Study of the possible factors of influence on the decision to partipate in early clinical cancer trials.

Prospective exploring study of factors which can influence the decision to participate in early clinical cancer trials.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20050

Enrollment

100

Registered

2012-02-27

Start date

2011-04-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with solid tumors without standard treatment options considering participation in a phase I or phase II trial

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients considering participation on a phase I or phase II trial for the first time.

Exclusion criteria

Exclusion criteria: 1. Prior participation in phase I or II trial; 2. Age under 18 years.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactA.J. Biessen, van der

ErasmusMC Daniel Room G4-83 Groene Hilledijk 301

a.vanderbiessen@erasmusmc.nl+31 (0)10 7041132

Outcome results