| Literature DB >> 34589620 |
D B Raphael1,2,3, N S Russell3, B Winkens4, J M Immink5,6, P G Westhoff7, M C Stenfert Kroese8, M R Stam9, N Bijker10, C M J van Gestel11, T van der Weijden2, L J Boersma1.
Abstract
BACKGROUND ANDEntities:
Year: 2021 PMID: 34589620 PMCID: PMC8461042 DOI: 10.1016/j.tipsro.2021.08.002
Source DB: PubMed Journal: Tech Innov Patient Support Radiat Oncol ISSN: 2405-6324
Overview of the time schedule for data acquisition via patient questionnaires and via Case Report Forms (CRFs) filled out by clinicians. T1 is < 3 days after the decision, T2 is 3 months after the decision.
| Decisional Conflict Scale | x | x | |
| SDM-Q9 | x | ||
| CollaboRATE | x | ||
| Patient knowledge | x | ||
| Patient preferences | x | x | |
| Treatment chosen | x | ||
| CRF with disease and treatment characteristics, and consultation length | x | ||
Fig. 1Flow diagram with an overview of included patients per arm.
Patient characteristics per study-arm.
| Intervention | Control | |||
|---|---|---|---|---|
| Mean Age (in years) | 60.4 ( | 62.8 ( | 0.050 | |
| Indication for SDM on (additional) RT yes or no: | DCIS | 62 (33%) | 64 (30%) | 0.824 |
| Educational level | Low | 50 (28%) | 86 (42%) | 0.007 |
| SDM indicated in MDT | No | 62 (34%) | 90 (44%) | 0.044 |
| Axillary treatment | Sentinel node procedure | 109 (58%) | 137 (65%) | 0.694* |
| Systemic therapy | Yes | 53 (28%) | 67 (31%) | 0.458 |
| Breast surgery | Breast-conserving surgery | 167 (89%) | 191 (89%) | 0.833* |
| cTNM | T0 | 66 (35%) | 75 (36%) | 0.601* |
| pTNM | T0 | 86 (46%) | 86 (41%) | 0.098 |
| Histology | DCIS | 62 (33%) | 68 (32%) | 0.684 |
| Bloom-Richardson tumor grade | 1 | 61 (34%) | 72 (35%) | 0.923 |
| Receptor status | ER - | 83 (44%) | 87 (41%) | 0.515 |
*Fisher’s exact test.
MDT = multi-disciplinary team, RT = radiotherapy, MARI = MARI method (marking of the axilla with radioactive iodine seeds).
Results of primary and secondary outcome measures. Raw data are summarized with absolute scores and numbers. The p-values represent the results of the linear and logistic mixed model analyses, corrected for age and educational level. T1 is < 3 days after the decision, T2 is 3 months after the decision.
| Outcome measure | Intervention | Control | Corrected difference between intervention and control (95% CI)* |
|---|---|---|---|
| T2 DCS (0–100) | 27.3 (12.9) | 26.8 (11.4) | 0.85 (-1.67, 3.36) |
| T1 DCS (0–100) | 27.3 (12.9) | 26.2 (12.4) | 1.10 (-1.52, 3.72) |
| T1 Knowledge (-11–11) | 7.4 (2.5) | 6.1 (2.7) | 1.00 (0.50, 1.49) |
| T1 CollaboRATE (0–100) | 88.6 (14.4) | 88.9 (15.8) | −0.16 (-3.32, 2.99) |
| T1 SDMQ9 (0–100) | 74.0 (19.7) | 72.2 (22.4) | 1.81 (-2.56, 6.18) |
| Consultation length (min) | 41.7 (13.5) | 40.8 (14.3) | 1.52 (-1.21, 4.25) |
| Number of consultations | 2.22 (7.2) | 2.01 (6.78) | 0.02 (-0.20, 0.24) |
| Intervention | Control | OR (95 %CI) | |
| More (additional) treatment chosen (%) | 44.52 | 55.7 | 0.59 (0.37, 0.95) |
*Corrected for age and educational level.
