Cancer Patients in Clinical Trials and Their Relatives

NCT03759054 | Completed DMC

• 1 other identifier: Fase 1 patienter
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Aims The aims of this study are:

1. 1.To characterize patients' psychological well-being from the time they are referred to a phase I trial and determine risk factors for poor well-being.
2. 2.To investigate perceived information, expectations and regret when a patient participate in a phase I trial.

Conditions

Depression, Anxiety; Information Disclosure

Outcome Measures

Primary Outcomes (4)

• Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.

  Among patients and relatives

  First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year

• Anixiety assessed by Generalized Anxiety Disorder scale, total score (range 0-21), higher score indicates a higher level of anxiety.

  Among patients and relatives

  First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year

• Depression assessed by Patient Health Questionnaire, total score (range 0-28), higher scoreindicates a higher level of depression.

  Among patients and relatives

  First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year

• Physical functioning assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, subscale physical functioning, score (range 0-100), higher score indicates better physical functioning.

  Patients

  First visit, through study completion, an average of 1 year

Secondary Outcomes (10)

• Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge

  At baseline visit

• Regret assessed by Decision Regret Scale, total score (range 0-100), higher score indicates higher level of regret

  through study completion, an average of 1 year

• Question regarding motivations: How did you get to hear about the Phase 1 Unit? Descriptive distribution of answers.

  At baseline visit

• Question regarding motivations: Indicate your reasons for participating in clinical trial treatment by circling the relevant number. Descriptive distribution of answers.

  At baseline visit

• Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers.

  At baseline visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and referred to the Phase I Unit at the Department of Oncology, Rigshospitalet, and their closest relative will be invited to participate when they come for their first information dialogue in the department. The questionnaire can be filled out immediately after the dialogue if possible or filled out at home and sent or brought to the department at next appointment.

You may qualify if:

• patients referred to the Phase I Unit

You may not qualify if:

• patients who do not understand written Danish
• patients for whom contact information is missing

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Ulrik Lassen, MD

  Head of Department of Oncology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Oncology, professor

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: November 29, 2018
• Study Start: April 10, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)