NCT03961217

Brief Summary

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW. In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,135

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1991

Longer than P75 for all trials

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 1, 1991

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
10.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

15.8 years

First QC Date

May 22, 2019

Last Update Submit

May 23, 2019

Conditions

Gynecologic CancerProstate CancerRadiation ToxicityMalignancyRadiotherapy Side EffectRadiation InjuriesCancer SurvivorsRadiation Syndrome

Keywords

Return to workDisability pensionSickness AbsenceEmployabilityFitness to workWellbeingRadiotherapy Side EffectCancer Survivors

Outcome Measures

Primary Outcomes (1)

  • Return to work (RTW)

    Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.

    Five - Ten years after mapping Radiation-induced survivorship syndromes

Secondary Outcomes (1)

  • Time to Return to work

    Five - Ten years after mapping Radiation-induced survivorship syndromes

Study Arms (3)

Gynecological Cases

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at 1. Radiumhemmat, Karolinska University Hospital and 2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.

Radiation: Radiotherapy

Prostate Cases

Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden

Radiation: Radiotherapy

Gynecological Rehab Cases

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Radiotherapy as part of cancer treatment

Gynecological CasesGynecological Rehab CasesProstate Cases

Eligibility Criteria

Age25 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGyaecological cancer survivors Prostate cancer survivors
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cohort of women treated with external pelvic radiotherapy for a gynaecological malignancy and men treated with radiotherapy for prostate cancer at two large oncology clinics in Sweden.

You may qualify if:

  • Age 25 to 60 years (working age)
  • Employed at time of diagnosis
  • Treated for cancer
  • Suffering from at least one of Radiation-induced survivorship syndromes
  • First cancer \& first time treatment for cancer,

You may not qualify if:

  • No other chronic disease
  • Chronic intestinal illness/surgery
  • Stage IV cancer
  • Recurrent cancer/Relapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (6)

  • Steineck G, Skokic V, Sjoberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderang U, Oh JH, Deasy JO, Jornsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.

    PMID: 28158314BACKGROUND

  • Dunberger G, Lind H, Steineck G, Waldenstrom AC, Nyberg T, Al-Abany M, Nyberg U, Vall-Lundqvist E. Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controls. Eur J Cancer. 2010 Feb;46(3):606-15. doi: 10.1016/j.ejca.2009.10.023. Epub 2009 Nov 18.

    PMID: 19926277BACKGROUND

  • Alsadius D, Hedelin M, Johansson KA, Pettersson N, Wilderang U, Lundstedt D, Steineck G. Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancer. Radiother Oncol. 2011 Dec;101(3):495-501. doi: 10.1016/j.radonc.2011.06.010. Epub 2011 Jul 5.

    PMID: 21737169BACKGROUND

  • Lind H, Waldenstrom AC, Dunberger G, al-Abany M, Alevronta E, Johansson KA, Olsson C, Nyberg T, Wilderang U, Steineck G, Avall-Lundqvist E. Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study. Br J Cancer. 2011 Sep 6;105(6):737-45. doi: 10.1038/bjc.2011.315. Epub 2011 Aug 16.

    PMID: 21847122BACKGROUND

  • Noor Baloch A, Hagberg M, Thomee S, Steineck G, Sanden H. The physical and psychological aspects of quality of life mediates the effect of radiation-induced urgency syndrome on disability pension in gynecological cancer survivors. Cancer Med. 2023 Aug;12(16):17377-17388. doi: 10.1002/cam4.6356. Epub 2023 Jul 24.

    PMID: 37489096DERIVED

  • Baloch AN, Hagberg M, Thomee S, Steineck G, Sanden H. Disability pension among gynaecological cancer survivors with or without radiation-induced survivorship syndromes. J Cancer Surviv. 2022 Aug;16(4):834-843. doi: 10.1007/s11764-021-01077-9. Epub 2021 Aug 19.

    PMID: 34414517DERIVED

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsRadiation InjuriesNeoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gunnar Steineck

    Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Senior consultant

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

January 1, 1991

Primary Completion

October 1, 2006

Study Completion

December 1, 2016

Last Updated

May 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)