UMIN-CTR Clinical Trial
| Recruitment status | Preinitiation |
| Unique ID issued by UMIN | UMIN000035817 |
| Receipt No. | R000040805 |
| Scientific Title | Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2020/08/19 (Ver. 4) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| Basic information | ||
| Public title | Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients | |
| Acronym | Communication on prognostic disclosure | |
| Scientific Title | Compassionate verbal and non-verbal communication skills on prognostic disclosure to cancer patients | |
| Scientific Title:Acronym | Communication on prognostic disclosure | |
| Region |
|
|
| Condition | ||
| Condition | Cancer | |
| Classification by specialty |
|
|
| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To explore if the addition of worst/bast cases on the median and typical range and/or hope/prepare statement can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure.
To explore if slow rather than rapid communication can convey compassion, decrease anxiety, and clinician trust on prognostic disclosure. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Explanatory |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Physician Compassionate Score |
| Key secondary outcomes | Six basic emotions
Anxiety Clinician trust |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Double blind -all involved are blinded |
| Control | Active |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 4 | |
| Purpose of intervention | Educational,Counseling,Training | |
| Type of intervention |
|
|
| Interventions/Control_1 | Verbal:
Best/Worst cases +/- |
|
| Interventions/Control_2 | Verbal:
Hope/Prepare statement +/- |
|
| Interventions/Control_3 | Non-verbal:
Neither Best/Worst nor Hope/Prepare statements: Slow/rapid |
|
| Interventions/Control_4 | Non-verbal:
Both Best/Worst and Hope/Prepare statements: Slow/rapid |
|
| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
|
|||
| Age-upper limit |
|
|||
| Gender | Male and Female | |||
| Key inclusion criteria | Outpatients of age 20 or older who are receiving care for cancer | |||
| Key exclusion criteria | Those who did not agree to participate | |||
| Target sample size | 300 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
|
||||||
| Organization | Seirei Mikatahara General Hospital | ||||||
| Division name | Department of Clinical Laboratory | ||||||
| Zip code | 433-8558 | ||||||
| Address | 3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN | ||||||
| TEL | 0534361251 | ||||||
| masanori.mori@sis.seirei.or.jp | |||||||
| Public contact | |||||||
| Name of contact person |
|
||||||
| Organization | Seirei Mikatahara General Hospital | ||||||
| Division name | Department of Clinical Laboratory | ||||||
| Zip code | 433-8558 | ||||||
| Address | 3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN | ||||||
| TEL | 0534361251 | ||||||
| Homepage URL | |||||||
| masanori.mori@sis.seirei.or.jp | |||||||
| Sponsor | |
| Institute | Seirei Mikatahara General Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Health, Labour, and Welfare Sciences Research Grant |
| Organization | |
| Division | |
| Category of Funding Organization | Japanese Governmental office |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Seirei Mikatahara General Hospital |
| Address | 3453 Mikataharacho, Kita-ku, Hamamatsu, JAPAN |
| Tel | 0534361251 |
| NA | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
|
||||||
| Related information | |
| URL releasing protocol | Not applicable |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | Not applicable | ||||||
| Number of participants that the trial has enrolled | 208 | ||||||
| Results | Unpublished |
||||||
| Results date posted |
|
||||||
| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Unpublished |
||||||
| Participant flow | Unpublished |
||||||
| Adverse events | Unpublished |
||||||
| Outcome measures | Unpublished |
||||||
| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Preinitiation | ||||||
| Date of protocol fixation |
|
||||||
| Date of IRB | |||||||
| Anticipated trial start date |
|
||||||
| Last follow-up date |
|
||||||
| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040805 |
