NCT04083300

Brief Summary

This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on cancer-related stress reactions and emotional reactivity between the intervention and control group. Secondary objectives is to investigate consequences of cancer and its' treatment over time, such as long term quality of life, objectively physical activity and experiences concerning follow-up and the transition from specialist health services to municipal health services.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 10, 2021

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

June 18, 2019

Last Update Submit

February 8, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.

    2021

  • Objectively measured physical activity from diagnosis to 6-8 years follow up.

    2022

  • The context between change in physical activity and quality of life over time

    2023

  • Witch predictors has an impact on long term cancer survivors quality of life?

    2024

Secondary Outcomes (1)

  • Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study

    2021

Other Outcomes (1)

  • The participants ability to work during the 5-years follow-up, using official register data and questionnaires.

    2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cancer survivors who participated in the early "Early rehabilitation of cancer patients" (ClinicalTrials.gov Identifier: NCT 01588262) were asked to join this follow up study.

You may qualify if:

  • Stage I-III disease
  • Scheduled for neo/adjuvant or curative treatment (i.e. chemotherapy, radiation therapy or hormonal therapy or any combination of these therapies)

You may not qualify if:

  • On-going psychiatric condition
  • Lack of fluency in Norwegian
  • A previous diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

NeoplasmsStress Disorders, TraumaticFatigueMotor Activity

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

September 10, 2019

Study Start

January 3, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 10, 2021

Record last verified: 2020-01

Locations