Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: a multicenter study

Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: a multicenter study - TIME-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32529

Enrollment

255

Registered

2008-10-24

Start date

2008-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

breast cancer breast neoplasm

Interventions

Women in the RGCT arm of the study will be referred for genetic counseling within a week after diagnosis, prior to the primary surgery. Genetic counseling will take place at the NKI-AVL or the UMC U

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: women with breast cancer, with an indication for genetic counseling and dna-testing.

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
Standardized questionnaires will be administered to all patients at study entry, and at 6 and 12 months to assess all psychosocial outcomes. The study endpoints will include: (1) the choice of clinical management strategy, including the uptake of direct bilateral mastectomy (BLM) or of delayed preventive contralateral mastectomy (PCM); (2) cancer risk perception, cancer-related worry and distress; (3) knowledge of genetic aspects of breast cancer; (4) decisional satisfaction; and (5) health-related quality of life (HRQL).The study will also evaluate women*s experience of and satisfaction with RGCT (i.e., the timing and quality of the services provided, the perceived impact on treatment decisions, perceived need for additional psychosocial services, etc.). Data on surgical outcomes will be abstracted from the medical records. A subset of women will be interviewed to obtain supplementary, qualitative data about the RGCT experience.	—

Measure

Time frame

Standardized questionnaires will be administered to all patients at study entry, and at 6 and 12 months to assess all psychosocial outcomes. The study endpoints will include: (1) the choice of clinical management strategy, including the uptake of direct bilateral mastectomy (BLM) or of delayed preventive contralateral mastectomy (PCM); (2) cancer risk perception, cancer-related worry and distress; (3) knowledge of genetic aspects of breast cancer; (4) decisional satisfaction; and (5) health-related quality of life (HRQL).The study will also evaluate women*s experience of and satisfaction with RGCT (i.e., the timing and quality of the services provided, the perceived impact on treatment decisions, perceived need for additional psychosocial services, etc.). Data on surgical outcomes will be abstracted from the medical records. A subset of women will be interviewed to obtain supplementary, qualitative data about the RGCT experience.

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Secondary

Measure	Time frame
See primary study parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)