Distress In CErvical Cancer Patients and Partners

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.

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.