Distress In CErvical Cancer Patients and Partners
Schlüsselwörter
Abstrakt
Beschreibung
Study design: Prospective population-based study in which cervical cancer patients and their partners are included shortly after diagnosis and followed until 10 years after diagnosis. Patients from treatment centres in the Netherlands and their partners will be asked to complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Clinical data like disease stage, initial treatment and mortality will be extracted from the Netherlands Cancer Registry. In a subsample of patients, additionally objective lifestyle (actigraph, biosensor) and biological (blood, hair) measures are assessed at diagnosis and after 6, 12 and 24 months. .
Study population: Newly diagnosed stage 1-3 cervical cancer patients (N=520) and their partners (N=312, expected) from any treatment centre in the Netherlands will be asked to fill out questionnaires. In a subsample of patients (N=116) additionally lifestyle and biological measures are assessed at all time-points.
Main study parameters/endpoints: psychological distress (anxiety, depression, perceived stress, cancer worry)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients and partners are asked to complete a questionnaire at 6 points in time: after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Patients will additionally be asked to complete an online food diary for 3 days. A subsample of patients will be asked to donate blood samples (2X10 ml, 10 minutes) to assess inflammation markers and telomere length, to donate a scalp hair sample (10 mg) to assess hormone production after diagnosis and after 6, 12 and 24 months, and to wear an Actigraph activity tracker to assess physical activity and sleep and a Philips Biosensor to assess heart rate variability as a marker of vagal nerve function at 6, 12 and 24 months.
Termine
Zuletzt überprüft: | 06/30/2020 |
Zuerst eingereicht: | 01/15/2020 |
Geschätzte Einschreibung eingereicht: | 07/13/2020 |
Zuerst veröffentlicht: | 07/16/2020 |
Letztes eingereichtes Update: | 07/13/2020 |
Letztes Update veröffentlicht: | 07/16/2020 |
Tatsächliches Startdatum der Studie: | 06/30/2020 |
Geschätztes primäres Abschlussdatum: | 12/31/2023 |
Voraussichtliches Abschlussdatum der Studie: | 12/31/2029 |
Zustand oder Krankheit
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
Cervical cancer patients and their partners 520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years |
Zulassungskriterien
Altersberechtigt für das Studium | 18 Years Zu 18 Years |
Studienberechtigte Geschlechter | All |
Probenahmeverfahren | Probability Sample |
Akzeptiert gesunde Freiwillige | Nein |
Kriterien | Patients Inclusion Criteria: - Newly diagnosed with cervical cancer stage I, II or III - >18 years or older Exclusion Criteria: - Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance. - Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire. Partners Inclusion Criteria: - Partner of patient participating in the study - >18 years Exclusion Criteria: - Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance. - Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire. |
Ergebnis
Primäre Ergebnismaße
1. Anxiety/ depression [24 months]
Sekundäre Ergebnismaße
1. Cancer worry [24 months]
2. Perceived stress [24 months]
3. Health-related quality of life [24 months]
4. Cervical cancer health-related quality of life [24 months]
5. Sexual Health [24 months]