Breast Cancer, Communication, Quality of Life
Conditions
Keywords
scripted video-vignette study
Brief summary
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)
Detailed description
NA, the investigators cannot yet reveal the manipulation as it would influence the participants.
Interventions
BEHAVIORALCommunciation intervention
The investigators cannot reveal the manipulated communication as this might influence participant outcomes.
Sponsors
Dutch Cancer Society
The Netherlands Cancer Institute
Leiden University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| information needs | Day 0 (day before chemo 1) | coping infromation needs ( 2 questions) |
| anxiety | 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) |
| socio-demographics | Day 0 (day before chemo 1) | measuring the change in age, SES, education age, SES, education (7 questions) |
| psychological outcomes | 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) |
| medical outcomes | 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) |
| side effects (expected and experienced) | 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 |
Countries
Netherlands
Outcome results
None listed