|- candidate number||11234|
|- NTR Number||NTR3354|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-feb-2012|
|- Secondary IDs||11-106 METC ErasmusMC|
|- Public Title||Study of the possible factors of influence on the decision to partipate in early clinical cancer trials.|
|- Scientific Title||Prospective exploring study of factors which can influence the decision to participate in early clinical cancer trials.|
|- hypothesis||Exploring QOL, hope, treatment motivition, coping en locus of control of patients considering early clinical cancer trial participation. |
|- Healt Condition(s) or Problem(s) studied||Solid tumors, Participation, Phase I trial, Phase II trial|
|- Inclusion criteria||Patients considering participation on a phase I or phase II trial for the first time.|
|- Exclusion criteria||1. Prior participation in phase I or II trial;|
2. Age under 18 years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||12-apr-2011|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||100|
|- Primary outcome||Outcome: |
The influence of ‘motivation for treatment, hope, coping, locus of control and quality of life’ on the decision whether or not to participate in a phase I or phase II cancer trial.
Participation or non participation in a phase I or II cancer trial, motivation for treatment, hope, coping, locus of control and quality of life’.
The influence of ‘motivation for treatment, hope, coping, locus of control and quality of life’ will be measured using a questionair on different timepoint. The questionnaire contains 5 subquestionnaires:
1. Validated 12 items motivation questionnaire by Prochaska en DiClemente;
2. Validated 30 items coping questionnaire by Brandtstadter and Renner;
3. Validated 19 item questionnaire by of the Rotter locus of controle scale;
4. Validates 12 items questionnaire of the Herth Hope Index;
5. Quality of life is measured with the EORTC QLQ-C30, 3.0.
|- Secondary outcome||1. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ at the start and end of the informed consent period;|
2. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ between patients who consent or do not consent to treatment in a phase I or phase II cancer trial;
3. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ between patients who will or will not continue treatment after first response evaluation.
|- Timepoints||1. Before deciding participation in a phase I or II trial;|
2. After deciding to participate in a phase I or II trial;
3. When participating after the first evaluation of the effect of the treatment.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Ms. A.J. Biessen, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD Ron H.J. Mathijssen|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Trial participation of cancer patients lacking standard treatment options is crucial for the development of new anti-cancer drugs. The main reason to participate is hope for remission or even cure. This study investigates the relationship of motivation for treatment, coping, locus of control, hope and quality of life in patients considering a phase I or II clinical cancer trial. Insight in these relationships could improve individualised patient information, within the legal settings, during the informed consent procedure and trial participation.|
|- Main changes (audit trail)|
|- RECORD||27-feb-2012 - 24-jun-2015|