No registrations found.
ID
Source
Health condition
Patients with solid tumors without standard treatment options considering participation in a phase I or phase II trial
Sponsors and support
Intervention
Outcome measures
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.
Outcome Name:
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.
Background 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.
Study objective
Exploring QOL, hope, treatment motivition, coping en locus of control of patients considering early clinical cancer trial participation.
Study design
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.
Intervention
N/A
Room G4-83<br>
Groene Hilledijk 301
A.J. Biessen, van der
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041132
a.vanderbiessen@erasmusmc.nl
Room G4-83<br>
Groene Hilledijk 301
A.J. Biessen, van der
Rotterdam 3075 EA
The Netherlands
+31 (0)10 7041132
a.vanderbiessen@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3203 |
| NTR-old | NTR3354 |
| Other | METC ErasmusMC : 11-106 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |