
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| video 2 | Experimental | The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
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| video 3 | Experimental | the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
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| video 4 | Experimental | the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communciation intervention | Behavioral | The investigators cannot reveal the manipulated communication as this might influence participant outcomes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| socio-demographics | measuring the change in age, SES, education age, SES, education (7 questions) | Day 0 (day before chemo 1) |
| information needs | coping infromation needs ( 2 questions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liesbeth van vliet | Leiden University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek | Amsterdam | North Holland | 1066CX | Netherlands |
When giving consent participations are informed that i) for storage, analysis, publication, and archiving only coded research data will be used ii) and that the coded research data might be used for further or future analysis. Anonymized data might be shared on an Open Science platform.
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| ID | Term |
|---|---|
| D003142 | Communication |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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A single-centre proof-of-principle RCT will be conducted using a scripted video-design. Four different information-videos about chemotherapy's side effects are created in which specific communication is manipulated to assess their effect on patient (psychological/cognitive/physical outcomes. (The investigators cannot yet reveal the manipulation as it would influence our participants)
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| Day 0 (day before chemo 1) |
| anxiety | measuring the change in anxiety trait (20 questions) and current anxiety (1 question) | 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). |
| side effects (expected and experienced) | 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 | 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 |
| psychological outcomes | measuring the change in psychological outcomes communication satisfaction, trust, self-efficacy, distress (4 questions) | 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 |
| medical outcomes | use of co-medication (1 question) | day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |