Gynecologic CancerNCT03961217
Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
An observational study of Gynecologic Cancer and Prostate Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Gynecologic Cancer, Prostate Cancer, Radiation Toxicity
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 2,135 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1991to Dec 2016
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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,
Who cannot join
- No other chronic disease
- Chronic intestinal illness/surgery
- Stage IV cancer
- Recurrent cancer/Relapse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, 413 45
About this study
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).
Read the detailed description
Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.
Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.
However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.
The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).
There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.
- Conditions
- Gynecologic Cancer, Prostate Cancer, Radiation Toxicity, Malignancy, Radiotherapy Side Effect, Radiation Injuries
- Being tested
- Radiotherapy
- Keywords
- Return to work, Disability pension, Sickness Absence, Employability, Fitness to work, Wellbeing, Radiotherapy Side Effect, Cancer Survivors
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy as part of cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiotherapy | |
| Prostate Cases | Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden Receives: Radiation: Radiotherapy | |
| Gynecological Rehab Cases | Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work (RTW)
Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.
Measured: Five - Ten years after mapping Radiation-induced survivorship syndromes
Secondary outcomes (1)
Time to Return to work
Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.
Measured: Five - Ten years after mapping Radiation-induced survivorship syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study startJan 1991
- Primary completionOct 2006
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,135 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Gunnar Steineck, Sahlgrenska University Hospital
- Investigators
- Gunnar Steineck, Principal investigator, Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961217
- Sponsor's protocol ID
- ANB_691-17
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28158314Dunberger 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.
PubMed 19926277Alsadius 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.
PubMed 21737169Lind 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.
PubMed 21847122Noor 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.
PubMed 37489096Baloch 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.
PubMed 34414517
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
- ClinicalTrials.gov ID
- NCT03961217
- Acronym / sponsor ID
- ANB_691-17
- Conditions
- Gynecologic Cancer, Prostate Cancer, Radiation Toxicity, Malignancy, Radiotherapy Side Effect, Radiation Injuries
- Keywords
- Return to work, Disability pension, Sickness Absence, Employability, Fitness to work, Wellbeing, Radiotherapy Side Effect, Cancer Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,135 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Jan 1991 (actual)
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.
Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.
However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.
The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).
There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gynecological Cases | – | Radiation: RadiotherapyGynecological 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. |
| Prostate Cases | – | Radiation: RadiotherapyProstate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden |
| Gynecological Rehab Cases | – | Radiation: RadiotherapyGynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (4 listed)
- No other chronic disease
- Chronic intestinal illness/surgery
- Stage IV cancer
- Recurrent cancer/Relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy as part of cancer treatment | Radiation | Gynecological Cases, Gynecological Rehab Cases, Prostate Cases |
Primary outcome
Return to work (RTW)
Time frame: Five - Ten years after mapping Radiation-induced survivorship syndromes
Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.
1 secondary outcome
Time to Return to work
Time frame: Five - Ten years after mapping Radiation-induced survivorship syndromes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Background: PubMed 28158314Steineck 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.
- Background: PubMed 19926277Dunberger 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.
- Background: PubMed 21737169Alsadius 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.
- Background: PubMed 21847122Lind 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.
- Derived from this study: PubMed 37489096Noor 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.
- Derived from this study: PubMed 34414517Baloch 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.
- Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controlsLink provided by the sponsor.
- Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivorsLink provided by the sponsor.
- Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancerLink provided by the sponsor.
- Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Steineck principal investigator
Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Prostate Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (RTW) (time frame: Five - Ten years after mapping Radiation-induced survivorship syndromes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03961217, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.