| Patients with low-risk ductal carcinoma in situ (DCIS) after breast-conserving surgery deciding on whole/partial breast RT or no RT (DCIS group). |
| Patients with low-risk invasive ductal carcinoma after breast-conserving surgery deciding on whole/partial breast RT or no RT (low-risk breast cancer group). |
| Patients with intermediate-risk breast cancer after mastectomy deciding on thoracic wall RT or no RT (chest wall irradiation group). |
| Patients with intermediate-risk breast cancer after breast-conserving surgery deciding on whole breast RT with or without an extra boost dose to the tumor bed (boost/no-boost group). |
| You received a lot of information about the advantages and disadvantages of choosing for radiotherapy or to leave radiotherapy out of your treatment. Here you see some questions about this subject. Please answer the questions with the knowledge you have, do not look up the right answers. | |||
|---|---|---|---|
| True | False | Don’t know | |
| The radiation treatment, including the time to get dressed and undressed, takes 30 min per day. | |||
| For the radiation treatment I have to go to the hospital on a daily basis, only on the weekdays. | |||
| I will feel pain during the radiation treatment procedure. | |||
| During the radiation treatment I will be radioactive and I will not be allowed to come close to children. | |||
| If the surgeon removed the tumor completely, radiation treatment is not necessary. | |||
| The shape and the sensitivity of my breast can change even years after the radiation treatment. | |||
| It is likely that I will feel nauseous as a consequence of the radiation treatment. | |||
| The skin reaction can worsen after the radiation treatment before it gets better. | |||
| Due to the radiation treatment, my breast might stay painful in the long term. | |||
| Due to the radiation treatment, I might feel tired for some weeks. | |||
| These are statements about the decision to undergo radiotherapy or to leave radiotherapy out of your treatment. We would like to ask you to read these statements and to thing about the decision you made. Please indicate whether you agree or disagree with this quote. This way, you indicate which attributes were important to you when making the decision. | ||||
|---|---|---|---|---|
| T1 | T2 | |||
| Control (%) | Intervention (%) | Control (%) | Intervention (%) | |
| 1. I think the idea of radiation is really awful | ||||
| 2. I’ll do whatever it takes to reduce the chances of tumor recurring | ||||
| 3. I’m put off by the idea of daily radiation treatment/extra days of radiotherapy (boost) | ||||
| 4. I’m put off by the radiation side effects | ||||
| 5. The cosmetic result in the long term is important to me | ||||
| 6. Choosing for radiotherapy/extra radiotherapy (boost) gives me peace of mind | ||||
| 7. What my health care provider advises is important to make a decision | ||||
| 8. I feel a responsibility towards those close to me to choose radiotherapy/extra radiotherapy (boost) | ||||
| 9. Reasons other than those mentioned above were the most important to me in making my decision | ||||
| T1 | ||||
|---|---|---|---|---|
| Question | Control (%) | Order* | Intervention (%) | Order* |
| 1. I think the idea of radiation is really awful | 36 (6) | 7 | 25 (5) | 7/8 |
| 2. I’ll do whatever it takes to reduce the chances of tumor recurring | 138 (23) | 1 | 94 (19) | 2 |
| 3. I’m put off by the idea of daily radiation treatment/extra days of radiotherapy (boost) | 28 (5) | 8 | 16 (3) | 9 |
| 4. I’m put off by the radiation side effects | 71 (12) | 4 | 74 (15) | 3 |
| 5. The cosmetic result in the long term is important to me | 24 (4) | 9 | 25 (5) | 7/8 |
| 6. Choosing for radiotherapy/extra radiotherapy (boost) gives me peace of mind | 81 (14) | 3 | 69 (14) | 4 |
| 7. What my health care provider advises is important to make a decision | 124 (21) | 2 | 102 (21) | 1 |
| 8. I feel a responsibility towards those close to me to choose radiotherapy/extra radiotherapy (boost) | 45 (8) | 5 | 34 (7) | 6 |
| 9. Reasons other than those mentioned above were the most important to me in making my decision | 44 (7) | 6 | 47 (10) | 5 |
| Total | 591 | 486 | ||
| T2 | ||||
| Control (%) | Order* | Intervention (%) | Order* | |
| 1. I think the idea of radiation is really awful | 26 (5) | 8 | 32 (7) | 6 |
| 2. I’ll do whatever it takes to reduce the chances of tumor recurring | 132 (24) | 1 | 100 (20) | 1 |
| 3. I’m put off by the idea of daily radiation treatment/extra days of radiotherapy (boost) | 30 (5) | 7 | 20 (4) | 8 |
| 4. I’m put off by the radiation side effects | 58 (10) | 4 | 72 (15) | 3 |
| 5. The cosmetic result in the long term is important to me | 14 (2) | 9 | 19 (4) | 9 |
| 6. Choosing for radiotherapy/extra radiotherapy (boost) gives me peace of mind | 92 (16) | 3 | 71 (14) | 4 |
| 7. What my health care provider advises is important to make a decision | 117 (21) | 2 | 97 (20) | 2 |
| 8. I feel a responsibility towards those close to me to choose radiotherapy/extra radiotherapy (boost) | 45 (8) | 6 | 31 (6) | 7 |
| 9. Reasons other than those mentioned above were the most important to me in making my decision | 47 (8) | 5 | 50 (10) | 5 |
| Total | 561 | 492 | ||